Pulmonary Disease, Chronic ObstructivePhase 3NCT01313676
Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease
A Phase 3 study testing fluticasone furoate/vilanterol, fluticasone furoate and vilanterol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1,611 sites in 44 countries.
Trial summary
The purpose of this study is to determine if fluticasone furoate/vilanterol improves survival in patients with chronic obstructive pulmonary disease with a history of or increased risk of heart disease. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- fluticasone furoate/vilanterol, fluticasone furoate and vilanterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16,568 participants
- Where
- 1,611 sitesin 44 countries
- Study dates
- 25 Jan 2011to 15 Jul 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type of subject: outpatient.
- Informed consent: Subjects must give their signed and dated written informed consent to participate.
- Gender: Male or female. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception.
- Age: >=40 and <=80 years of age at Screening (Visit 1).
- Tobacco use: Subjects with a current or prior history of >=10 pack-years of cigarette smoking at screening (Visit 1). Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
- Airflow Obstruction:
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- Subjects with a measured post-albuterol/salbutamol forced expiratory volume in 1 second (FEV1)/(forced vital capacity)FVC ratio of <=0.70 at Screening (Visit 1).
- Subjects with a measured post-albuterol/salbutamol FEV1 >=50 and <=70% of predicted normal values calculated using NHANES III reference equations [Hankinson, 1999; Hankinson, 2010] at Screening (Visit 1).
- Post-bronchodilator spirometry will be performed approximately 15 minutes after the subject has self-administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via a metered dose inhaler (MDI )with a valved-holding chamber. The FEV1/FVC ratio and FEV1 percent predicted values will be calculated.
- Symptoms of COPD: Subjects must score 2 or higher on the modified Medical Research Council Dyspnea scale (Visit 1)
- Cardiovascular disease:
- For patients >= 40 years of age: any one of the following:
- Established (i.e. by clinical signs or imaging studies) coronary artery disease (CAD) Established (i.e. by clinical signs or imaging studies) peripheral vascular disease (PVD) Previous stroke Previous MI Diabetes mellitus with target organ disease OR
- For patients >=60 years of age: any 2 of the following:
- Being treated for hypercholesterolemia Being treated for hypertension Being treated for diabetes mellitus Being treated for peripheral vascular disease
Who cannot join
- Pregnancy: Women who are pregnant or lactating.
- Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they also have a current diagnosis of COPD).
- alpha 1-antitrypsin deficiency: Subjects with known alpha-1 antitrypsin deficiency as the underlying cause of COPD.
- Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
- Lung resection or transplantation: Subjects with lung volume reduction surgery within the 12 months prior to Screening or having had a lung transplant.
- A moderate/severe COPD exacerbation that has not resolved at least 14 days prior to Visit 1 and at least 30 days following the last dose of oral corticosteroids (if applicable).
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- Current severe heart failure (New York Heart Association class IV). Subjects will also be excluded if they have a known ejection fraction of <30% or if they have an implantable cardioverter defibrillator (ICD).
- Other diseases/abnormalities: Any life-threatening condition with life expectancy <3 years, other than vascular disease or COPD, that might prevent the subject from completing the study.
- End stage chronic renal disease: Subjects will be excluded if on renal replacement therapy (hemodialysis or peritoneal).
- Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g. beta-agonists, corticosteroid) or components of the inhalation powder (e.g. lactose, magnesium stearate). In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subject's participation will also be excluded.
- Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years.
- Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e. <=12 hours per day) is not exclusionary.
- Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study or the potential compliance to study procedures.
- Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.
- Additional medication: Use of the following medications within the following time intervals prior to Visit 1 or during the study (unless otherwise specified):
- Medication No use within the following time intervals prior to Screening or thereafter at any time during the study (unless otherwise specified) Inhaled Long acting beta-agonists (LABA) 48 hours ICS/LABA combination products 48 hours Inhaled corticosteroids 48 hours Tiotropium 1 week Systemic, Oral, parenteral, intra-articular corticosteroids 30 days (oral and systemic corticosteroids may be used to treat COPD exacerbations during the study) Cytochrome P450 3A4 strong inhibitors including but not limited to antiretrovirals (protease inhibitors) (e.g.Indinavir, Nelfinavir, Ritonavir, Saquinavir); Imidazole and Triazole anti-fungals (e.g. Ketaconazole, Itraconazole); Clarithromycin, Telithromycin, Amiodarone, and Nefazodone 6 weeks Grapefruit is allowed up to Visit 1, then limited to no more than one glass of grapefruit juice (250 mL/ 8 ounces) or one grapefruit per day Any other investigational drug 30 days or 5 half lives whichever is longer.
Trial locations and contacts
1,611 sites in 44 countries.
1405 sites in 44 countries
United States300 sites
GSK Investigational Site
Abingdon, Virginia, 24210
GSK Investigational Site
Akron, Ohio, 44313
GSK Investigational Site
Albany, New York, 12208
GSK Investigational Site
Albuquerque, New Mexico, 87108
GSK Investigational Site
Alexandria, Virginia, 22304
GSK Investigational Site
Altamonte Springs, Florida, 32714
GSK Investigational Site
Amarillo, Texas, 79124
GSK Investigational Site
Anaheim, California, 92801
GSK Investigational Site
Andalusia, Alabama, 36420
GSK Investigational Site
Anderson, South Carolina, 29621
GSK Investigational Site
Ann Arbor, Michigan, 48106
GSK Investigational Site
Asheville, North Carolina, 28801
GSK Investigational Site
Athens, Alabama, 35611
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Atlanta, Georgia, 30342
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Auburn, Maine, 04210
GSK Investigational Site
Aurora, Illinois, 60504
GSK Investigational Site
Austell, Georgia, 30106
GSK Investigational Site
Austin, Texas, 78756
GSK Investigational Site
Austin, Texas, 78758
GSK Investigational Site
Aventura, Florida, 33180
GSK Investigational Site
Avon, Indiana, 46123
GSK Investigational Site
Bakersfield, California, 93301
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Baltimore, Maryland, 21201
GSK Investigational Site
Baltimore, Maryland, 21224
GSK Investigational Site
Baltimore, Maryland, 21239
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Bangor, Maine, 04401
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Bay Pines, Florida, 33744
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Beaver, Pennsylvania, 15009
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Belle Vernon, Pennsylvania, 15012
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Bellevue, Nebraska, 68123-4303
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Bellingham, Washington, 98225
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Bend, Oregon, 97701
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Bensalem, Pennsylvania, 19020
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Biddeford, Maine, 04005
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Billings, Montana, 59101
GSK Investigational Site
Billings, Montana, 59102
GSK Investigational Site
Birmingham, Alabama, 35209
GSK Investigational Site
Birmingham, Alabama, 35216
GSK Investigational Site
Birmingham, Alabama, 35233
GSK Investigational Site
Birmingham, Alabama, 35242
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Blue Ridge, Georgia, 30513
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Boerne, Texas, 78006
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Boise, Idaho, 83642
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Bowling Green, Kentucky, 42101
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Boynton Beach, Florida, 33435
GSK Investigational Site
Boynton Beach, Florida, 33472
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Brandon, Florida, 33511
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Brick, New Jersey, 08723
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Bridgeport, West Virginia, 26330
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Brockton, Massachusetts, 02301
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Bronxville, New York, 10708
GSK Investigational Site
Brooklyn, New York, 11215
GSK Investigational Site
Brooklyn, New York, 11229
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Buckley, Michigan, 49620
GSK Investigational Site
Buffalo, New York, 14215-1199
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Burien, Washington, 98166
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Burke, Virginia, 22015
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Butte, Montana, 59701
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Cadillac, Michigan, 49601
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Calabash, North Carolina, 28467
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Calhoun, Georgia, 30701
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Canton, Georgia, 30114
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Celebration, Florida, 34747
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Centennial, Colorado, 80112
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Cerritos, California, 90703
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Champaign, Illinois, 61820
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Chardon, Ohio, 44024
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Charleston, South Carolina, 29406-7108
GSK Investigational Site
Charleston, South Carolina, 29407
GSK Investigational Site
Charlotte, North Carolina, 28209
GSK Investigational Site
Charlotte, North Carolina, 28210
GSK Investigational Site
Chattanooga, Tennessee, 37404
GSK Investigational Site
Chesterfield, Missouri, 63017
GSK Investigational Site
Chicago, Illinois, 60603
GSK Investigational Site
Chicago, Illinois, 60612
GSK Investigational Site
Cincinnati, Ohio, 45220
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Cincinnati, Ohio, 45242
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Clairton, Pennsylvania, 15025
GSK Investigational Site
Clearwater, Florida, 33755
GSK Investigational Site
Clearwater, Florida, 33756
GSK Investigational Site
Clearwater, Florida, 33759
GSK Investigational Site
Clearwater, Florida, 33765-2616
GSK Investigational Site
Clearwater, Florida, 33765
GSK Investigational Site
Cleveland, Ohio, 44106
GSK Investigational Site
Cleveland, Ohio, 44109
GSK Investigational Site
Cleveland, Ohio, 44122
GSK Investigational Site
Coeur d'Alene, Idaho, 90212
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Colorado Springs, Colorado, 80907
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Colorado Springs, Colorado, 80910
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Columbia, Maryland, 21044
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Columbia, South Carolina, 29201
GSK Investigational Site
Columbia, South Carolina, 29209
GSK Investigational Site
Columbus, Georgia, 31904
GSK Investigational Site
Columbus, Ohio, 43213
GSK Investigational Site
Columbus, Ohio, 43214
GSK Investigational Site
Columbus, Ohio, 43215
GSK Investigational Site
Columbus, Ohio, 43235
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Coon Rapids, Minnesota, 55433
GSK Investigational Site
Corning, New York, 14830
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Corpus Christi, Texas, 78405
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Corsicana, Texas, 75110
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Council Bluffs, Iowa, 51503
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Crestview Hills, Kentucky, 41017
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Crystal River, Florida, 34429
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Cumberland, Rhode Island, 02864
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Cumming, Georgia, 30041
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Dakota Dunes, South Dakota, 57049
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Dallas, Texas, 75216
GSK Investigational Site
Dallas, Texas, 75225
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
Dallas, Texas, 75254
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Danbury, Connecticut, 06810
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Dayton, Ohio, 45406
GSK Investigational Site
Dayton, Ohio, 45459
GSK Investigational Site
Daytona Beach, Florida, 32117
GSK Investigational Site
DeBary, Florida, 32173
GSK Investigational Site
Decatur, Georgia, 30033
GSK Investigational Site
DeLand, Florida, 32720
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Denver, Colorado, 80206
GSK Investigational Site
Detroit, Michigan, 48201
GSK Investigational Site
Detroit, Michigan, 48221
GSK Investigational Site
Detroit, Michigan, 48235
GSK Investigational Site
Downingtown, Pennsylvania, 19335
GSK Investigational Site
Doylestown, Pennsylvania, 18901
GSK Investigational Site
Dubuque, Iowa, 52001
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Duncanville, Texas, 75116
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Easley, South Carolina, 29640
GSK Investigational Site
East Providence, Rhode Island, 02914
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Edgewater, Florida, 32132
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Edina, Minnesota, 55435
GSK Investigational Site
Edinburg, Texas, 78539
GSK Investigational Site
Edison, New Jersey, 8820
GSK Investigational Site
Elizabeth, New Jersey, 07201
GSK Investigational Site
Elizabeth, New Jersey, 07202
GSK Investigational Site
Elizabeth City, North Carolina, 27909
GSK Investigational Site
Elkton, Maryland, 21921
GSK Investigational Site
Elwood, Indiana, 46036
GSK Investigational Site
Encinitas, California, 92024
GSK Investigational Site
Erie, Pennsylvania, 16508
GSK Investigational Site
Evansville, Indiana, 47714
GSK Investigational Site
Evergreen Park, Illinois, 60805
GSK Investigational Site
Fall River, Massachusetts, 02720
GSK Investigational Site
Fayetteville, Arkansas, 72703
GSK Investigational Site
Fayetteville, Tennessee, 37334
GSK Investigational Site
Flagstaff, Arizona, 86001
GSK Investigational Site
Fleetwood, Pennsylvania, 19522
GSK Investigational Site
Fleming Island, Florida, 32003
GSK Investigational Site
Florence, South Carolina, 29501
GSK Investigational Site
Foothill Ranch, California, 92610
GSK Investigational Site
Fort Collins, Colorado, 80528
GSK Investigational Site
Fort Collins, Colorado, 80538
GSK Investigational Site
Fort Lauderdale, Florida, 33316
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Franklin, Indiana, 46131
GSK Investigational Site
Franklin, Tennessee, 27064
GSK Investigational Site
Freehold, New Jersey, 07728
GSK Investigational Site
Fremont, Nebraska, 68025
GSK Investigational Site
Fridley, Minnesota, 55432
GSK Investigational Site
Frisco, Texas, 75034
GSK Investigational Site
Frisco, Texas, 75035
GSK Investigational Site
Gaffney, South Carolina, 29340
GSK Investigational Site
Gainesville, Florida, 32608
GSK Investigational Site
Gainesville, Georgia, 30501
GSK Investigational Site
Galveston, Texas, 77555
GSK Investigational Site
Garden Grove, California, 92844
GSK Investigational Site
Georgetown, Texas, 78626
GSK Investigational Site
Gillespie, Illinois, 62033
GSK Investigational Site
Glendale, Arizona, 85306
GSK Investigational Site
Gold River, California, 95670
GSK Investigational Site
Grand Blanc, Michigan, 48439
GSK Investigational Site
Grand Island, Nebraska, 68803
GSK Investigational Site
Great Falls, Montana, 59405
GSK Investigational Site
Great Neck, New York, 11023
GSK Investigational Site
Greenfield, Indiana, 46140
GSK Investigational Site
Greensboro, North Carolina, 27401
GSK Investigational Site
Greensboro, North Carolina, 27403
GSK Investigational Site
Greensboro, North Carolina, 27405
GSK Investigational Site
Greensboro, North Carolina, 27408
GSK Investigational Site
Greenville, North Carolina, 27858
GSK Investigational Site
Greenville, South Carolina, 29615
GSK Investigational Site
Greenwood, South Carolina, 29646
GSK Investigational Site
Greer, South Carolina, 29650
GSK Investigational Site
Greer, South Carolina, 29651
GSK Investigational Site
Hagerstown, Maryland, 21740
GSK Investigational Site
Harleysville, Pennsylvania, 19438
GSK Investigational Site
Hartford, Connecticut, 06105
GSK Investigational Site
Hawesville, Kentucky, 42348
GSK Investigational Site
Hayden Lake, Idaho, 83835
GSK Investigational Site
Hazard, Kentucky, 41701
GSK Investigational Site
Henderson, Nevada, 89014
GSK Investigational Site
Hialeah, Florida, 33012
GSK Investigational Site
Hialeah, Florida, 33013
GSK Investigational Site
Hialeah, Florida, 33016
GSK Investigational Site
High Point, North Carolina, 27262
GSK Investigational Site
Hollywood, Florida, 33021
GSK Investigational Site
Hollywood, Maryland, 20636
GSK Investigational Site
Honolulu, Hawaii, 96813
GSK Investigational Site
Houston, Texas, 77024
GSK Investigational Site
Houston, Texas, 77025
GSK Investigational Site
Houston, Texas, 77029
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Houston, Texas, 77034
GSK Investigational Site
Houston, Texas, 77043
GSK Investigational Site
Houston, Texas, 77062
GSK Investigational Site
Houston, Texas, 77074
GSK Investigational Site
Houston, Texas, 77077
GSK Investigational Site
Houston, Texas, 77079
GSK Investigational Site
Houston, Texas, 77081
GSK Investigational Site
Houston, Texas, 77099
GSK Investigational Site
Huntersville, North Carolina, 28078
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Huntington Park, California, 90255
GSK Investigational Site
Huntsville, Alabama, 35801
GSK Investigational Site
Huntsville, Alabama, 35816
GSK Investigational Site
Huntsville, Texas, 77340
GSK Investigational Site
Idaho Falls, Idaho, 83402
GSK Investigational Site
Iowa City, Iowa, 52242
GSK Investigational Site
Irving, Texas, 75039
GSK Investigational Site
Jacksonville, Florida, 32209
GSK Investigational Site
Jacksonville, Florida, 32216
GSK Investigational Site
Jersey Shore, Pennsylvania, 17740
GSK Investigational Site
Johnston, Rhode Island, 02919
GSK Investigational Site
Jonesboro, Arkansas, 72401
GSK Investigational Site
Kalamazoo, Michigan, 49009
GSK Investigational Site
Kansas City, Missouri, 64106
GSK Investigational Site
Kansas City, Missouri, 64128
GSK Investigational Site
Kettering, Ohio, 45429
GSK Investigational Site
Killeen, Texas, 76543
GSK Investigational Site
Kingwood, Texas, 77339
GSK Investigational Site
Kissimmee, Florida, 34741
GSK Investigational Site
Knightdale, North Carolina, 27545
GSK Investigational Site
Lafayette, Louisiana, 70508
GSK Investigational Site
Lakewood, California, 90712
GSK Investigational Site
Lancaster, California, 93534
GSK Investigational Site
Langhorne, Pennsylvania, 19047
GSK Investigational Site
Lansdale, Pennsylvania, 19446
GSK Investigational Site
Las Vegas, Nevada, 89106
GSK Investigational Site
Las Vegas, Nevada, 89119
GSK Investigational Site
Lawrenceville, Georgia, 30046
GSK Investigational Site
Leesburg, Florida, 34748
GSK Investigational Site
Lehigh Acres, Florida, 33971
GSK Investigational Site
Lewisville, Texas, 75067
GSK Investigational Site
Lexington, Kentucky, 40504
GSK Investigational Site
Lexington, North Carolina, 27295
GSK Investigational Site
Lincoln, Nebraska, 02865
GSK Investigational Site
Lincoln, Nebraska, 68506
GSK Investigational Site
Lincoln, Nebraska, 68512
GSK Investigational Site
Lincoln, Nebraska, 68516
GSK Investigational Site
Linden, New Jersey, 07036
GSK Investigational Site
Lodi, New Jersey, 07644
GSK Investigational Site
Loma Linda, California, 92357
GSK Investigational Site
Long Beach, California, 90822
GSK Investigational Site
Longview, Texas, 75605
GSK Investigational Site
Los Angeles, California, 90033
GSK Investigational Site
Los Angeles, California, 90036
GSK Investigational Site
Los Angeles, California, 90048
GSK Investigational Site
Los Angeles, California, 90095
GSK Investigational Site
Louisville, Kentucky, 40202
GSK Investigational Site
Lufkin, Texas, 75904
GSK Investigational Site
Lutherville, Maryland, 21093
GSK Investigational Site
Maitland, Florida, 32751
GSK Investigational Site
Manhattan, New York, 10029
GSK Investigational Site
Margate City, New Jersey, 08402
GSK Investigational Site
Marietta, Georgia, 30060
GSK Investigational Site
Marion, Ohio, 43302
GSK Investigational Site
Massapequa, New York, 11758
GSK Investigational Site
Maumee, Ohio, 43537-9402
GSK Investigational Site
McKinney, Texas, 75069
GSK Investigational Site
McKinney, Texas, 75071
GSK Investigational Site
Melbourne, Florida, 32934
GSK Investigational Site
Melrose Park, Illinois, 60160
GSK Investigational Site
Metairie, Louisiana, 70006
GSK Investigational Site
Miami, Florida, 33015
GSK Investigational Site
Miami, Florida, 33125
GSK Investigational Site
Miami, Florida, 33126
GSK Investigational Site
Miami, Florida, 33133
GSK Investigational Site
Miami, Florida, 33135
GSK Investigational Site
Miami, Florida, 33142
GSK Investigational Site
Miami, Florida, 33144
GSK Investigational Site
Miami, Florida, 33155
GSK Investigational Site
Miami, Florida, 33165
GSK Investigational Site
Miami, Florida, 33174
GSK Investigational Site
Miami, Florida, 33175
GSK Investigational Site
Miami, Florida, 33185
GSK Investigational Site
Miami, Florida, 33186
GSK Investigational Site
Miami Gardens, Florida, 33169
GSK Investigational Site
Miamisburg, Ohio, 45342
GSK Investigational Site
Midlothian, Virginia, 23114
GSK Investigational Site
Midvale, Utah, 84047
GSK Investigational Site
Minneapolis, Minnesota, 55402
GSK Investigational Site
Minneapolis, Minnesota, 55407
GSK Investigational Site
Minneapolis, Minnesota, 55417
GSK Investigational Site
Mission Hills, California, 91345
GSK Investigational Site
Mission Viejo, California, 92691
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Missoula, Montana, 59808
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Mobile, Alabama, 36604
GSK Investigational Site
Mobile, Alabama, 36608
GSK Investigational Site
Modesto, California, 95350
Russia114 sites
GSK Investigational Site
Arkhangelsk, 163001
GSK Investigational Site
Arkhangelsk, 163061
GSK Investigational Site
Barnaul, 656024
GSK Investigational Site
Barnaul, 656038
GSK Investigational Site
Chelyabinsk, 454021
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Chelyabinsk, 454047
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Chelyabinsk, 454091
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Gatchina, 188300
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Ivanovo, 153462
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Izhevsk, 426063
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Kaliningrad, 236016
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Kazan', 420012
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Kemerovo, 650000
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Kemerovo, 650002
GSK Investigational Site
Kirov, 610027
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Krasnoyarsk, 660022
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Kursk, 305035
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Moscow, 105066
GSK Investigational Site
Moscow, 107392
GSK Investigational Site
Moscow, 109263
GSK Investigational Site
Moscow, 111111
GSK Investigational Site
Moscow, 111539
GSK Investigational Site
Moscow, 115 280
GSK Investigational Site
Moscow, 115093
GSK Investigational Site
Moscow, 115432
GSK Investigational Site
Moscow, 115478
GSK Investigational Site
Moscow, 115516
GSK Investigational Site
Moscow, 115682
GSK Investigational Site
Moscow, 117292
GSK Investigational Site
Moscow, 117593
GSK Investigational Site
Moscow, 117630
GSK Investigational Site
Moscow, 117997
GSK Investigational Site
Moscow, 119002
GSK Investigational Site
Moscow, 119048
GSK Investigational Site
Moscow, 119049
GSK Investigational Site
Moscow, 119121
GSK Investigational Site
Moscow, 119229
GSK Investigational Site
Moscow, 119620
GSK Investigational Site
Moscow, 119991
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Moscow, 121 309
GSK Investigational Site
Moscow, 121374
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Moscow, 123060
GSK Investigational Site
Moscow, 123182
GSK Investigational Site
Moscow, 125205
GSK Investigational Site
Moscow, 125299
GSK Investigational Site
Moscow, 127018
GSK Investigational Site
Moscow, 129090
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Moscow, 129301
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Nizhny Novgorod, 603035
GSK Investigational Site
Novosibirsk, 630008
GSK Investigational Site
Novosibirsk, 630051
GSK Investigational Site
Novosibirsk, 630075
GSK Investigational Site
Novosibirsk, 630087
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Novosibirsk, 630091
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Novosibirsk, 630099
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Novosibirsk
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Orenburg, 460000
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Orenburg, 460018
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Perm, 614070
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Perm, 614097
GSK Investigational Site
Perm, 614111
GSK Investigational Site
Pskov, 180016
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Rostov-on-Don, 344022
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Ryazan, 390005
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Ryazan, 390026
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Ryazan, 390039
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Saint Petersburg, 190103
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Saint Petersburg, 191015
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Saint Petersburg, 191025
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Saint Petersburg, 192177
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Saint Petersburg, 192283
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Saint Petersburg, 193312
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Saint Petersburg, 194017
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Saint Petersburg, 194044
GSK Investigational Site
Saint Petersburg, 194354
GSK Investigational Site
Saint Petersburg, 194356
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Saint Petersburg, 195112
GSK Investigational Site
Saint Petersburg, 195257
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Saint Petersburg, 196084
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Saint Petersburg, 196601
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Saint Petersburg, 197022
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Saint Petersburg, 197089
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Saint Petersburg, 198103
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Saint Petersburg, 198260
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Saint Petersburg, 198328
GSK Investigational Site
Saint Petersburg, 199106
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Saratov, 410012
GSK Investigational Site
Saratov, 410018
GSK Investigational Site
Saratov, 410028
GSK Investigational Site
Saratov, 410039
GSK Investigational Site
Saratov, 410054
GSK Investigational Site
Sestroretsk, 197706
GSK Investigational Site
Smolensk, 214 019
GSK Investigational Site
Smolensk, 214006
GSK Investigational Site
St.Рetersburg, 198035
GSK Investigational Site
St'Petersburg, 193312
GSK Investigational Site
Tomsk, 634 050
GSK Investigational Site
Tomsk, 634012
GSK Investigational Site
Tomsk, 634050
GSK Investigational Site
Tomsk, 634063
GSK Investigational Site
Tver', 170036
GSK Investigational Site
Ufa, 450071
GSK Investigational Site
Ulyanovsk, 432063
GSK Investigational Site
Voronezh, 394018
GSK Investigational Site
Voronezh, 394066
GSK Investigational Site
Vsevolzhsk, 188640
GSK Investigational Site
Yaroslavl, 150002
GSK Investigational Site
Yaroslavl, 150003
GSK Investigational Site
Yaroslavl, 150010
GSK Investigational Site
Yaroslavl, 150023
GSK Investigational Site
Yaroslavl, 150062
GSK Investigational Site
Yekaterinburg, 620109
GSK Investigational Site
Yekaterinburg, 620137
GSK Investigational Site
Yekaterinburg, 620149
Poland95 sites
GSK Investigational Site
Bialystok, 15-003
GSK Investigational Site
Bialystok, 15-044
GSK Investigational Site
Bielsko-Biala, 43-300
GSK Investigational Site
Bielsko-Biala, 43-316
GSK Investigational Site
Bieńkówka, 34-212
GSK Investigational Site
Bydgoszcz, 85-681
GSK Investigational Site
Bydgoszcz, 85-863
GSK Investigational Site
Chełmża, 87-140
GSK Investigational Site
Chodzież, 64-800
GSK Investigational Site
Chorzów, 41-500
GSK Investigational Site
Choszczno, 73-200
GSK Investigational Site
Częstochowa, 42-200
GSK Investigational Site
Dąbrowa Górnicza, 41-300
GSK Investigational Site
Działdowo, 13-200
GSK Investigational Site
Elblag, 82-300
GSK Investigational Site
Gdansk, 80-286
GSK Investigational Site
Gdansk, 80-405
GSK Investigational Site
Gdansk, 80-433
GSK Investigational Site
Gdynia, 81-384
GSK Investigational Site
Gorzów Wielkopolski, 66-400
GSK Investigational Site
Grudziądz, 86-300
GSK Investigational Site
Iława, 14-200
GSK Investigational Site
Inowrocław, 88-100
GSK Investigational Site
Izabelin, 05-080
GSK Investigational Site
Jelenia Góra, 58-506
GSK Investigational Site
Karpacz, 58-540
GSK Investigational Site
Katowice, 40-040
GSK Investigational Site
Katowice, 40-954
GSK Investigational Site
Kielce, 25-030
GSK Investigational Site
Kielce, 25-365
GSK Investigational Site
Kielce, 25-734
GSK Investigational Site
Krakow, 31-024
GSK Investigational Site
Krakow, 31-455
GSK Investigational Site
Krakow, 31-530
GSK Investigational Site
Krakow, 31-567
GSK Investigational Site
Krakow, 31-637
GSK Investigational Site
Krakow, 31-913
GSK Investigational Site
Krotoszyn, 63-700
GSK Investigational Site
Ksawerów, 95-054
GSK Investigational Site
Kutno, 99-300
GSK Investigational Site
Łęczyca, 99-100
GSK Investigational Site
Libiąż, 32-590
GSK Investigational Site
Lodz, 90-153
GSK Investigational Site
Lodz, 90-203
GSK Investigational Site
Lodz, 90-302
GSK Investigational Site
Lodz, 90-430
GSK Investigational Site
Lodz, 91-849
GSK Investigational Site
Lodz, 92-107
GSK Investigational Site
Lodz, 92-215
GSK Investigational Site
Lodz, 93-113
GSK Investigational Site
Lodz, 93-329
GSK Investigational Site
Lodz, 94-050
GSK Investigational Site
Lublin, 20-093
GSK Investigational Site
Lublin, 20-552
GSK Investigational Site
Lublin, 20-718
GSK Investigational Site
Oława, 55-200
GSK Investigational Site
Olsztyn, 10-357
GSK Investigational Site
Ostrow Wilekopolski, 63-400
GSK Investigational Site
Ostrowiec Świętokrzyski, 27-400
GSK Investigational Site
Piaseczno, 05-500
GSK Investigational Site
Piła, 64-920
GSK Investigational Site
Płock, 09-402
GSK Investigational Site
Police, 72-010
GSK Investigational Site
Poznan, 60-214
GSK Investigational Site
Poznan, 60-569
GSK Investigational Site
Poznan, 60-773
GSK Investigational Site
Poznan, 60-823
GSK Investigational Site
Ruda Śląska, 41-709
GSK Investigational Site
Rudka, 05-320
GSK Investigational Site
Rzeszów, 35-301
GSK Investigational Site
Skarżysko-Kamienna, 26-110
GSK Investigational Site
Skierniewice, 96-100
GSK Investigational Site
Słupsk, 76-200
GSK Investigational Site
Sopot, 81- 717
GSK Investigational Site
Świdnik, 21-040
GSK Investigational Site
Szczecin, 70-111
GSK Investigational Site
Szczecin, 71-124
GSK Investigational Site
Tarnów, 33-100
GSK Investigational Site
Tczew, 83-110
GSK Investigational Site
Torun, 87100
GSK Investigational Site
Warsaw, 01-138
GSK Investigational Site
Warsaw, 01-157
GSK Investigational Site
Warsaw, 01-192
GSK Investigational Site
Warsaw, 01-868
GSK Investigational Site
Włocławek, 87-800
GSK Investigational Site
Włoszczowa, 29-100
GSK Investigational Site
Wodzisław Śląski, 44-300
GSK Investigational Site
Wroclaw, 50-044
GSK Investigational Site
Wroclaw, 50-088
GSK Investigational Site
Wroclaw, 53-301
GSK Investigational Site
Wroclaw, 53-439
GSK Investigational Site
Wroclaw, 54-239
GSK Investigational Site
Zabrze, 41-800
GSK Investigational Site
Zabrze, 41-807
GSK Investigational Site
Zgierz, 95-100
Germany80 sites
GSK Investigational Site
Aschaffenburg, Bavaria, 63739
GSK Investigational Site
Augsburg, Bavaria, 86150
GSK Investigational Site
Augsburg, Bavaria, 86156
GSK Investigational Site
Bad Woerrishofen, Bavaria, 86825
GSK Investigational Site
Bensheim, Hesse, 64625
GSK Investigational Site
Bergisch Gladbach, North Rhine-Westphalia, 51429
GSK Investigational Site
Berlin, 10717
GSK Investigational Site
Berlin, 10787
GSK Investigational Site
Berlin, 10789
GSK Investigational Site
Berlin, 10969
GSK Investigational Site
Berlin, 12043
GSK Investigational Site
Berlin, 12099
GSK Investigational Site
Berlin, 12165
GSK Investigational Site
Berlin, 12203
GSK Investigational Site
Berlin, 12627
GSK Investigational Site
Berlin, 12687
GSK Investigational Site
Berlin, 13086
GSK Investigational Site
Berlin, 13125
GSK Investigational Site
Berlin, 13156
GSK Investigational Site
Berlin, 13507
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44787
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53119
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53123
GSK Investigational Site
Bruchsal, Baden-Wurttemberg, 76646
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51069
GSK Investigational Site
Cottbus, Brandenburg, 03050
GSK Investigational Site
Darmstadt, Hesse, 64287
GSK Investigational Site
Deggingen, Baden-Wurttemberg, 73326
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44263
GSK Investigational Site
Dresden, Saxony, 01067
GSK Investigational Site
Dresden, Saxony, 01307
GSK Investigational Site
Düren, North Rhine-Westphalia, 52349
GSK Investigational Site
Essen, North Rhine-Westphalia, 45136
GSK Investigational Site
Essen, North Rhine-Westphalia, 45355
GSK Investigational Site
Ettlingen, Baden-Wurttemberg, 76275
GSK Investigational Site
Feldkirchen, Bavaria, 83620
GSK Investigational Site
Föhren, Rhineland-Palatinate, 54343
GSK Investigational Site
Frankfurt, Baden-Wurttemberg, 60596
GSK Investigational Site
Fürth, Bavaria, 90762
GSK Investigational Site
Gauting, Bavaria, 82131
GSK Investigational Site
Gelsenkirchen, North Rhine-Westphalia, 45879
GSK Investigational Site
Görlitz, Saxony, 02826
GSK Investigational Site
Göttingen, Lower Saxony, 37081
GSK Investigational Site
Hagen, North Rhine-Westphalia, 58089
GSK Investigational Site
Hagen, North Rhine-Westphalia, 58095
GSK Investigational Site
Hamburg, 22291
GSK Investigational Site
Hamburg, 22763
GSK Investigational Site
Hanover, Lower Saxony, 30159
GSK Investigational Site
Harsewinkel, North Rhine-Westphalia, 33428
GSK Investigational Site
Höchstadt an der Aisch, Bavaria, 91315
GSK Investigational Site
Ingelheim, Rhineland-Palatinate, 55218
GSK Investigational Site
Jena, Thuringia, 07740
GSK Investigational Site
Karlsruhe, Baden-Wurttemberg, 76227
GSK Investigational Site
Kassel, Hesse, 34121
GSK Investigational Site
Landsberg am Lech, Bavaria, 86899
GSK Investigational Site
Leipzg, Saxony, 04109
GSK Investigational Site
Leipzig, Saxony, 04103
GSK Investigational Site
Leipzig, Saxony, 04157
GSK Investigational Site
Leipzig, Saxony, 04275
GSK Investigational Site
Leipzig, Saxony, 04357
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39104
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116
GSK Investigational Site
Marburg, Hesse, 35037
GSK Investigational Site
München, 81677
GSK Investigational Site
Munich, Bavaria, 80335
GSK Investigational Site
Neuss, North Rhine-Westphalia, 41462
GSK Investigational Site
Neuwied, Rhineland-Palatinate, 56564
GSK Investigational Site
Papenburg, Lower Saxony, 26871
GSK Investigational Site
Potsdam, Brandenburg, 14478
GSK Investigational Site
Reinfeld, Schleswig-Holstein, 23858
GSK Investigational Site
Rhaunen, Rhineland-Palatinate, 55624
GSK Investigational Site
Riesa, Saxony, 01587
GSK Investigational Site
Rüdersdorf, Brandenburg, 15562
GSK Investigational Site
Schleswig, Schleswig-Holstein, 24837
GSK Investigational Site
Solingen, North Rhine-Westphalia, 42651
GSK Investigational Site
Stuhr, Lower Saxony, 28816
GSK Investigational Site
Vilshofen, Bavaria, 94474
GSK Investigational Site
Wardenburg, Lower Saxony, 26203
GSK Investigational Site
Weißenhorn, Bavaria, 89264
GSK Investigational Site
Zerbst, Saxony-Anhalt, 39261
Argentina69 sites
GSK Investigational Site
Adrogué, Buenos Aires, B1846DSK
GSK Investigational Site
Bahía Blanca, Buenos Aires, B8000FTD
GSK Investigational Site
Buenos Aires, B1704ETD
GSK Investigational Site
Buenos Aires, C1061ABD
GSK Investigational Site
Buenos Aires, C1120AAC
GSK Investigational Site
Buenos Aires, C1280AEB
GSK Investigational Site
Buenos Aires, C1407HUF
GSK Investigational Site
Buenos Aires, C1425AGC
GSK Investigational Site
Buenos Aires, C1425BEN
GSK Investigational Site
Buenos Aires, C1425FVH
GSK Investigational Site
Buenos Aires, C1426ABP
GSK Investigational Site
Buenos Aires, C1437BZ
GSK Investigational Site
Cipoletti, Rio Negro, Río Negro Province, R8324CVE
GSK Investigational Site
Ciudad Autnónoma de Buenos Aires, Buenos Aires, C1186ACB
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1028AAP
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1122AAK
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BCH
GSK Investigational Site
Concepción del Uruguay, Entre Ríos Province, 3260
GSK Investigational Site
Córdoba, Córdoba Province, X5000AAW
GSK Investigational Site
Córdoba, Córdoba Province, X5003DCE
GSK Investigational Site
Córdoba, 5000
GSK Investigational Site
Córdoba, 5016
GSK Investigational Site
Córdoba, 5900
GSK Investigational Site
Córdoba, X5003DCE
GSK Investigational Site
Córdoba, X5004BAL
GSK Investigational Site
Córdoba, X5006
GSK Investigational Site
Coronel Suárez, 7540
GSK Investigational Site
Corrientes, W3400AVK
GSK Investigational Site
Derqui, Pilar, Buenos Aires, B1629AHJ
GSK Investigational Site
Formosa, 3600
GSK Investigational Site
Godoy Cruz, Mendoza Province, 5501
GSK Investigational Site
La Plata, Buenos Aires, 1900
GSK Investigational Site
La Plata, Buenos Aires, B1900AXI
GSK Investigational Site
Lanus, B1824KAJ
GSK Investigational Site
Mar del Plata, Buenos Aires, B7600FZN
GSK Investigational Site
Mar del Plata, B7600FYK
GSK Investigational Site
Mendoza, 5500
GSK Investigational Site
Mendoza, M5500CCG
GSK Investigational Site
Mendoza, MM5500
GSK Investigational Site
Monte Grande, 1842
GSK Investigational Site
Nueve de Julio, Buenos Aires, B6500BWQ
GSK Investigational Site
Olivos, Buenos Aires, B1605DSX
GSK Investigational Site
Paraná, Entre Ríos Province, E3100BHK
GSK Investigational Site
Pergamino, Buenos Aires, B2700CPM
GSK Investigational Site
Quilmes, Buenos Aires, 1878
GSK Investigational Site
Quilmes, Buenos Aires, B1878FNR
GSK Investigational Site
Rosario, Santa Fe Province, 2000
GSK Investigational Site
Rosario, Santa Fe Province, S2000BIF
GSK Investigational Site
Rosario, Santa Fe Province, S2000CVD
GSK Investigational Site
Rosario, Santa Fe Province, S2002OJN
GSK Investigational Site
Rosario, Santa Fe Province, S2005PAF
GSK Investigational Site
Rosario, 2000
GSK Investigational Site
Rosario, S2000CXP
GSK Investigational Site
Salta, A4400ANG
GSK Investigational Site
Salta, A4400ERH
GSK Investigational Site
San Isidro, Buenos Aires, B1642DCD
GSK Investigational Site
San Juan Bautista, Buenos Aires, 1888
GSK Investigational Site
San Juan Bautista, C1073ABA
GSK Investigational Site
San Luis, 5700
GSK Investigational Site
San Martín, Buenos Aires, 1650
GSK Investigational Site
San Miguel de Tucumán, Tucumán Province, 4000
GSK Investigational Site
San Miguel de Tucumán, 4000
GSK Investigational Site
San Nicolás de los Arroyos, Buenos Aires, B2900DMH
GSK Investigational Site
San Nicolás de los Arroyos, Buenos Aires, B2900IIC
GSK Investigational Site
San Salvador de Jujuy, 4600
GSK Investigational Site
Santa Fe, 3000
GSK Investigational Site
Santa Fe, 3016
GSK Investigational Site
Santiago del Estero
GSK Investigational Site
Vicente López, Buenos Aires, 1602
Ukraine67 sites
GSK Investigational Site
Alupka, 98676
GSK Investigational Site
Cherkassy, 18009
GSK Investigational Site
Chernihiv, 14034
GSK Investigational Site
Chernivtsi, 58022
GSK Investigational Site
Dnipropetrovsk, 49005
GSK Investigational Site
Dnipropetrovsk, 49027
GSK Investigational Site
Dnipropetrovsk, 49064
GSK Investigational Site
Dnipropetrovsk, 49074
GSK Investigational Site
Dnipropetrovsk, 49102
GSK Investigational Site
Donetsk, 83003
GSK Investigational Site
Donetsk, 83045
GSK Investigational Site
Donetsk, 83059
GSK Investigational Site
Donetsk, 83114
GSK Investigational Site
Ivano-Frankivsk, 76005
GSK Investigational Site
Ivano-Frankivsk, 76008
GSK Investigational Site
Ivano-Frankivsk, 76018
GSK Investigational Site
Kharkiv, 61001
GSK Investigational Site
Kharkiv, 61002
GSK Investigational Site
Kharkiv, 61018
GSK Investigational Site
Kharkiv, 61022
GSK Investigational Site
Kharkiv, 61039
GSK Investigational Site
Kharkiv, 61046
GSK Investigational Site
Kharkiv, 61103
GSK Investigational Site
Kharkiv, 61124
GSK Investigational Site
Kharkiv, 61157
GSK Investigational Site
Kherson, 73000
GSK Investigational Site
Kiev, 02660
GSK Investigational Site
Kiev, 03680
GSK Investigational Site
Kryvyi Rig, 50096
GSK Investigational Site
Kyiv, 03038
GSK Investigational Site
Kyiv, 03049
GSK Investigational Site
Kyiv, 03179
GSK Investigational Site
Kyiv, 03680
GSK Investigational Site
Kyiv, 04114
GSK Investigational Site
Kyiv, 04201
GSK Investigational Site
Kyiv, 1680
GSK Investigational Site
Kyiv, 4050
GSK Investigational Site
Kyiv, 4107
GSK Investigational Site
Lutsk, 43024
GSK Investigational Site
Lviv, 79010
GSK Investigational Site
Lviv, 79015
GSK Investigational Site
Mykolaiv, 54003
GSK Investigational Site
Odesa, 65009
GSK Investigational Site
Odesa, 65010
GSK Investigational Site
Odesa, 65025
GSK Investigational Site
Odesa, 65114
GSK Investigational Site
Poltava, 36024
GSK Investigational Site
Poltava, 36028
GSK Investigational Site
Poltava, 36038
GSK Investigational Site
Simferopol, 95043
GSK Investigational Site
Sumy, 40022
GSK Investigational Site
Sumy, 40030
GSK Investigational Site
Sympheropol, 95017
GSK Investigational Site
Ternopil, 46002
GSK Investigational Site
Uzhhorod, 88000
GSK Investigational Site
Uzhhorod, 88009
GSK Investigational Site
Uzhhorod, 88017
GSK Investigational Site
Vinnytsia, 21001
GSK Investigational Site
Vinnytsia, 21018
GSK Investigational Site
Vinnytsia, 21029
GSK Investigational Site
Yalta, 98603
GSK Investigational Site
Zaporizhia, 69035
GSK Investigational Site
Zaporizhzhya, 69001
GSK Investigational Site
Zaporizhzhya, 69106
GSK Investigational Site
Zaporizhzhya, 69118
GSK Investigational Site
Zaporizhzhya, 69600
GSK Investigational Site
Zhytomyr, 10002
China50 sites
GSK Investigational Site
Baotou, Inner Mongolia, 014010
GSK Investigational Site
Baotou
GSK Investigational Site
Beijing, 100020
GSK Investigational Site
Beijing, 100029
GSK Investigational Site
Beijing, 100050
GSK Investigational Site
Beijing, 100070
GSK Investigational Site
Beijing, 100144
GSK Investigational Site
Bengbu, 233000
GSK Investigational Site
Changchun, 130012
GSK Investigational Site
Chengdu, Sichuan, 610083
GSK Investigational Site
Chengdu, 610041
GSK Investigational Site
Chongqing, 400016
GSK Investigational Site
Chongqing, 400038
GSK Investigational Site
Chongqing, 400042
GSK Investigational Site
Fuzhou, 350025
GSK Investigational Site
Fuzhou
GSK Investigational Site
Guangxi, 530021
GSK Investigational Site
Guangzhou, Guangdong, 510080
GSK Investigational Site
Guangzhou, Guangdong, 510120
GSK Investigational Site
Guangzhou, Guangdong, 510515
GSK Investigational Site
Guangzhou, 510080
GSK Investigational Site
Haikou, Hainan, 570001
GSK Investigational Site
Haikou, Hainan, 570311
GSK Investigational Site
Hangzhou, 310014
GSK Investigational Site
Hefei, 230001
GSK Investigational Site
Hohhot, Hainan, 010050
GSK Investigational Site
Huai'an, 223300
GSK Investigational Site
Jiangyin
GSK Investigational Site
Jinan, Shandong, 250033
GSK Investigational Site
Luzhou
GSK Investigational Site
Nanchang, 330006
GSK Investigational Site
Nanjing, 210009
GSK Investigational Site
Nanning, Guangxi, 530021
GSK Investigational Site
Shanghai, 200003
GSK Investigational Site
Shanghai, 200025
GSK Investigational Site
Shanghai, 200032
GSK Investigational Site
Shanghai, 200040
GSK Investigational Site
Shanghai, 200062
GSK Investigational Site
Shanghai, 200072
GSK Investigational Site
Shanghai, 200433
GSK Investigational Site
Shenyang, Liaoning, 110004
GSK Investigational Site
Shenzhen, Guangdong, 518020
GSK Investigational Site
Shijiazhuang, Hebei, 050000
GSK Investigational Site
Taiyuan, Shanxi, 030001
GSK Investigational Site
Tianjin, 300121
GSK Investigational Site
Wuhan, Hubei, 430060
GSK Investigational Site
Wuxi, 214023
GSK Investigational Site
Xi'an, Shaanxi, 710032
GSK Investigational Site
Yinchuan, Ningxia, 750004
GSK Investigational Site
Zhanjiang, Guangdong, 524001
Romania38 sites
GSK Investigational Site
Arad, 310013
GSK Investigational Site
Bacau, 600252
GSK Investigational Site
Bragadiru, 077025
GSK Investigational Site
Brasov, 500086
GSK Investigational Site
Brasov, 500283
GSK Investigational Site
Bucharest, 011025
GSK Investigational Site
Bucharest, 011794
GSK Investigational Site
Bucharest, 012384
GSK Investigational Site
Bucharest, 014461
GSK Investigational Site
Bucharest, 020125
GSK Investigational Site
Bucharest, 020475
GSK Investigational Site
Bucharest, 021659
GSK Investigational Site
Bucharest, 022328
GSK Investigational Site
Bucharest, 030303
GSK Investigational Site
Bucharest, 040206
GSK Investigational Site
Bucharest, 050159
GSK Investigational Site
Bucharest, 050554
GSK Investigational Site
Bucharest, 050722
GSK Investigational Site
Bucharest, 10825
GSK Investigational Site
Campulung Muscel, 115100
GSK Investigational Site
Cluj-Napoca, 400352
GSK Investigational Site
Cluj-Napoca, 400371
GSK Investigational Site
Codlea, 505100
GSK Investigational Site
Constanța, 900002
GSK Investigational Site
Constanța, 900004
GSK Investigational Site
Deva, 330084
GSK Investigational Site
Iași, 700141
GSK Investigational Site
Iași, 700381
GSK Investigational Site
Iași, 700503
GSK Investigational Site
Iași, 700656
GSK Investigational Site
Piteşti, 110084
GSK Investigational Site
Piteşti, 110283
GSK Investigational Site
Ploieşti, 100184
GSK Investigational Site
Râmnicu Vâlcea, 240564
GSK Investigational Site
Suceava, 720284
GSK Investigational Site
Târgu Mureş, 540142
GSK Investigational Site
Timișoara, 300310
GSK Investigational Site
Timișoara, 300736
Czechia37 sites
GSK Investigational Site
Benešov, 256 01
GSK Investigational Site
Beroun, 266 01
GSK Investigational Site
Brno, 612 00
GSK Investigational Site
Havlíčkův Brod, 580 01
GSK Investigational Site
Hlučín, 748 01
GSK Investigational Site
Holešov, 769 01
GSK Investigational Site
Jaroměř, 551 01
GSK Investigational Site
Jindřichův Hradec, 377 01
GSK Investigational Site
Kolín, 280 00
GSK Investigational Site
Kralupy nad Vltavou, 278 01
GSK Investigational Site
Kroměříž, 767 01
GSK Investigational Site
Liberec, 460 01
GSK Investigational Site
Mělník, 276 01
GSK Investigational Site
Moravský Krumlov, 672 01
GSK Investigational Site
Neratovice, 277 11
GSK Investigational Site
Nový Jičín, 741 01
GSK Investigational Site
Ostrava, 72880
GSK Investigational Site
Ostrava - Belsky Les, 700 30
GSK Investigational Site
Ostrava - Poruba, 70868
GSK Investigational Site
Pilsen, 301 00
GSK Investigational Site
Pilsen, 323 00
GSK Investigational Site
Prague, 110 00
GSK Investigational Site
Prague, 130 00
GSK Investigational Site
Prague, 140 00
GSK Investigational Site
Prague, 140 46
GSK Investigational Site
Prague, 150 00
GSK Investigational Site
Prague, 158 00
GSK Investigational Site
Prague, 163 00
GSK Investigational Site
Prague, 169 00
GSK Investigational Site
Rokycany, 337 01
GSK Investigational Site
Rudná, 252 19
GSK Investigational Site
Strakonice, 386 01
GSK Investigational Site
Strakonice, 386 29
GSK Investigational Site
Svitavy, 568 25
GSK Investigational Site
Třemošná, 330 11
GSK Investigational Site
Usti Nad Labem - Klise, 400 01
GSK Investigational Site
Žatec, 438 01
South Africa37 sites
GSK Investigational Site
Benoni, Gauteng, 1501
GSK Investigational Site
Benoni, 1501
GSK Investigational Site
Bloemfontein, 9301
GSK Investigational Site
Boksburg, Gauteng, 1459
GSK Investigational Site
Cape Town, 7441
GSK Investigational Site
Cape Town, 7500
GSK Investigational Site
Cape Town, 7572
GSK Investigational Site
Cape Town, 7700
GSK Investigational Site
Cape Town, 8001
GSK Investigational Site
CapeTown, 7764
GSK Investigational Site
Dundee, KwaZulu-Natal, 3000
GSK Investigational Site
Durban, 4001
GSK Investigational Site
Durban, 4071
GSK Investigational Site
Gatesville, 7764
GSK Investigational Site
Johannesburg, 1686
GSK Investigational Site
Korsten, 6014
GSK Investigational Site
Lynnwood Ridge, 0014
GSK Investigational Site
Meyerspark, Gauteng, 0184
GSK Investigational Site
Middelburg, Mpumalanga, 1055
GSK Investigational Site
Morningside, Gauteng, 2057
GSK Investigational Site
Mowbray, 7700
GSK Investigational Site
Paarl, 7646
GSK Investigational Site
Panorama, 7500
GSK Investigational Site
Potchefstroom, 2531
GSK Investigational Site
Pretoria, Gauteng, 0041
GSK Investigational Site
Pretoria, Gauteng, 0084
GSK Investigational Site
Pretoria, Gauteng, 0181
GSK Investigational Site
Pretoria, Gauteng, 0183
GSK Investigational Site
Pretoria, 0002
GSK Investigational Site
Pretoria, 0022
GSK Investigational Site
Roodepoort, 1724
GSK Investigational Site
Rooihuiskraal, 158
GSK Investigational Site
Somerset West, 7130
GSK Investigational Site
Thaba Tshwane, Gauteng, 0143
GSK Investigational Site
Thabazimbi, 0380
GSK Investigational Site
Tygerberg, 7505
GSK Investigational Site
Voorspoed, 9459
South Korea35 sites
GSK Investigational Site
Bucheon-si, 420-717
GSK Investigational Site
Bucheon-Si, Gyeonggi-Do, 420-021
GSK Investigational Site
Busan, 602-715
GSK Investigational Site
Cheonan, 330-721
GSK Investigational Site
Chonju-si, 561-712
GSK Investigational Site
Daegu, 705-717
GSK Investigational Site
Daejeon, 301-721
GSK Investigational Site
Daejeon, 301-723
GSK Investigational Site
Goyang-si, 411706
GSK Investigational Site
Guri-si, 471-701
GSK Investigational Site
Gwangju, 501-757
GSK Investigational Site
Gyeonggi-do, 410-719
GSK Investigational Site
Incheon, 400-711
GSK Investigational Site
Incheon, 403-720
GSK Investigational Site
Kangwon, 200-722
GSK Investigational Site
Seongnam, 463-712
GSK Investigational Site
Seoul, 100-030
GSK Investigational Site
Seoul, 110-746
GSK Investigational Site
Seoul, 130-709
GSK Investigational Site
Seoul, 130-872
GSK Investigational Site
Seoul, 133--792
GSK Investigational Site
Seoul, 135-720
GSK Investigational Site
Seoul, 136-705
GSK Investigational Site
Seoul, 139-707
GSK Investigational Site
Seoul, 139-711
GSK Investigational Site
Seoul, 140-887
GSK Investigational Site
Seoul, 150-713
GSK Investigational Site
Seoul, 152-703
GSK Investigational Site
Seoul, 158-710
GSK Investigational Site
Seoul, 380-704
GSK Investigational Site
Seoul
GSK Investigational Site
Suwon, Gyeonggi-do, 442-723
GSK Investigational Site
Uijeongbu, Gyeonggi-do, 480-717
GSK Investigational Site
Ulsan, 682-714
GSK Investigational Site
Wonju-si, Kanwon-do, 220-701
India31 sites
GSK Investigational Site
Ahmedabad, 380007
GSK Investigational Site
Ahmedabad, 380052
GSK Investigational Site
Alappuzha, 688524
GSK Investigational Site
Angamaly, 683 572
GSK Investigational Site
Bangalore, 560 010
GSK Investigational Site
Bangalore, 560 054
GSK Investigational Site
Bangalore, 560034
GSK Investigational Site
Bangalore, 560076
GSK Investigational Site
Chennai, 600034
GSK Investigational Site
Chennai, 600100
GSK Investigational Site
Chhatrapati Sambhajinagar, 431001
GSK Investigational Site
Guntur, 522001
GSK Investigational Site
Hyderabad, 500004
GSK Investigational Site
Hyderabad, 500035
GSK Investigational Site
Hyderabad, 500038
GSK Investigational Site
Jaipur, 302006
GSK Investigational Site
Jaipur, 302022
GSK Investigational Site
Lucknow, 226018
GSK Investigational Site
Mysore, 570002
GSK Investigational Site
Mysore, 570004
GSK Investigational Site
Nagpur, 440012
GSK Investigational Site
Nagpur, 440019
GSK Investigational Site
Nashik, 422005
GSK Investigational Site
Nashik, 422007
GSK Investigational Site
Pune, 411014
GSK Investigational Site
Pune, 411015
GSK Investigational Site
Trisshur, 680 002
GSK Investigational Site
Trivandrum, 695004
GSK Investigational Site
Varanasi, 221001
GSK Investigational Site
Varanasi, 221005
GSK Investigational Site
Vijayawada, 520002
Bulgaria29 sites
GSK Investigational Site
Blagoevgrad, 2700
GSK Investigational Site
Dimitrovgrad, 6400
GSK Investigational Site
Gabrovo, 5300
GSK Investigational Site
Kozloduy, 3320
GSK Investigational Site
Lovech, 5500
GSK Investigational Site
Pazardzhik, 4400
GSK Investigational Site
Petrich, 2850
GSK Investigational Site
Pleven, 5800
GSK Investigational Site
Plovdiv, 4002
GSK Investigational Site
Razgrad, 7200
GSK Investigational Site
Rousse, 7000
GSK Investigational Site
Sevlievo, 5400
GSK Investigational Site
Sliven, 8800
GSK Investigational Site
Sofia, 1000
GSK Investigational Site
Sofia, 1142
GSK Investigational Site
Sofia, 1202
GSK Investigational Site
Sofia, 1233
GSK Investigational Site
Sofia, 1336
GSK Investigational Site
Sofia, 1431
GSK Investigational Site
Sofia, 1505
GSK Investigational Site
Sofia, 1606
GSK Investigational Site
Sofia, 1618
GSK Investigational Site
Sofia, 1784
GSK Investigational Site
Stara Zagora, 6000
GSK Investigational Site
Stara Zagora, 6003
GSK Investigational Site
Troyan Municipality, 5600
GSK Investigational Site
Varna, 9000
GSK Investigational Site
Veliko Tarnovo, 5000
GSK Investigational Site
Vidin, 3700
Hungary26 sites
GSK Investigational Site
Balassagyarmat, 2660
GSK Investigational Site
Budapest, 1036
GSK Investigational Site
Budapest, 1101
GSK Investigational Site
Budapest, 1117
GSK Investigational Site
Budapest, 1122
GSK Investigational Site
Budapest, 1125
GSK Investigational Site
Budapest, 1134
GSK Investigational Site
Budapest, 1191
GSK Investigational Site
Budapest, 1204
GSK Investigational Site
Debrecen, 4026
GSK Investigational Site
Debrecen, 4031
GSK Investigational Site
Gyula, 5703
GSK Investigational Site
Kaposvár, 7400
GSK Investigational Site
Komárom, 2900
GSK Investigational Site
Komló, 7300
GSK Investigational Site
Mosonmagyaróvár, 9200
GSK Investigational Site
Nagykanizsa, 8800
GSK Investigational Site
Nyíregyháza, 4400
GSK Investigational Site
Pécs, 7635
GSK Investigational Site
Sopron, 9400
GSK Investigational Site
Szigetszentmiklós, 2310
GSK Investigational Site
Szikszó, H-3800
GSK Investigational Site
Szombathely, 9700
GSK Investigational Site
Tatabánya, 2800
GSK Investigational Site
Vásárosnamény, 4800
GSK Investigational Site
Zalaegerszeg, 8900
Spain26 sites
GSK Investigational Site
Badalona, 08916
GSK Investigational Site
Barcelona, 08022
GSK Investigational Site
Barcelona, 08025
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Barcelona, 08041
GSK Investigational Site
Benidorm, 03501
GSK Investigational Site
Canet de Mar - Barcelona, 08360
GSK Investigational Site
Galdakano, 48960
GSK Investigational Site
Illescas-Toledo, 45200
GSK Investigational Site
Jerez de la Frontera, 11407
GSK Investigational Site
L'Hospitalet de Llobregat, 08907
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Mataró, 08303
GSK Investigational Site
Oviedo, 33006
GSK Investigational Site
Palma de Mallorca, 07010
GSK Investigational Site
Pamplona, 31008
GSK Investigational Site
Pozuelo de Alarcón/Madrid, 28223
GSK Investigational Site
Sabadell (Barcelona), 08208
GSK Investigational Site
Sagunto/Valencia, 46520
GSK Investigational Site
Sant Boi de Llobregat, 08830
GSK Investigational Site
Santa Coloma de Gramenet, 08921
GSK Investigational Site
Santiago de Compostela, 15706
GSK Investigational Site
Torrelavega, 39300
GSK Investigational Site
Valencia, 46017
GSK Investigational Site
Vic (Barcelona), 08500
Croatia25 sites
GSK Investigational Site
Čakovec, 40000
GSK Investigational Site
Draganići, 47201
GSK Investigational Site
Hrašće Turopoljsko, 10020
GSK Investigational Site
Hreljin, 51226
GSK Investigational Site
Ivankovo, 32281
GSK Investigational Site
Karlovac, 47000
GSK Investigational Site
Klenovnik, 42244
GSK Investigational Site
Krapina, 49000
GSK Investigational Site
Kutina, 44320
GSK Investigational Site
Novi Marof, 42220
GSK Investigational Site
Osijek, 31000
GSK Investigational Site
Retkovci, 32282
GSK Investigational Site
Rijeka, 51000
GSK Investigational Site
Samobor, 10430
GSK Investigational Site
Senj, 53270
GSK Investigational Site
Šibenik, 22000
GSK Investigational Site
Sisak, 44000
GSK Investigational Site
Split, 21000
GSK Investigational Site
Strmec, 10434
GSK Investigational Site
Stubičke Toplice, 49244
GSK Investigational Site
Sukosan, 23206
GSK Investigational Site
Varaždin, 42000
GSK Investigational Site
Zabok, 49210
GSK Investigational Site
Zadar, 23000
GSK Investigational Site
Zagreb, 10000
United Kingdom25 sites
GSK Investigational Site
Bedford, Bedfordshire, MK404AW
GSK Investigational Site
Bedford, Bedfordshire, MK42 9DJ
GSK Investigational Site
Bexhill-on-Sea, TN40 1JJ
GSK Investigational Site
Birmingham, B9 5SS
GSK Investigational Site
Brighton, BN2 5BE
GSK Investigational Site
Buckshaw Village, Chorley, Lancashire, PR7 7NA
GSK Investigational Site
Bury St Edmunds, Suffolk, IP30 9QU
GSK Investigational Site
Cardiff, CF14 5GJ
GSK Investigational Site
Chelmsford, CM1 7ET
GSK Investigational Site
Chesterfield, Derbyshire, S40 4AA
GSK Investigational Site
Derby, DE22 3NE
GSK Investigational Site
Edgbaston, Birmingham, B15 2SQ
GSK Investigational Site
Edinburgh, EH16 4SA
GSK Investigational Site
Glasgow, G20 0SP
GSK Investigational Site
Liverpool, Merseyside, L9 7AL
GSK Investigational Site
London, EC1M 6BQ
GSK Investigational Site
Manchester, M15 6SX
GSK Investigational Site
Milton Keynes, MK6 5LD
GSK Investigational Site
Northwood, Middlesex, HA6 2RN
GSK Investigational Site
Peterborough, Cambridgeshire, PE8 6PL
GSK Investigational Site
Reading, RG2 0TG
GSK Investigational Site
Sidcup, Kent, DA14 6LT
GSK Investigational Site
Soham, Cambridgeshire, CB7 5JD
GSK Investigational Site
Tyne and Wear, NE29 8NH
GSK Investigational Site
Waterloo, Liverpool, Merseyside, L22 0LG
Bosnia and Herzegovina23 sites
GSK Investigational Site
Banja Luka, 78000
GSK Investigational Site
Bihać, 77 000
GSK Investigational Site
Bihać, 77000
GSK Investigational Site
Bijeljina, 76300
GSK Investigational Site
Brčko, 76000
GSK Investigational Site
Foca, 73300
GSK Investigational Site
Gračanica, 75320
GSK Investigational Site
Gradiska, 78400
GSK Investigational Site
Istocno Sarajevo, 71123
GSK Investigational Site
Konjic, 88400
GSK Investigational Site
Mostar, 88000
GSK Investigational Site
Novi Travnik
GSK Investigational Site
Pale, 71420
GSK Investigational Site
Sarajevo, 71000
GSK Investigational Site
Sarajevo, 71320
GSK Investigational Site
Srebrenik, 75350
GSK Investigational Site
Tešanj, 74260
GSK Investigational Site
Teslic, 74270
GSK Investigational Site
Travnik, 72270
GSK Investigational Site
Trebinje, 89101
GSK Investigational Site
Tuzla, 75000
GSK Investigational Site
Višegrad, 73240
GSK Investigational Site
Zenica, 72000
Japan23 sites
GSK Investigational Site
Aichi, 454-8502
GSK Investigational Site
Aichi, 457-8510
GSK Investigational Site
Aichi, 457-8511
GSK Investigational Site
Fukuoka, 832-0059
GSK Investigational Site
Gifu, 500-8717
GSK Investigational Site
Hokkaido, 053-8506
GSK Investigational Site
Hokkaido, 060-0033
GSK Investigational Site
Hokkaido, 070-8644
GSK Investigational Site
Hyōgo, 650-0047
GSK Investigational Site
Ibaraki, 319-1113
GSK Investigational Site
Kagawa, 762-0031
GSK Investigational Site
Kodaira, 187-0002
GSK Investigational Site
Kumamoto, 861-1196
GSK Investigational Site
Kyoto, 607-8062
GSK Investigational Site
Ōita, 876-0047
GSK Investigational Site
Osaka, 530-0001
GSK Investigational Site
Osaka, 558-8558
GSK Investigational Site
Osaka, 591-8555
GSK Investigational Site
Shimane, 690-8509
GSK Investigational Site
Shimane, 690-8556
GSK Investigational Site
Tokyo, 103-0027
GSK Investigational Site
Tokyo, 103-0028
GSK Investigational Site
Tokyo, 194-0023
Canada22 sites
GSK Investigational Site
Bolton, Ontario, L7E 4C8
GSK Investigational Site
Burlington, Ontario, L7N 3V2
GSK Investigational Site
Edmonton, Alberta, T5A 4L8
GSK Investigational Site
Edmonton, Alberta, T5J 3S9
GSK Investigational Site
Grimsby, Ontario, L3M 1P3
GSK Investigational Site
Kamloops, British Columbia, V2C 1K7
GSK Investigational Site
London, Ontario, N5Y 5K7
GSK Investigational Site
Mirabel, Quebec, J7J 2K8
GSK Investigational Site
Mississauga, Ontario, L4T 4J2
GSK Investigational Site
Mississauga, Ontario, L5M 2V8
GSK Investigational Site
Montreal, Quebec, H2W1T8
GSK Investigational Site
Newmarket, Ontario, L3Y 5G8
GSK Investigational Site
Orléans, Ontario, K4A 5E6
GSK Investigational Site
Penticton, British Columbia, V2A 5C8
GSK Investigational Site
Québec, Quebec, G1G 4A2
GSK Investigational Site
Sainte Jerome, Quebec, J7Z 5T3
GSK Investigational Site
Sarnia, Ontario, N7T 4X3
GSK Investigational Site
Toronto, Ontario, M5T 3A9
GSK Investigational Site
Vancouver, British Columbia, V5Z 4E1
GSK Investigational Site
West Vancouver, British Columbia, V7T 2Z3
GSK Investigational Site
Windsor, Ontario, N8X 5A6
GSK Investigational Site
Winnipeg, Manitoba, R3H 2A6
Indonesia22 sites
GSK Investigational Site
Banda Aceh, 23126
GSK Investigational Site
Banjarmasin, 70233
GSK Investigational Site
Bukittinggi, 26117
GSK Investigational Site
Denpasar, 80114
GSK Investigational Site
Depok Timur, 16411
GSK Investigational Site
Jakarta, 12430
GSK Investigational Site
Jakarta, 13230
GSK Investigational Site
Jakarta, 13630
GSK Investigational Site
Lampung Selatan, 35373
GSK Investigational Site
Makassar, 90245
GSK Investigational Site
Malang, 65100
GSK Investigational Site
Medan, 20111
GSK Investigational Site
Medan, 20154
GSK Investigational Site
Padang, 25127
GSK Investigational Site
Palembang, 30126
GSK Investigational Site
Pekanbaru, 28133
GSK Investigational Site
Pontianak, 78122
GSK Investigational Site
Pringsewu, 35373
GSK Investigational Site
Semarang, 50242
GSK Investigational Site
Surabaya, 60286
GSK Investigational Site
Surakarta, 57126
GSK Investigational Site
Yogyakarta, 55283
Philippines20 sites
GSK Investigational Site
Alabang, Muntinlupa City, 1780
GSK Investigational Site
Caloocan, 1400
GSK Investigational Site
Cavite, 4114
GSK Investigational Site
Cebu City, 6000
GSK Investigational Site
Dasmariñas, Cavite, 4114
GSK Investigational Site
Davao City, 8000
GSK Investigational Site
Iloilo City, 5000
GSK Investigational Site
Jaro, Iloilo City, 5000
GSK Investigational Site
Los Baños, 4030
GSK Investigational Site
Manila, 1000
GSK Investigational Site
Manila, 1012
GSK Investigational Site
Marilao, Bulacan, 3019
GSK Investigational Site
Pasay, 1300
GSK Investigational Site
Pasig, 1605
GSK Investigational Site
Quezon, 1104
GSK Investigational Site
Quezon City, 1100
GSK Investigational Site
Quezon City, 1102
GSK Investigational Site
Quezon City, 1108
GSK Investigational Site
Quezon City, 1109
GSK Investigational Site
San Fernando, Pampanga, 2000
Latvia19 sites
GSK Investigational Site
Balvi, LV - 4501
GSK Investigational Site
Daugavpils, LA-5403
GSK Investigational Site
Daugavpils, LV5410
GSK Investigational Site
Jēkabpils, LV 5201
GSK Investigational Site
Jelgava, LV - 3001
GSK Investigational Site
Jūrmala, LV-2010
GSK Investigational Site
Krāslava, LV - 5601
GSK Investigational Site
Kuldīga, LV - 3301
GSK Investigational Site
Liepāja, LV 3414
GSK Investigational Site
Ogre, LV - 5001
GSK Investigational Site
Riga, LV 1002
GSK Investigational Site
Riga, LV 1003
GSK Investigational Site
Riga, LV-1010
GSK Investigational Site
Riga, LV1001
GSK Investigational Site
Riga, LV1038
GSK Investigational Site
Talsi, LV - 3201
GSK Investigational Site
Tukums, LV - 3101
GSK Investigational Site
Valmiera, LV-4201
GSK Investigational Site
Ventspils, LV3601
Mexico18 sites
GSK Investigational Site
Aguascalientes, 20127
GSK Investigational Site
Chihuahua City, 31203
GSK Investigational Site
Chihuahua City, 31238
GSK Investigational Site
Cuautitlán Izcalli, State of Mexico, 54769
GSK Investigational Site
Cuernavaca, Morelos, 62350
GSK Investigational Site
Guadalajara, Jalisco, 44500
GSK Investigational Site
Guadalajara, 44670
GSK Investigational Site
Hermosillo, Sonora, 83000
GSK Investigational Site
Hidalgo, 42070
GSK Investigational Site
Mérida, 97000
GSK Investigational Site
Mexico City, 6700
GSK Investigational Site
México DF, 14050
GSK Investigational Site
Monterrey, Nuevo León, 64460
GSK Investigational Site
Monterrey, Nuevo León, 64710
GSK Investigational Site
Monterrey, 64060
GSK Investigational Site
Morelia, Michoacán, C.P. 58249
GSK Investigational Site
San Luis Potosí City, 78090
GSK Investigational Site
Zapopan, Jalisco, 45040
Taiwan18 sites
GSK Investigational Site
Changhua, 500
GSK Investigational Site
Chiayi City, 613
GSK Investigational Site
Kaohsiung City, 807
GSK Investigational Site
Kaohsiung Hsien, 833
GSK Investigational Site
Keelung, 20401
GSK Investigational Site
Linkou District, 333
GSK Investigational Site
Taichung, 40201
GSK Investigational Site
Taichung, 404
GSK Investigational Site
Taichung, 40705
GSK Investigational Site
Taichung, 433
GSK Investigational Site
Taichung, 437
GSK Investigational Site
Tainan, 704
GSK Investigational Site
Taipei, 106
GSK Investigational Site
Taipei, 115
GSK Investigational Site
Taipei, 220
GSK Investigational Site
Taipei, 235
GSK Investigational Site
Taipei
GSK Investigational Site
Yung Kang City, 71044
Georgia15 sites
GSK Investigational Site
Batumi, 6000
GSK Investigational Site
Gurjaani, 1500
GSK Investigational Site
Kutaisi, 1600
GSK Investigational Site
Kvemo Kartli, 3000
GSK Investigational Site
Tbilisi, 0101
GSK Investigational Site
Tbilisi, 0102
GSK Investigational Site
Tbilisi, 0114
GSK Investigational Site
Tbilisi, 0141
GSK Investigational Site
Tbilisi, 0144
GSK Investigational Site
Tbilisi, 0159
GSK Investigational Site
Tbilisi, 0160
GSK Investigational Site
Tbilisi, 0177
GSK Investigational Site
Tbilisi, 0186
GSK Investigational Site
Tbilisi, 0191
GSK Investigational Site
Tbilisi
Thailand14 sites
GSK Investigational Site
Bangkok, 10220
GSK Investigational Site
Bangkok, 10330
GSK Investigational Site
Bangkok, 10400
GSK Investigational Site
Bangkok, 10600
GSK Investigational Site
Bangkok, 10700
GSK Investigational Site
Chiang Mai, 50200
GSK Investigational Site
Chiangrai, 57000
GSK Investigational Site
Khon Kaen, 40002
GSK Investigational Site
Mae Rim, Chiang Mai, 50180
GSK Investigational Site
Muang, 11000
GSK Investigational Site
Nakhon Ratchasima, 30000
GSK Investigational Site
Phitsanulok, 53000
GSK Investigational Site
Phitsanulok, 65000
GSK Investigational Site
Songkhla, 90110
Turkey (Türkiye)14 sites
GSK Investigational Site
Ankara, 06280
GSK Investigational Site
Ankara, 06500
GSK Investigational Site
Ankara, 06510
GSK Investigational Site
Ankara, 06590
GSK Investigational Site
Ankara, 6030
GSK Investigational Site
Bursa, 16059
GSK Investigational Site
Istanbul, 34020
GSK Investigational Site
Istanbul, 34098
GSK Investigational Site
Istanbul, 34844
GSK Investigational Site
Istanbul, 34899
GSK Investigational Site
Istanbul, 61080
GSK Investigational Site
Kocaeli, 41380
GSK Investigational Site
Konya, 42080
GSK Investigational Site
Samsun, 55139
Slovakia13 sites
GSK Investigational Site
Bratislava, 821 06
GSK Investigational Site
Bratislava, 841 04
GSK Investigational Site
Bratislava, 841 08
GSK Investigational Site
Bratislava, 851 01
GSK Investigational Site
Košice, 040 01
GSK Investigational Site
Kráľovský Chlmec, 077 01
GSK Investigational Site
Nové Zámky, 940 01
GSK Investigational Site
Prešov, 080 01
GSK Investigational Site
Prešov, 081 81
GSK Investigational Site
Spišská Nová Ves, 052 01
GSK Investigational Site
Štúrovo, 943 01
GSK Investigational Site
Trnava, 917 01
GSK Investigational Site
Vráble, 952 01
Austria12 sites
GSK Investigational Site
Feldbach, 8330
GSK Investigational Site
Feldkirch, 6800
GSK Investigational Site
Grieskirchen, A-4710
GSK Investigational Site
Innsbruck, A-6020
GSK Investigational Site
Linz, 4020
GSK Investigational Site
Salzburg, 5020
GSK Investigational Site
Salzburg, A-5020
GSK Investigational Site
Spittal/Drau, 9800
GSK Investigational Site
Thalheim bei Wels, 4600
GSK Investigational Site
Vienna, A-1120
GSK Investigational Site
Wels, 4600
GSK Investigational Site
Zwettl Stadt, 3910
Israel12 sites
GSK Investigational Site
Afula, 18101
GSK Investigational Site
Ashkelon, 78306
GSK Investigational Site
Beersheba, 84101
GSK Investigational Site
Hadera, PO Box 169
GSK Investigational Site
Haifa, 31096
GSK Investigational Site
Haifa, 34362
GSK Investigational Site
Holon, 68125
GSK Investigational Site
Jerusalem, 91120
GSK Investigational Site
Kfar Saba, 44281
GSK Investigational Site
Rehovot, 76100
GSK Investigational Site
Tel Aviv, 64239
GSK Investigational Site
Tel HaShomer, 52621
Australia8 sites
GSK Investigational Site
Bedford Park, South Australia, 5042
GSK Investigational Site
Cairns, Queensland, 4870
GSK Investigational Site
Daw Park, South Australia, 5041
GSK Investigational Site
Footscray, Victoria, 3011
GSK Investigational Site
Geelong, Victoria, 3220
GSK Investigational Site
Glen Osmond, 5064
GSK Investigational Site
Melbourne, Victoria, 3004
GSK Investigational Site
Redcliffe, Queensland, 4020
Colombia8 sites
GSK Investigational Site
Barranquilla
GSK Investigational Site
Bogotá, 111211
GSK Investigational Site
Bogotá, 80CO
GSK Investigational Site
Bogotá
GSK Investigational Site
Cali, 571
GSK Investigational Site
Medellín, 80372
GSK Investigational Site
Medellín
GSK Investigational Site
Zipaquirá
Malaysia8 sites
GSK Investigational Site
Johor Bahru, 80100
GSK Investigational Site
Kuala Lumpur, 50590
GSK Investigational Site
Kuala Pilah, 72000
GSK Investigational Site
Kuala Selangor, 68100
GSK Investigational Site
Kuching, 93586
GSK Investigational Site
Sibu, 96000
GSK Investigational Site
Sungai Petani, Kedah, 08000
GSK Investigational Site
Taiping Perak, 34000
North Macedonia8 sites
GSK Investigational Site
Bitola, 7000
GSK Investigational Site
Gostivar, 1230
GSK Investigational Site
Ohrid, 6000
GSK Investigational Site
Prilep, 7500
GSK Investigational Site
Shtip, 2000
GSK Investigational Site
Skopje, 1000
GSK Investigational Site
Strumica, 2400
GSK Investigational Site
Veles, 1400
Serbia8 sites
GSK Investigational Site
Belgrade, 11000
GSK Investigational Site
Belgrade, 11080
GSK Investigational Site
Čačak, 32000
GSK Investigational Site
Kamenitz, 21204
GSK Investigational Site
Kragujevac, 34000
GSK Investigational Site
Niš, 18000
GSK Investigational Site
Sombor, 25000
GSK Investigational Site
Valjevo, 14000
Belarus7 sites
GSK Investigational Site
Brest, 224027
GSK Investigational Site
Grodno, 230017
GSK Investigational Site
Homyel, 246040
GSK Investigational Site
Minsk, 220030
GSK Investigational Site
Minsk, 220053
GSK Investigational Site
Minsk, 223041
GSK Investigational Site
Vitebsk, 210037
Chile6 sites
GSK Investigational Site
Santiago, Región Metro de Santiago, 7500691
GSK Investigational Site
Santiago, Región Metro de Santiago, 8910131
GSK Investigational Site
Santiago, Región Metro de Santiago
GSK Investigational Site
Temuco, Región de La Araucania, 4800798
GSK Investigational Site
Temuco, Región de La Araucania
GSK Investigational Site
Viña del Mar, Valparaiso, 2340000
Belgium5 sites
GSK Investigational Site
Diest, 3290
GSK Investigational Site
Erpent, 5101
GSK Investigational Site
Gilly, 6060
GSK Investigational Site
Mons, 7000
GSK Investigational Site
Namur, 5000
France5 sites
GSK Investigational Site
Férolles-Attilly, 77150
GSK Investigational Site
Paris, 75181
GSK Investigational Site
Strasbourg, 67091
GSK Investigational Site
Tarbes, 65013
GSK Investigational Site
Toulouse, 31059
Netherlands5 sites
GSK Investigational Site
Alkmaar, 1815 JD
GSK Investigational Site
Almelo, 7609 PP
GSK Investigational Site
Ede Gld, 6717RP
GSK Investigational Site
Helmond, 5707 HA
GSK Investigational Site
Zutphen, 7207 AE
Vietnam4 sites
GSK Investigational Site
Can Tho, 90000
GSK Investigational Site
Hà Nội, 10000
GSK Investigational Site
Ho Chi Minh City, 70000
GSK Investigational Site
Huế, 53000
Greece3 sites
GSK Investigational Site
Athens, 11527
GSK Investigational Site
Athens, 15126
GSK Investigational Site
Thessaloniki, 57010
About this study
Official title: A Clinical Outcomes Study to Compare the Effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg With Placebo on Survival in Subjects With Moderate Chronic Obstructive Pulmonary Disease (COPD) and a History of or at Increased Risk for Cardiovascular Disease
The purpose of this study is to determine if fluticasone furoate/vilanterol improves survival in patients with chronic obstructive pulmonary disease with a history of or increased risk of heart disease.
Read the detailed description
Despite a potential link between the pathogenetic mechanisms involved in Chronic Obstructive Pulmonary Disease (COPD) and atherosclerotic cardiovascular disease, there are no currently approved therapies for patients with COPD that have clearly shown an additional beneficial effect in patients with cardiovascular comorbidities. The TOwards a Revolution in COPD Health (TORCH) study assessed the impact of the inhaled corticosteroid (ICS) fluticasone propionate (FP) in combination with the long-acting beta agonist (LABA), salmeterol (SAL), in reducing all-cause mortality. TORCH demonstrated a 17.5% reduction on all-cause mortality with salmeterol-fluticasone propionate combination (SFC) compared with placebo (HR=0.825, 95% CI (0.681, 1.002), p=0.052) in the entire COPD population with disease severity form moderate to very severe. A post hoc analysis of the data restricted to those subjects with an forced expiratory volume in 1 second (FEV1) >=50% predicted with an apparent history of cardiovascular co-morbidities (defined as use at baseline of beta-blockers, angiotensin converting enzyme inhibitors (ACEI)/angiotensin receptor blockers (ARB), HMG CoA reductase inhibitors (i.e. statins) or a prior MI recorded at baseline) demonstrated a 49% reduction in the risk of dying within 96 weeks for the comparison of SFC with placebo. These post hoc data suggest the possibility of an ICS/LABA combination product to be of substantial benefit in COPD subjects with less severe airflow obstruction yet with increased cardiovascular risk.
The mechanism by which SFC appears to be associated with a greater reduction in mortality in these less severe COPD subjects with concomitant cardiovascular comorbidities is speculative at present, but could potentially in part be related to a lessening of the degree of inflammation in the systemic circulation, potential plaque stabilization and/or amelioration of arterial stiffness.
ICS/LABA combinations that are currently available require twice daily administration. A once daily ICS/LABA combination has the potential to improve patient compliance and as a result, overall disease management.
The purpose of this study is to prospectively evaluate the effect of the once daily ICS/LABA combination Fluticasone Furoate (FF)/Vilanterol (VI) on survival in subjects with moderate COPD (>=50 and =<70 % predicted FEV1 ) and a history of, or at increased risk for cardiovascular disease.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- fluticasone furoate/vilanterol, fluticasone furoate, vilanterol, Placebo
- Keywords
- COPD, Cardiovascular disease, Novel Dry Powder Inhaler, Survival
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluticasone furoate/vilanterolDrug
100/25mcg given once daily via novel dry powder inhaler
fluticasone furoateDrug
100mcg given once daily via novel dry powder inhaler
vilanterolDrug
25mcg given once daily via novel dry powder inhaler
PlaceboOther
placebo comparator once daily via novel dry powder inhaler
| Study group | Role | What they receive |
|---|---|---|
| fluticasone furoate/vilanterol | Experimental | Combination of both products in one inhaler Receives: Drug: fluticasone furoate/vilanterol |
| fluticasone furoate | Experimental | comparator of individual component Receives: Drug: fluticasone furoate |
| vilanterol | Experimental | comparator of individual component Receives: Drug: vilanterol |
| placebo | Placebo comparator | once daily via inhaler Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date
Death from any cause: which occurred from the day of starting IP until the Commone End Date (CED). Common End Date (CED) is the study end date that was pre determined where approximately 1000 deaths would have occurred in the Intent-toTreat Efficacy (ITT-E) Population. Only deaths which occurred on or before the CED were used for the primary analysis. Those who had not died by CED, but who were known to be alive on or after the CED, were censored at the CED. Cox Proportional Hazards (PH) Model was adjusted for age, and gender, including all 4 arms. A hazard ratio of less than 1 indicates a lower death rate versus placebo or other arm. ITT-E Population consisted of all participants in the Safety Population (i.e. randomized to IP and who received at least one dose of IP), with the exception of those recruited at sites that were closed.
Measured: From the date of randomization until date of death due to any cause (average of 2 study years)
Secondary outcomes (2)
Decline in Forced Expiratory Volume in 1 Second (FEV1)
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The effect of treatment on decline of post bronchodilator FEV1 recorded during the treatment period was analyzed using a particular form of a mixed effect model - a random coefficients model. FEV1 was fitted as the response variable with treatment group, age, gender, baseline FEV1 and time on treatment as fixed effects. Time on treatment was treated as a continuous variable. This model allowed for an initial increase in FEV1, but then tested the difference in slopes from the first post-baseline measurement which was at 3 months. A negative slope indicates a decline. A positive treatment difference indicates a slower rate of decline vs Placebo or Component. Only participants with at least one on-treatment post-bronchodilator FEV1 measurement were analyzed.
Measured: From start date of IP until IP stop date + 1 (assessed up to 4 years)
Number of Participants With First On-treatment Cardiovascular (CV) Composite Events Occured on or Before Common End Date
On-treatment CV composite event is comprised of the first event that is adjudicated as on-treatment CV death, myocardial infarction, stroke, unstable angina, or transient ischemic attack experienced by a participant. The events that occurred no more than 7 days after the participants last dose of IP are considered as on-treatment adverse events. Common end date is the study end date where approximately 1000 deaths would have occurred in the ITT-E Population. Cox PH Model was used to assess time to first on-treatment CV composite event. Cox PH Model was adjusted for age, gender and indicators of ischemic and vascular disease, including all four treatment arms. A hazard ratio less than 1 indicates a lower risk of a first CV event rate versus placebo or any arm.
Measured: From the start of IP to first on treatment CV event till 7 days after the last dose of IP (average of 2 study years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study start25 Jan 2011
- Primary completion15 Jul 2015
- Study completion15 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16,568 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313676
- Sponsor's protocol ID
- 113782
- Status last verified
- Aug 2018
- First submitted
- 3 Feb 2011
- Last updated
- 6 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Verstraete K, Gyselinck I, Huts H, Das N, Topalovic M, De Vos M, Janssens W. Estimating individual treatment effects on COPD exacerbations by causal machine learning on randomised controlled trials. Thorax. 2023 Oct;78(10):983-989. doi: 10.1136/thorax-2022-219382. Epub 2023 Apr 3.
PubMed 37012070Horne BD, Hegewald MJ, Crim C, Rea S, Bair TL, Blagev DP. The Summit Score Stratifies Mortality and Morbidity in Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2020 Jul 20;15:1741-1750. doi: 10.2147/COPD.S254437. eCollection 2020.
PubMed 32764918Wise RA, Anderson JA, Amarenco P, Cowans NJ, Crim C, Denvir MA, Gomez CR, Jones MP, Morris A, Niewoehner D, Yates JC. Adjudication of cardiovascular events in patients with chronic obstructive pulmonary disease: SUMMIT trial. Clin Trials. 2020 Aug;17(4):430-436. doi: 10.1177/1740774520920897. Epub 2020 May 22.
PubMed 32441114Celli BR, Anderson JA, Brook R, Calverley P, Cowans NJ, Crim C, Dixon I, Kim V, Martinez FJ, Morris A, Newby DE, Yates J, Vestbo J. Serum biomarkers and outcomes in patients with moderate COPD: a substudy of the randomised SUMMIT trial. BMJ Open Respir Res. 2019 May 4;6(1):e000431. doi: 10.1136/bmjresp-2019-000431. eCollection 2019.
PubMed 31258919Fawzy A, Anderson JA, Cowans NJ, Crim C, Wise R, Yates JC, Hansel NN. Association of platelet count with all-cause mortality and risk of cardiovascular and respiratory morbidity in stable COPD. Respir Res. 2019 May 8;20(1):86. doi: 10.1186/s12931-019-1059-1.
PubMed 31068182Vestbo J, Dransfield M, Anderson JA, Brook RD, Calverley PMA, Celli BR, Cowans NJ, Crim C, Martinez F, Newby DE, Yates J, Lange P. Impact of pre-enrolment medication use on clinical outcomes in SUMMIT. ERJ Open Res. 2019 Feb 25;5(1):00203-2018. doi: 10.1183/23120541.00203-2018. eCollection 2019 Feb.
PubMed 30815468Adamson PD, Anderson JA, Brook RD, Calverley PMA, Celli BR, Cowans NJ, Crim C, Dixon IJ, Martinez FJ, Newby DE, Vestbo J, Yates JC, Mills NL. Cardiac Troponin I and Cardiovascular Risk in Patients With Chronic Obstructive Pulmonary Disease. J Am Coll Cardiol. 2018 Sep 4;72(10):1126-1137. doi: 10.1016/j.jacc.2018.06.051.
PubMed 30165984Kunisaki KM, Dransfield MT, Anderson JA, Brook RD, Calverley PMA, Celli BR, Crim C, Hartley BF, Martinez FJ, Newby DE, Pragman AA, Vestbo J, Yates JC, Niewoehner DE; SUMMIT Investigators. Exacerbations of Chronic Obstructive Pulmonary Disease and Cardiac Events. A Post Hoc Cohort Analysis from the SUMMIT Randomized Clinical Trial. Am J Respir Crit Care Med. 2018 Jul 1;198(1):51-57. doi: 10.1164/rccm.201711-2239OC.
PubMed 29442524Celli B, Anderson JA, Brook R, Calverley P, Crim C, Holmes AP, Martinez FJ, Newby DE, Yates J, Vestbo J; SUMMIT Investigators. Long-Acting beta-Agonist/Inhaled Corticosteroid in Patients with Chronic Obstructive Pulmonary Disease with Cardiovascular Disease or Risk: A Factorial Analysis of the SUMMIT Clinical Trial. Am J Respir Crit Care Med. 2018 Jun 15;197(12):1641-1644. doi: 10.1164/rccm.201710-2052LE. No abstract available.
PubMed 29412688Dransfield MT, McAllister DA, Anderson JA, Brook RD, Calverley PMA, Celli BR, Crim C, Gallot N, Martinez FJ, Scanlon PD, Yates J, Vestbo J, Newby DE; SUMMIT Investigators. beta-Blocker Therapy and Clinical Outcomes in Patients with Moderate Chronic Obstructive Pulmonary Disease and Heightened Cardiovascular Risk. An Observational Substudy of SUMMIT. Ann Am Thorac Soc. 2018 May;15(5):608-614. doi: 10.1513/AnnalsATS.201708-626OC.
PubMed 29406772Bhatt SP, Anderson JA, Brook RD, Calverley PMA, Celli BR, Cowans NJ, Crim C, Martinez FJ, Newby DE, Vestbo J, Yates JC, Dransfield MT. Cigarette smoking and response to inhaled corticosteroids in COPD. Eur Respir J. 2018 Jan 18;51(1):1701393. doi: 10.1183/13993003.01393-2017. Print 2018 Jan. No abstract available.
PubMed 29348179Crim C, Calverley PMA, Anderson JA, Holmes AP, Kilbride S, Martinez FJ, Brook RD, Newby DE, Yates JC, Celli BR, Vestbo J; SUMMIT investigators. Pneumonia risk with inhaled fluticasone furoate and vilanterol in COPD patients with moderate airflow limitation: The SUMMIT trial. Respir Med. 2017 Oct;131:27-34. doi: 10.1016/j.rmed.2017.07.060. Epub 2017 Aug 1.
PubMed 28947039Calverley PMA, Anderson JA, Brook RD, Crim C, Gallot N, Kilbride S, Martinez FJ, Yates J, Newby DE, Vestbo J, Wise R, Celli BR; SUMMIT (Study to Understand Mortality and Morbidity) Investigators. Fluticasone Furoate, Vilanterol, and Lung Function Decline in Patients with Moderate Chronic Obstructive Pulmonary Disease and Heightened Cardiovascular Risk. Am J Respir Crit Care Med. 2018 Jan 1;197(1):47-55. doi: 10.1164/rccm.201610-2086OC.
PubMed 28737971Brook RD, Anderson JA, Calverley PM, Celli BR, Crim C, Denvir MA, Magder S, Martinez FJ, Rajagopalan S, Vestbo J, Yates J, Newby DE; SUMMIT Investigators. Cardiovascular outcomes with an inhaled beta2-agonist/corticosteroid in patients with COPD at high cardiovascular risk. Heart. 2017 Oct;103(19):1536-1542. doi: 10.1136/heartjnl-2016-310897. Epub 2017 Apr 17.
PubMed 28416587Martinez FJ, Vestbo J, Anderson JA, Brook RD, Celli BR, Cowans NJ, Crim C, Dransfield M, Kilbride S, Yates J, Newby DE, Niewoehner D, Calverley PM; SUMMIT Investigators. Effect of Fluticasone Furoate and Vilanterol on Exacerbations of Chronic Obstructive Pulmonary Disease in Patients with Moderate Airflow Obstruction. Am J Respir Crit Care Med. 2017 Apr 1;195(7):881-888. doi: 10.1164/rccm.201607-1421OC.
PubMed 27767328
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Outcomes Study to Compare the Effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg With Placebo on Survival in Subjects With Moderate Chronic Obstructive Pulmonary Disease (COPD) and a History of or at Increased Risk for Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT01313676
- Acronym / sponsor ID
- 113782
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD, Cardiovascular disease, Novel Dry Powder Inhaler, Survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16,568 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2011 (actual)
- Primary completion
- 15 Jul 2015 (actual)
- Study completion
- 15 Jul 2015 (actual)
- First posted
- 14 Mar 2011 (estimated)
- Results
- Posted 9 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if fluticasone furoate/vilanterol improves survival in patients with chronic obstructive pulmonary disease with a history of or increased risk of heart disease.
Detailed description
Despite a potential link between the pathogenetic mechanisms involved in Chronic Obstructive Pulmonary Disease (COPD) and atherosclerotic cardiovascular disease, there are no currently approved therapies for patients with COPD that have clearly shown an additional beneficial effect in patients with cardiovascular comorbidities. The TOwards a Revolution in COPD Health (TORCH) study assessed the impact of the inhaled corticosteroid (ICS) fluticasone propionate (FP) in combination with the long-acting beta agonist (LABA), salmeterol (SAL), in reducing all-cause mortality. TORCH demonstrated a 17.5% reduction on all-cause mortality with salmeterol-fluticasone propionate combination (SFC) compared with placebo (HR=0.825, 95% CI (0.681, 1.002), p=0.052) in the entire COPD population with disease severity form moderate to very severe. A post hoc analysis of the data restricted to those subjects with an forced expiratory volume in 1 second (FEV1) >=50% predicted with an apparent history of cardiovascular co-morbidities (defined as use at baseline of beta-blockers, angiotensin converting enzyme inhibitors (ACEI)/angiotensin receptor blockers (ARB), HMG CoA reductase inhibitors (i.e. statins) or a prior MI recorded at baseline) demonstrated a 49% reduction in the risk of dying within 96 weeks for the comparison of SFC with placebo. These post hoc data suggest the possibility of an ICS/LABA combination product to be of substantial benefit in COPD subjects with less severe airflow obstruction yet with increased cardiovascular risk.
The mechanism by which SFC appears to be associated with a greater reduction in mortality in these less severe COPD subjects with concomitant cardiovascular comorbidities is speculative at present, but could potentially in part be related to a lessening of the degree of inflammation in the systemic circulation, potential plaque stabilization and/or amelioration of arterial stiffness.
ICS/LABA combinations that are currently available require twice daily administration. A once daily ICS/LABA combination has the potential to improve patient compliance and as a result, overall disease management.
The purpose of this study is to prospectively evaluate the effect of the once daily ICS/LABA combination Fluticasone Furoate (FF)/Vilanterol (VI) on survival in subjects with moderate COPD (>=50 and =<70 % predicted FEV1 ) and a history of, or at increased risk for cardiovascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| fluticasone furoate/vilanterol | Experimental | Drug: fluticasone furoate/vilanterolCombination of both products in one inhaler |
| fluticasone furoate | Experimental | Drug: fluticasone furoatecomparator of individual component |
| vilanterol | Experimental | Drug: vilanterolcomparator of individual component |
| placebo | Placebo comparator | Other: Placeboonce daily via inhaler |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Type of subject: outpatient.
- Informed consent: Subjects must give their signed and dated written informed consent to participate.
- Gender: Male or female. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception.
- Age: >=40 and <=80 years of age at Screening (Visit 1).
- Tobacco use: Subjects with a current or prior history of >=10 pack-years of cigarette smoking at screening (Visit 1). Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
Key exclusion criteria (16 listed)
- Pregnancy: Women who are pregnant or lactating.
- Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they also have a current diagnosis of COPD).
- alpha 1-antitrypsin deficiency: Subjects with known alpha-1 antitrypsin deficiency as the underlying cause of COPD.
- Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
- Lung resection or transplantation: Subjects with lung volume reduction surgery within the 12 months prior to Screening or having had a lung transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluticasone furoate/vilanterol100/25mcg given once daily via novel dry powder inhaler | Drug | fluticasone furoate/vilanterol |
| fluticasone furoate100mcg given once daily via novel dry powder inhaler | Drug | fluticasone furoate |
| vilanterol25mcg given once daily via novel dry powder inhaler | Drug | vilanterol |
| Placeboplacebo comparator once daily via novel dry powder inhaler | Other | placebo |
Primary outcome
Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date
Time frame: From the date of randomization until date of death due to any cause (average of 2 study years)
Death from any cause: which occurred from the day of starting IP until the Commone End Date (CED). Common End Date (CED) is the study end date that was pre determined where approximately 1000 deaths would have occurred in the Intent-toTreat Efficacy (ITT-E) Population. Only deaths which occurred on or before the CED were used for the primary analysis. Those who had not died by CED, but who were known to be alive on or after the CED, were censored at the CED. Cox Proportional Hazards (PH) Model was adjusted for age, and gender, including all 4 arms. A hazard ratio of less than 1 indicates a lower death rate versus placebo or other arm. ITT-E Population consisted of all participants in the Safety Population (i.e. randomized to IP and who received at least one dose of IP), with the exception of those recruited at sites that were closed.
2 secondary outcomes
Decline in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: From start date of IP until IP stop date + 1 (assessed up to 4 years)
Number of Participants With First On-treatment Cardiovascular (CV) Composite Events Occured on or Before Common End Date
Time frame: From the start of IP to first on treatment CV event till 7 days after the last dose of IP (average of 2 study years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37012070Verstraete K, Gyselinck I, Huts H, Das N, Topalovic M, De Vos M, Janssens W. Estimating individual treatment effects on COPD exacerbations by causal machine learning on randomised controlled trials. Thorax. 2023 Oct;78(10):983-989. doi: 10.1136/thorax-2022-219382. Epub 2023 Apr 3.
- Derived from this study: PubMed 32764918Horne BD, Hegewald MJ, Crim C, Rea S, Bair TL, Blagev DP. The Summit Score Stratifies Mortality and Morbidity in Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2020 Jul 20;15:1741-1750. doi: 10.2147/COPD.S254437. eCollection 2020.
- Derived from this study: PubMed 32441114Wise RA, Anderson JA, Amarenco P, Cowans NJ, Crim C, Denvir MA, Gomez CR, Jones MP, Morris A, Niewoehner D, Yates JC. Adjudication of cardiovascular events in patients with chronic obstructive pulmonary disease: SUMMIT trial. Clin Trials. 2020 Aug;17(4):430-436. doi: 10.1177/1740774520920897. Epub 2020 May 22.
- Derived from this study: PubMed 31258919Celli BR, Anderson JA, Brook R, Calverley P, Cowans NJ, Crim C, Dixon I, Kim V, Martinez FJ, Morris A, Newby DE, Yates J, Vestbo J. Serum biomarkers and outcomes in patients with moderate COPD: a substudy of the randomised SUMMIT trial. BMJ Open Respir Res. 2019 May 4;6(1):e000431. doi: 10.1136/bmjresp-2019-000431. eCollection 2019.
- Derived from this study: PubMed 31068182Fawzy A, Anderson JA, Cowans NJ, Crim C, Wise R, Yates JC, Hansel NN. Association of platelet count with all-cause mortality and risk of cardiovascular and respiratory morbidity in stable COPD. Respir Res. 2019 May 8;20(1):86. doi: 10.1186/s12931-019-1059-1.
- Derived from this study: PubMed 30815468Vestbo J, Dransfield M, Anderson JA, Brook RD, Calverley PMA, Celli BR, Cowans NJ, Crim C, Martinez F, Newby DE, Yates J, Lange P. Impact of pre-enrolment medication use on clinical outcomes in SUMMIT. ERJ Open Res. 2019 Feb 25;5(1):00203-2018. doi: 10.1183/23120541.00203-2018. eCollection 2019 Feb.
- Derived from this study: PubMed 30165984Adamson PD, Anderson JA, Brook RD, Calverley PMA, Celli BR, Cowans NJ, Crim C, Dixon IJ, Martinez FJ, Newby DE, Vestbo J, Yates JC, Mills NL. Cardiac Troponin I and Cardiovascular Risk in Patients With Chronic Obstructive Pulmonary Disease. J Am Coll Cardiol. 2018 Sep 4;72(10):1126-1137. doi: 10.1016/j.jacc.2018.06.051.
- Derived from this study: PubMed 29442524Kunisaki KM, Dransfield MT, Anderson JA, Brook RD, Calverley PMA, Celli BR, Crim C, Hartley BF, Martinez FJ, Newby DE, Pragman AA, Vestbo J, Yates JC, Niewoehner DE; SUMMIT Investigators. Exacerbations of Chronic Obstructive Pulmonary Disease and Cardiac Events. A Post Hoc Cohort Analysis from the SUMMIT Randomized Clinical Trial. Am J Respir Crit Care Med. 2018 Jul 1;198(1):51-57. doi: 10.1164/rccm.201711-2239OC.
- Derived from this study: PubMed 29412688Celli B, Anderson JA, Brook R, Calverley P, Crim C, Holmes AP, Martinez FJ, Newby DE, Yates J, Vestbo J; SUMMIT Investigators. Long-Acting beta-Agonist/Inhaled Corticosteroid in Patients with Chronic Obstructive Pulmonary Disease with Cardiovascular Disease or Risk: A Factorial Analysis of the SUMMIT Clinical Trial. Am J Respir Crit Care Med. 2018 Jun 15;197(12):1641-1644. doi: 10.1164/rccm.201710-2052LE. No abstract available.
- Derived from this study: PubMed 29406772Dransfield MT, McAllister DA, Anderson JA, Brook RD, Calverley PMA, Celli BR, Crim C, Gallot N, Martinez FJ, Scanlon PD, Yates J, Vestbo J, Newby DE; SUMMIT Investigators. beta-Blocker Therapy and Clinical Outcomes in Patients with Moderate Chronic Obstructive Pulmonary Disease and Heightened Cardiovascular Risk. An Observational Substudy of SUMMIT. Ann Am Thorac Soc. 2018 May;15(5):608-614. doi: 10.1513/AnnalsATS.201708-626OC.
- Derived from this study: PubMed 29348179Bhatt SP, Anderson JA, Brook RD, Calverley PMA, Celli BR, Cowans NJ, Crim C, Martinez FJ, Newby DE, Vestbo J, Yates JC, Dransfield MT. Cigarette smoking and response to inhaled corticosteroids in COPD. Eur Respir J. 2018 Jan 18;51(1):1701393. doi: 10.1183/13993003.01393-2017. Print 2018 Jan. No abstract available.
- Derived from this study: PubMed 28947039Crim C, Calverley PMA, Anderson JA, Holmes AP, Kilbride S, Martinez FJ, Brook RD, Newby DE, Yates JC, Celli BR, Vestbo J; SUMMIT investigators. Pneumonia risk with inhaled fluticasone furoate and vilanterol in COPD patients with moderate airflow limitation: The SUMMIT trial. Respir Med. 2017 Oct;131:27-34. doi: 10.1016/j.rmed.2017.07.060. Epub 2017 Aug 1.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1,611 sites in 44 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fluticasone furoate/vilanterol, fluticasone furoate and vilanterol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1,611 sites in 44 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1,611 sites in United States, Russia, Poland, Germany, Argentina and 39 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date (time frame: From the date of randomization until date of death due to any cause (average of 2 study years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01313676, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.