Pulmonary Disease, Chronic ObstructivePhase 3NCT02164513

A Study Comparing the Efficacy, Safety and Tolerability of Fixed Dose Combination (FDC) of FF/UMEC/VI With the FDC of FF/VI and UMEC/VI; Administered Once-daily Via a Dry Powder Inhaler (DPI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing fluticasone furoate (FF), vilanterol (VI) and umeclidinium bromide (UMEC) in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 998 sites in 37 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: fluticasone furoate (FF), vilanterol (VI) and umeclidinium bromide (UMEC)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10,355 participants
Where: 998 sitesin 37 countries
Study dates: 30 Jun 2014to 17 Jul 2017
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Informed Consent: A signed and dated written informed consent prior to study participation
Type of subject: Outpatient
Age: Subjects 40 years of age or older at Visit 1
Gender: Male or female subjects. A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, > 45 years, in the absence of hormone replacement therapy OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to safety follow-up contact): Abstinence; Oral Contraceptive, either combined or progestogen alone; Injectable progestogen; Implants of levonorgestrel; Estrogenic vaginal ring; Percutaneous contraceptive patches; Intrauterine device (IUD) or intrauterine system (IUS); Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, "documented" refers to the outcome of the investigator's/designee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records. Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
COPD Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
Smoking History: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at screening (visit 1) [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Note: Pipe and/or cigar use cannot be used to calculate pack-year history

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Severity of COPD symptoms: A score of >=10 on the COPD Assessment Test (CAT) at screening
Severity of COPD Disease: A post-albuterol/salbutamol FEV1/ Forced Vital Capacity (FVC) ratio of <0.70 at Screening
Existing COPD maintenance treatment: Subject must be receiving daily maintenance treatment for their COPD for at least 3 months prior to Screening. Note: Subjects receiving only Pro re nata (PRN) COPD medications are not eligible
History of Exacerbations: Subjects must demonstrate: a post-bronchodilator FEV1 <50% predicted normal and a documented history of >= 1 moderate or severe COPD exacerbation in the previous 12 months OR a post-bronchodilator 50% <=FEV1 < 80% predicted normal and a documented history of >= 2 moderate exacerbations or a documented history of >=1 severe COPD exacerbation (hospitalized) in the previous 12 months. Note: Percent predicted will be calculated using the European Respiratory Society Global Lung Function Initiative reference equations. Note: A documented history of a COPD exacerbation (e.g., medical record verification) is a medical record of worsening COPD symptoms that required systemic/oral corticosteroids and/or antibiotics (for a moderate exacerbation) or hospitalization (for a severe exacerbation). Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnea, sputum volume, or sputum purulence (color). Subject verbal reports are not acceptable
Liver function tests: alanine aminotransferase (ALT) <2x upper limit of normal (ULN); alkaline phosphatase <=1.5xULN; bilirubin <=1.5xULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category

Who cannot join

Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study
Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD)
Alpha1-antitrypsin deficiency: Subjects with Alpha1-antitrypsin deficiency as the underlying cause of COPD
Other respiratory disorders: Subjects with active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening
Risk Factors for Pneumonia: immune suppression (e.g. human immunodeficiency virus [HIV], Lupus) or other risk factors for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's Disease, Myasthenia Gravis). Patients at potentially high risk (e.g. very low BMI, severely malnourished, or very low FEV1) will only be included at the discretion of the Investigator

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Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening and at least 30 days following the last dose of oral/systemic corticosteroids (if applicable). In addition, any subject that experiences pneumonia and/or moderate or severe COPD exacerbation during the run-in period will be excluded
Other Respiratory tract infections that have not resolved at least 7 days prior to screening
Abnormal Chest x-ray(CXR): Chest x-ray (posteroanterior and lateral) reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD, or another condition that would hinder the ability to detect an infiltrate on CXR (e.g. significant cardiomegaly, pleural effusion or scarring). All subjects will have a chest x-ray at Screening Visit 1 (or historical radiograph or computerised tomography (CT) scan obtained within 3 months prior to screening) that will be over-read by a central vendor. Note: Subjects who have experienced pneumonia and/or moderate or severe COPD exacerbation within 3 months of screening must provide a post pneumonia/exacerbation chest x-ray to be over-read by the central vendor or have a chest x-ray conducted at screening. For sites in Germany: If a chest x-ray (or CT scan) within 3 months prior to Screening (Visit 1) is not available, approval to conduct a diagnostic chest x-ray will need to be obtained from the Federal Office for Radiation Protection (Bundesamt für Strahlenschutz [BfS])
Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study
Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Note: Chronic stable hepatitis B and C are acceptable if the subject otherwise meets entry criteria
Unstable or life threatening cardiac disease: subjects with any of the following at Screening (Visit 1) would be excluded: Myocardial infarction or unstable angina in the last 6 months; Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months; New York Heart Association (NYHA) Class IV Heart failure
Abnormal and clinically significant 12-Lead Electrocardiogram (ECG) finding: Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. The Principal Investigator will determine the clinical significance of each abnormal ECG finding in relation to the subject's medical history and exclude subjects who would be at undue risk by participating in the trial. An abnormal and clinically significant finding that would preclude a subject from entering the trial is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following: atrial fibrillation (AF) with rapid ventricular rate >120 beats per minute); sustained or nonsustained ventricular tachycardia (VT); Second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator had been inserted); QT interval corrected for heart rate (QTcF) >=500 milliseconds (msec) in patients with QRS <120 msec and QTcF >=530 msec in patients with QRS >=120 msec
Contraindications: A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the Investigator contraindicates study participation
Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the subject has been considered cured by treatment
Oxygen therapy: Use of long-term oxygen therapy (LTOT) described as resting oxygen therapy >3 Liter/minute (L/min) (Oxygen use =<3L/min flow is not exclusionary)
Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol for the 4-hour period required prior to spirometry testing at each study visit
Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening or subjects who plan to enter the acute phase of a Pulmonary Rehabilitation Program during the study. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program are not excluded
Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years
Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits
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
Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or study site, or immediate family members of the aforementioned that is involved with this study
Inability to read: In the opinion of the Investigator, any subject who is unable to read and/or would not be able to complete study related materials
Medication prior to screening: Use of the following medications within the following time intervals prior to Screening (Visit 1) or during the study: Long term antibiotic therapy Subjects receiving antibiotics for long term therapy are not eligible for the study (Antibiotics are allowed for the short term treatment of an exacerbation or for short term treatment of other acute infections during the study); Systemic, Oral, parenteral corticosteroids 30 days (Except during the study oral/systemic corticosteroids may be used to treat COPD exacerbations/pneumonia) Intra-articular injections are allowed; Any other investigational drug (30 days or 5 half lives whichever is longer)

Trial locations and contacts

998 sites in 37 countries.

Country

City, postcode or hospital

998 sites in 37 countries

United States269 sites

GSK Investigational Site
Abingdon, Virginia, 24210
GSK Investigational Site
Adairsville, Georgia, 30103
GSK Investigational Site
Albany, New York, 12208
GSK Investigational Site
Albuquerque, New Mexico, 87108
GSK Investigational Site
Anderson, South Carolina, 29621
GSK Investigational Site
Ann Arbor, Michigan, 48106
GSK Investigational Site
Arcadia, California, 91007
GSK Investigational Site
Asheville, North Carolina, 28801
GSK Investigational Site
Athens, Alabama, 35611
GSK Investigational Site
Athens, Georgia, 30606
GSK Investigational Site
Austell, Georgia, 30106
GSK Investigational Site
Bakersfield, California, 93301
GSK Investigational Site
Bangor, Maine, 04401
GSK Investigational Site
Bay Pines, Florida, 33744
GSK Investigational Site
Bellingham, Washington, 98225
GSK Investigational Site
Birmingham, Alabama, 35215
GSK Investigational Site
Birmingham, Alabama, 35216
GSK Investigational Site
Birmingham, Alabama, 35294
GSK Investigational Site
Boulder, Colorado, 80301
GSK Investigational Site
Boynton Beach, Florida, 33436
GSK Investigational Site
Brandon, Florida, 33511
GSK Investigational Site
Bronxville, New York, 10708
GSK Investigational Site
Butte, Montana, 59701
GSK Investigational Site
Calabash, North Carolina, 28467
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Celebration, Florida, 34747
GSK Investigational Site
Chandler, Arizona, 85284
GSK Investigational Site
Charleston, South Carolina, 29406-7108
GSK Investigational Site
Charlotte, North Carolina, 28207
GSK Investigational Site
Charlotte, North Carolina, 28262
GSK Investigational Site
Charlotte, North Carolina, 28277
GSK Investigational Site
Chattanooga, Tennessee, 37404
GSK Investigational Site
Chesterfield, Missouri, 63017
GSK Investigational Site
Chicago, Illinois, 60611
GSK Investigational Site
Chula Vista, California, 91910
GSK Investigational Site
Cincinnati, Ohio, 45220
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Cincinnati, Ohio, 45245
GSK Investigational Site
Clearwater, Florida, 33759
GSK Investigational Site
Clearwater, Florida, 33765-2616
GSK Investigational Site
Coeur d'Alene, Idaho, 83814
GSK Investigational Site
Colorado Springs, Colorado, 80907
GSK Investigational Site
Columbia, Maryland, 21044
GSK Investigational Site
Columbia, South Carolina, 29204
GSK Investigational Site
Columbia, South Carolina, 29209
GSK Investigational Site
Columbus, Georgia, 31904
GSK Investigational Site
Columbus, Ohio, 43213
GSK Investigational Site
Conyers, Georgia, 30094
GSK Investigational Site
Corsicana, Texas, 75110
GSK Investigational Site
Corvallis, Oregon, 97330
GSK Investigational Site
Council Bluffs, Iowa, 51503
GSK Investigational Site
Crowley, Louisiana, 70526
GSK Investigational Site
Danbury, Connecticut, 06810
GSK Investigational Site
Dayton, Ohio, 45459
GSK Investigational Site
Daytona Beach, Florida, 32117
GSK Investigational Site
Decatur, Georgia, 30033
GSK Investigational Site
DeLand, Florida, 32720
GSK Investigational Site
Downingtown, Pennsylvania, 19335
GSK Investigational Site
Doylestown, Pennsylvania, 18901
GSK Investigational Site
Duluth, Georgia, 30096
GSK Investigational Site
Duluth, Minnesota, 55805
GSK Investigational Site
Durham, North Carolina, 27710
GSK Investigational Site
Easley, South Carolina, 29640
GSK Investigational Site
East Providence, Rhode Island, 02914
GSK Investigational Site
Edgewater, Florida, 32132
GSK Investigational Site
Edina, Minnesota, 55435
GSK Investigational Site
Edinburg, Texas, 78539
GSK Investigational Site
Elizabeth City, North Carolina, 27909
GSK Investigational Site
Elk Grove Village, Illinois, 60007
GSK Investigational Site
Encinitas, California, 92024
GSK Investigational Site
Erie, Pennsylvania, 16508
GSK Investigational Site
Escondido, California, 92025
GSK Investigational Site
Evansville, Indiana, 47714
GSK Investigational Site
Everett, Washington, 98208
GSK Investigational Site
Fall River, Massachusetts, 02720
GSK Investigational Site
Flagstaff, Arizona, 86001
GSK Investigational Site
Florence, Alabama, 35630
GSK Investigational Site
Fort Collins, Colorado, 80538
GSK Investigational Site
Fort Lauderdale, Florida, 33306
GSK Investigational Site
Fort Mill, South Carolina, 29707
GSK Investigational Site
Fort Mitchell, Kentucky, 41017
GSK Investigational Site
Fort Myers, Florida, 33908
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Franklin, Indiana, 46131
GSK Investigational Site
Fremont, Nebraska, 68025
GSK Investigational Site
Fridley, Minnesota, 55432
GSK Investigational Site
Gaffney, South Carolina, 29340
GSK Investigational Site
Gaffney, South Carolina, 29341
GSK Investigational Site
Gainesville, Florida, 32608
GSK Investigational Site
Gainesville, Georgia, 30501
GSK Investigational Site
Gastonia, North Carolina, 28054
GSK Investigational Site
Gillespie, Illinois, 62033
GSK Investigational Site
Glendale, Arizona, 85306
GSK Investigational Site
Golden, Colorado, 80401
GSK Investigational Site
Gonzales, Texas, 78629
GSK Investigational Site
Grand Island, Nebraska, 68803
GSK Investigational Site
Greenfield, Indiana, 46140
GSK Investigational Site
Greensboro, North Carolina, 27403
GSK Investigational Site
Greenville, South Carolina, 29615
GSK Investigational Site
Hampton, Virginia, 23666
GSK Investigational Site
Hartford, Connecticut, 06105
GSK Investigational Site
Hendersonville, North Carolina, 28739
GSK Investigational Site
Hendersonville, Tennessee, 37075
GSK Investigational Site
Hines, Illinois, 60124
GSK Investigational Site
Hollywood, Florida, 33024
GSK Investigational Site
Hollywood, Maryland, 20636
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Houston, Texas, 77034
GSK Investigational Site
Houston, Texas, 77043
GSK Investigational Site
Huntersville, North Carolina, 28078
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Iowa City, Iowa, 52242
GSK Investigational Site
Jackson, Mississippi, 39202
GSK Investigational Site
Jacksonville, Florida, 32204
GSK Investigational Site
Jacksonville, Florida, 32205
GSK Investigational Site
Jacksonville, Florida, 32207
GSK Investigational Site
Jacksonville, Florida, 32209
GSK Investigational Site
Jacksonville, Florida, 32216
GSK Investigational Site
Jasper, Alabama, 35501
GSK Investigational Site
Johnson City, Tennessee, 37601
GSK Investigational Site
Johnstown, Pennsylvania, 15905
GSK Investigational Site
Kansas City, Missouri, 64128
GSK Investigational Site
Katy, Texas, 77450
GSK Investigational Site
Kerrville, Texas, 78028
GSK Investigational Site
Kingwood, Texas, 77339
GSK Investigational Site
Lafayette, Louisiana, 70508
GSK Investigational Site
Las Vegas, Nevada, 89106
GSK Investigational Site
Leesburg, Florida, 34748
GSK Investigational Site
Lewisville, Texas, 75067
GSK Investigational Site
Lexington, North Carolina, 27292
GSK Investigational Site
Lincoln, Nebraska, 68506
GSK Investigational Site
Long Beach, California, 90808
GSK Investigational Site
Long Beach, California, 90822
GSK Investigational Site
Longview, Texas, 75605
GSK Investigational Site
Louisville, Kentucky, 40218
GSK Investigational Site
Loxahatchee Groves, Florida, 33470
GSK Investigational Site
Lynchburg, Virginia, 24501
GSK Investigational Site
Maitland, Florida, 32751
GSK Investigational Site
Marietta, Georgia, 30060
GSK Investigational Site
Marion, Ohio, 43302
GSK Investigational Site
Marlton, New Jersey, 08053
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Miami, Florida, 33015
GSK Investigational Site
Miami, Florida, 33137
GSK Investigational Site
Middleburg Heights, Ohio, 44130
GSK Investigational Site
Minneapolis, Minnesota, 55402
GSK Investigational Site
Minneapolis, Minnesota, 55407
GSK Investigational Site
Mission Hills, California, 91345
GSK Investigational Site
Missoula, Montana, 59808
GSK Investigational Site
Mobile, Alabama, 36608
GSK Investigational Site
Modesto, California, 95350
GSK Investigational Site
Moorestown, New Jersey, 08057
GSK Investigational Site
Mooresville, North Carolina, 28117
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464
GSK Investigational Site
Muncie, Indiana, 47303
GSK Investigational Site
Muscle Shoals, Alabama, 35662
GSK Investigational Site
Neptune City, New Jersey, 07753
GSK Investigational Site
New Haven, Connecticut, 06520
GSK Investigational Site
New Orleans, Louisiana, 70112
GSK Investigational Site
New Orleans, Louisiana, 70115
GSK Investigational Site
New Orleans, Louisiana, 70119
GSK Investigational Site
New Port Richey, Florida, 34652
GSK Investigational Site
New York, New York, 10009
GSK Investigational Site
New York, New York, 10016
GSK Investigational Site
New York, New York, 10029
GSK Investigational Site
Newport Beach, California, 92663
GSK Investigational Site
North Dartmouth, Massachusetts, 02747
GSK Investigational Site
O'Fallon, Illinois, 62269
GSK Investigational Site
Oak Park, Illinois, 60302
GSK Investigational Site
Olathe, Kansas, 66061
GSK Investigational Site
Omaha, Nebraska, 68131
GSK Investigational Site
Omaha, Nebraska, 68134
GSK Investigational Site
Orlando, Florida, 32825
GSK Investigational Site
Oviedo, Florida, 32765
GSK Investigational Site
Paducah, Kentucky, 42003
GSK Investigational Site
Palo Alto, California, 94304
GSK Investigational Site
Pembroke Pines, Florida, 33027
GSK Investigational Site
Pensacola, Florida, 32503
GSK Investigational Site
Peoria, Arizona, 85381
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
GSK Investigational Site
Philadelphia, Pennsylvania, 19140
GSK Investigational Site
Philadelphia, Pennsylvania, 19142
GSK Investigational Site
Phoenix, Arizona, 85018
GSK Investigational Site
Phoenix, Arizona, 85032
GSK Investigational Site
Phoenixville, Pennsylvania, 19460
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Pittsburgh, Pennsylvania, 15243
GSK Investigational Site
Pittsfield, Massachusetts, 01201
GSK Investigational Site
Plano, Texas, 75093
GSK Investigational Site
Ponte Vedra Beach, Florida, 32081
GSK Investigational Site
Port Charlotte, Florida, 33952
GSK Investigational Site
Port Charlotte, Florida, 33980
GSK Investigational Site
Port Orange, Florida, 32127
GSK Investigational Site
Portland, Oregon, 97220
GSK Investigational Site
Portland, Oregon, 97225
GSK Investigational Site
Portland, Oregon, 97239
GSK Investigational Site
Quincy, Illinois, 62301
GSK Investigational Site
Rapid City, South Dakota, 57702
GSK Investigational Site
Reno, Nevada, 89503
GSK Investigational Site
Renton, Washington, 98055
GSK Investigational Site
Renton, Washington, 98057
GSK Investigational Site
Reseda, California, 91335
GSK Investigational Site
Richmond, Virginia, 23225
GSK Investigational Site
Richmond, Virginia, 23229
GSK Investigational Site
Richmond, Virginia, 23249
GSK Investigational Site
Rincon, Georgia, 31326
GSK Investigational Site
Riverside, California, 92506
GSK Investigational Site
Rochester, Minnesota, 55905
GSK Investigational Site
Rock Hill, South Carolina, 29732
GSK Investigational Site
Rolling Hills Estates, California, 90274
GSK Investigational Site
Sacramento, California, 95821
GSK Investigational Site
Saint Charles, Missouri, 63301
GSK Investigational Site
Saint Paul, Minnesota, 55130
GSK Investigational Site
San Antonio, Texas, 78215
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Diego, California, 92117
GSK Investigational Site
Santa Ana, California, 92705
GSK Investigational Site
Santa Monica, California, 90404
GSK Investigational Site
Sarasota, Florida, 34239
GSK Investigational Site
Sealy, Texas, 77474
GSK Investigational Site
Seattle, Washington, 98122
GSK Investigational Site
Seneca, South Carolina, 29678
GSK Investigational Site
Sheffield, Alabama, 35660
GSK Investigational Site
Shelby, North Carolina, 28150
GSK Investigational Site
Shelby, North Carolina, 28152
GSK Investigational Site
Shreveport, Louisiana, 71103
GSK Investigational Site
Sioux Falls, South Dakota, 57108
GSK Investigational Site
Southfield, Michigan, 48034
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Spokane Valley, Washington, 99216
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
St. Petersburg, Florida, 33704
GSK Investigational Site
Stamford, Connecticut, 06902
GSK Investigational Site
Sugar Land, Texas, 77479
GSK Investigational Site
Sunset, Louisiana, 70584
GSK Investigational Site
Syracuse, New York, 13210
GSK Investigational Site
Tabor City, North Carolina, 28463
GSK Investigational Site
Tacoma, Washington, 98405
GSK Investigational Site
Tampa, Florida, 33603
GSK Investigational Site
The Bronx, New York, 10457
GSK Investigational Site
The Bronx, New York, 10461
GSK Investigational Site
Tipton, Pennsylvania, 16684
GSK Investigational Site
Toledo, Ohio, 43606
GSK Investigational Site
Toledo, Ohio, 43617
GSK Investigational Site
Tomball, Texas, 77375
GSK Investigational Site
Topeka, Kansas, 66606
GSK Investigational Site
Torrance, California, 90505
GSK Investigational Site
Troy, Michigan, 48085
GSK Investigational Site
Tucson, Arizona, 85723
GSK Investigational Site
Tucson, Arizona, 85724-5023
GSK Investigational Site
Tucson, Arizona, 85745
GSK Investigational Site
Tustin, California, 92780
GSK Investigational Site
Union, South Carolina, 29379
GSK Investigational Site
Upland, California, 91786
GSK Investigational Site
Virginia Beach, Virginia, 23454
GSK Investigational Site
Vista, California, 92083
GSK Investigational Site
Waterbury, Connecticut, 06708
GSK Investigational Site
West Haven, Connecticut, 06516
GSK Investigational Site
Whiteville, North Carolina, 28472
GSK Investigational Site
Wichita, Kansas, 67218
GSK Investigational Site
Wilmington, North Carolina, 28401
GSK Investigational Site
Winfield, Illinois, 60190
GSK Investigational Site
Winston-Salem, North Carolina, 27103
GSK Investigational Site
Woodbury, Minnesota, 55125
GSK Investigational Site
Woodstock, Georgia, 30189
GSK Investigational Site
Wooster, Ohio, 44691
GSK Investigational Site
Worcester, Massachusetts, 01608
GSK Investigational Site
Wyomissing, Pennsylvania, 19610

Other trials in United States

Germany115 sites

GSK Investigational Site
Aschaffenburg, Bavaria, 63739
GSK Investigational Site
Auerbach, Saxony, 08209
GSK Investigational Site
Augsburg, Bavaria, 86150
GSK Investigational Site
Bad Lippspringe, North Rhine-Westphalia, 33175
GSK Investigational Site
Bad Woerrishofen, Bavaria, 86825
GSK Investigational Site
Bamberg, Bavaria, 96049
GSK Investigational Site
Bensheim, Hesse, 64625
GSK Investigational Site
Bergisch Gladbach, North Rhine-Westphalia, 51429
GSK Investigational Site
Berlin, 10119
GSK Investigational Site
Berlin, 10247
GSK Investigational Site
Berlin, 10367
GSK Investigational Site
Berlin, 10625
GSK Investigational Site
Berlin, 10717
GSK Investigational Site
Berlin, 10961
GSK Investigational Site
Berlin, 10969
GSK Investigational Site
Berlin, 12043
GSK Investigational Site
Berlin, 12157
GSK Investigational Site
Berlin, 12159
GSK Investigational Site
Berlin, 12203
GSK Investigational Site
Berlin, 12627
GSK Investigational Site
Berlin, 13057
GSK Investigational Site
Berlin, 13086
GSK Investigational Site
Berlin, 13156
GSK Investigational Site
Berlin, 13187
GSK Investigational Site
Berlin, 13353
GSK Investigational Site
Berlin, 13507
GSK Investigational Site
Berlin, 13581
GSK Investigational Site
Berlin, 14059
GSK Investigational Site
Bernkastel-Kues, Rhineland-Palatinate, 54470
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53119
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53123
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51065
GSK Investigational Site
Cottbus, Brandenburg, 03050
GSK Investigational Site
Dachau, Bavaria, 85221
GSK Investigational Site
Deggendorf, 94469
GSK Investigational Site
Deggingen, Baden-Wurttemberg, 73326
GSK Investigational Site
Delitzsch, Saxony, 04509
GSK Investigational Site
Dillingen an der Donau, Bavaria, 89407
GSK Investigational Site
Donaustauf, Bavaria, 93093
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44263
GSK Investigational Site
Duisburg, North Rhine-Westphalia, 47057
GSK Investigational Site
Düren, North Rhine-Westphalia, 52349
GSK Investigational Site
Essen, North Rhine-Westphalia, 45277
GSK Investigational Site
Essen, North Rhine-Westphalia, 45355
GSK Investigational Site
Frankenberg, Hesse, 35066
GSK Investigational Site
Frankfurt am Main, Hesse, 60389
GSK Investigational Site
Frankfurt am Main, Hesse, 60596
GSK Investigational Site
Freudenberg, North Rhine-Westphalia, 57258
GSK Investigational Site
Fulda, Hesse, 36039
GSK Investigational Site
Fuldatal, Hesse, 34233
GSK Investigational Site
Garmisch-Partenirchen, Bavaria, 82467
GSK Investigational Site
Gauting, Bavaria, 82131
GSK Investigational Site
Geesthacht, Schleswig-Holstein, 21502
GSK Investigational Site
Gelsenkirchen, North Rhine-Westphalia, 45879
GSK Investigational Site
Gera, Thuringia, 07548
GSK Investigational Site
Gummersbach, North Rhine-Westphalia, 51643
GSK Investigational Site
Hagen, North Rhine-Westphalia, 58089
GSK Investigational Site
Halberstadt, Saxony-Anhalt, 38820
GSK Investigational Site
Halle, Saxony-Anhalt, 06108
GSK Investigational Site
Hamburg, 22291
GSK Investigational Site
Hamburg, 22299
GSK Investigational Site
Hamburg, 22763
GSK Investigational Site
Hanover, Lower Saxony, 30167
GSK Investigational Site
Hanover, Lower Saxony, 30173
GSK Investigational Site
Hettstedt, Saxony-Anhalt, 06333
GSK Investigational Site
Kassel, Hesse, 34121
GSK Investigational Site
Kleve, North Rhine-Westphalia, 47533
GSK Investigational Site
Koblenz, Rhineland-Palatinate, 56068
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
Leonberg, Baden-Wurttemberg, 71229
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23558
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167
GSK Investigational Site
Marburg, Hesse, 35037
GSK Investigational Site
Munich, Bavaria, 80339
GSK Investigational Site
Munich, Bavaria, 80539
GSK Investigational Site
Neu-Isenburg, Hesse, 63263
GSK Investigational Site
Neu-Ulm, Bavaria, 89231
GSK Investigational Site
Neuss, North Rhine-Westphalia, 41462
GSK Investigational Site
Neuwied, Rhineland-Palatinate, 56564
GSK Investigational Site
Nuremberg, Bavaria, 90402
GSK Investigational Site
Offenbach, Hesse, 63071
GSK Investigational Site
Peine, Lower Saxony, 31224
GSK Investigational Site
Potsdam, Brandenburg, 14467
GSK Investigational Site
Potsdam, Brandenburg, 14469
GSK Investigational Site
Rathenow, Brandenburg, 14712
GSK Investigational Site
Ratingen, North Rhine-Westphalia, 40878
GSK Investigational Site
Reinfeld, Schleswig-Holstein, 23858
GSK Investigational Site
Rheine, North Rhine-Westphalia, 48431
GSK Investigational Site
Rodgau, Hesse, 63110
GSK Investigational Site
Rosenheim, Bavaria, 83022
GSK Investigational Site
Rüdersdorf, Brandenburg, 15562
GSK Investigational Site
Rüsselsheim am Main, Hesse, 65428
GSK Investigational Site
Saalfeld, Thuringia, 07318
GSK Investigational Site
Saarbrücken, Saarland, 66111
GSK Investigational Site
Schleswig, Schleswig-Holstein, 24837
GSK Investigational Site
Schmölln, Thuringia, 04626
GSK Investigational Site
Solingen, North Rhine-Westphalia, 42699
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70372
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70378
GSK Investigational Site
Teuchern, Saxony-Anhalt, 06682
GSK Investigational Site
Wallerfing, Bavaria, 94574
GSK Investigational Site
Wardenburg, Lower Saxony, 26203
GSK Investigational Site
Warendorf, North Rhine-Westphalia, 48231
GSK Investigational Site
Wiesloch, Baden-Wurttemberg, 69168
GSK Investigational Site
Wissen, Rhineland-Palatinate, 57537
GSK Investigational Site
Witten, North Rhine-Westphalia, 58452
GSK Investigational Site
Witten, 58452
GSK Investigational Site
Zerbst, Saxony-Anhalt, 39261

Other trials in Germany

Japan113 sites

GSK Investigational Site
Aichi, 455-8530
GSK Investigational Site
Aichi, 457-8510
GSK Investigational Site
Aichi, 457-8511
GSK Investigational Site
Aichi, 460-0001
GSK Investigational Site
Aichi, 471-8513
GSK Investigational Site
Aichi, 485-0041
GSK Investigational Site
Aichi, 489-8642
GSK Investigational Site
Chiba, 278-0004
GSK Investigational Site
Chiba, 296-8602
GSK Investigational Site
Ehime, 791-0281
GSK Investigational Site
Fukuoka, 802-0052
GSK Investigational Site
Fukuoka, 802-0083
GSK Investigational Site
Fukuoka, 811-1394
GSK Investigational Site
Fukuoka, 816-0813
GSK Investigational Site
Fukuoka, 820-8505
GSK Investigational Site
Fukuoka, 832-0059
GSK Investigational Site
Gifu, 500-8717
GSK Investigational Site
Gifu, 506-8550
GSK Investigational Site
Gifu, 509-6134
GSK Investigational Site
Gunma, 372-0831
GSK Investigational Site
Gunma, 373-0807
GSK Investigational Site
Hiroshima, 722-8503
GSK Investigational Site
Hiroshima, 734-8530
GSK Investigational Site
Hiroshima, 735-8585
GSK Investigational Site
Hokkaido, 001-0901
GSK Investigational Site
Hokkaido, 053-8506
GSK Investigational Site
Hokkaido, 060-0033
GSK Investigational Site
Hokkaido, 062-8618
GSK Investigational Site
Hokkaido, 063-0005
GSK Investigational Site
Hokkaido, 064-0801
GSK Investigational Site
Hokkaido, 064-0915
GSK Investigational Site
Hokkaido, 070-8644
GSK Investigational Site
Hokkaido, 071-8132
GSK Investigational Site
Hokkaido, 078-8211
GSK Investigational Site
Hokkaido, 080-0805
GSK Investigational Site
Hyōgo, 650-0047
GSK Investigational Site
Hyōgo, 651-0072
GSK Investigational Site
Hyōgo, 653-0013
GSK Investigational Site
Hyōgo, 664-8540
GSK Investigational Site
Hyōgo, 670-0849
GSK Investigational Site
Hyōgo, 672-8064
GSK Investigational Site
Hyōgo, 674-0063
GSK Investigational Site
Hyōgo, 675-8611
GSK Investigational Site
Ibaraki, 302-0022
GSK Investigational Site
Ibaraki, 310-0015
GSK Investigational Site
Ibaraki, 311-3193
GSK Investigational Site
Ibaraki, 317-0077
GSK Investigational Site
Ibaraki, 319-1113
GSK Investigational Site
Ishikawa, 920-8530
GSK Investigational Site
Ishikawa, 920-8610
GSK Investigational Site
Ishikawa, 921-8105
GSK Investigational Site
Ishikawa, 923-8560
GSK Investigational Site
Kagawa, 760-0018
GSK Investigational Site
Kagawa, 760-8538
GSK Investigational Site
Kagawa, 761-8073
GSK Investigational Site
Kagawa, 762-8550
GSK Investigational Site
Kanagawa, 210-0852
GSK Investigational Site
Kanagawa, 232-0024
GSK Investigational Site
Kanagawa, 232-0066
GSK Investigational Site
Kanagawa, 239-0821
GSK Investigational Site
Kanagawa, 252-5188
GSK Investigational Site
Kanagawa, 254-8502
GSK Investigational Site
Kochi, 780-8077
GSK Investigational Site
Kumamoto, 861-1196
GSK Investigational Site
Kyoto, 601-1495
GSK Investigational Site
Kyoto, 607-8062
GSK Investigational Site
Kyoto, 615-8087
GSK Investigational Site
Mie, 510-8567
GSK Investigational Site
Mie, 515-8544
GSK Investigational Site
Miyagi, 984-8560
GSK Investigational Site
Miyagi, 985-8506
GSK Investigational Site
Miyagi, 986-8522
GSK Investigational Site
Miyagi, 989-1253
GSK Investigational Site
Nagano, 392-8510
GSK Investigational Site
Niigata, 940-0856
GSK Investigational Site
Numakunai, 020-0055
GSK Investigational Site
Ōita, 870-0921
GSK Investigational Site
Okayama, 701-0304
GSK Investigational Site
Okayama, 702-8055
GSK Investigational Site
Okayama, 711-0921
GSK Investigational Site
Okinawa, 901-2121
GSK Investigational Site
Okinawa, 901-2132
GSK Investigational Site
Okinawa, 901-2393
GSK Investigational Site
Okinawa, 904-2143
GSK Investigational Site
Okinawa, 904-2293
GSK Investigational Site
Osaka, 530-0001
GSK Investigational Site
Osaka, 533-0024
GSK Investigational Site
Osaka, 559-0012
GSK Investigational Site
Osaka, 564-0013
GSK Investigational Site
Osaka, 576-0016
GSK Investigational Site
Osaka, 576-0041
GSK Investigational Site
Osaka, 591-8037
GSK Investigational Site
Osaka, 591-8555
GSK Investigational Site
Osaka, 596-8501
GSK Investigational Site
Saitama, 349-1105
GSK Investigational Site
Shizuoka, 420-8527
GSK Investigational Site
Shizuoka, 430-8525
GSK Investigational Site
Tochigi, 320-0065
GSK Investigational Site
Tokyo, 103-0027
GSK Investigational Site
Tokyo, 103-0028
GSK Investigational Site
Tokyo, 104-8560
GSK Investigational Site
Tokyo, 120-0033
GSK Investigational Site
Tokyo, 134-0083
GSK Investigational Site
Tokyo, 158-8531
GSK Investigational Site
Tokyo, 194-0023
GSK Investigational Site
Tokyo, 198-0042
GSK Investigational Site
Tokyo, 204-8585
GSK Investigational Site
Toyama, 937-0042
GSK Investigational Site
Toyama, 938-8502
GSK Investigational Site
Wakayama, 640-8558
GSK Investigational Site
Yamagata, 990-8533
GSK Investigational Site
Yamanashi, 400-0031
GSK Investigational Site
Yamanashi, 400-8506

Other trials in Japan

Spain54 sites

GSK Investigational Site
(Badalona) Barcelona, 08911
GSK Investigational Site
(Barakaldo) Vizcaya, 48903
GSK Investigational Site
A Coruña, 15006
GSK Investigational Site
A Coruña, 15011
GSK Investigational Site
Alicante, 03004
GSK Investigational Site
Alzira/Valencia, 46600
GSK Investigational Site
Badalona, Catalonia, 08916
GSK Investigational Site
Barcelona, 08003
GSK Investigational Site
Barcelona, 08006
GSK Investigational Site
Barcelona, 08017
GSK Investigational Site
Barcelona, 08023
GSK Investigational Site
Barcelona, 08028
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Barcelona, 08041
GSK Investigational Site
Basurto/Bilbao, 48013
GSK Investigational Site
Burgos, 09006
GSK Investigational Site
Cáceres, 10003
GSK Investigational Site
Centelles (Barcelona), 08540
GSK Investigational Site
Coslada, 28822
GSK Investigational Site
Girona, 17005
GSK Investigational Site
Girona, 17007
GSK Investigational Site
L'Hospitalet de Llobregat, 08907
GSK Investigational Site
La Roca Del Valles (Barcelona), 08430
GSK Investigational Site
Laredo, Cantabria, 39770
GSK Investigational Site
Lleida, 25198
GSK Investigational Site
Madrid, 28006
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Málaga, 29010
GSK Investigational Site
Marbella - Málaga, Andalusia, 29603
GSK Investigational Site
Mataró, 08303
GSK Investigational Site
Mérida (Badajoz), 06800
GSK Investigational Site
Oviedo, 33006
GSK Investigational Site
Palma de Mallorca, 07120
GSK Investigational Site
Pamplona, 31008
GSK Investigational Site
Peralada( Girona), 17491
GSK Investigational Site
Petrer/Alicante, 03610
GSK Investigational Site
Ponferrada (León), 24411
GSK Investigational Site
Pozuelo de Alarcón/Madrid, 28223
GSK Investigational Site
Sabadell (Barcelona), 08208
GSK Investigational Site
Sagunto/Valencia, 46520
GSK Investigational Site
Salamanca, 37007
GSK Investigational Site
San Sebastián de los Reyes, 28702
GSK Investigational Site
Sant Joan d'Alacant, 3550
GSK Investigational Site
Santander, 39008
GSK Investigational Site
Santiago de Compostela, 15706
GSK Investigational Site
Seville, 41013
GSK Investigational Site
Tarragona, 43002
GSK Investigational Site
Torrelavega, Cantabria, 39300
GSK Investigational Site
Valencia, 46015
GSK Investigational Site
Valencia, 46017
GSK Investigational Site
Valladolid, 47012
GSK Investigational Site
Vizcaya, 48902
GSK Investigational Site
Zaragoza, 50009

Other trials in Spain

China40 sites

GSK Investigational Site
Beijing, 100020
GSK Investigational Site
Beijing, 100029
GSK Investigational Site
Beijing, 100034
GSK Investigational Site
Beijing, 100050
GSK Investigational Site
Beijing, 100191
GSK Investigational Site
Changchun, Jilin, 130041
GSK Investigational Site
Changsha, 410013
GSK Investigational Site
Chengdu, Sichuan, 610041
GSK Investigational Site
Chongqing, 400037
GSK Investigational Site
Chongqing, 400038
GSK Investigational Site
Chongqing
GSK Investigational Site
Fuzhou, 350025
GSK Investigational Site
Guangzhou, Guangdong, 510080
GSK Investigational Site
Guangzhou, Guangdong, 510120
GSK Investigational Site
Guangzhou, Guangdong, 510150
GSK Investigational Site
Guangzhou, Guangdong, 510180
GSK Investigational Site
Guangzhou, Guangdong, 510630
GSK Investigational Site
Guangzhou, 510080
GSK Investigational Site
Haikou, Hainan, 570311
GSK Investigational Site
Hangzhou, Zhejiang
GSK Investigational Site
Jinan, Shandong, 250012
GSK Investigational Site
Jinan, Shandong, 250013
GSK Investigational Site
Nanchang, Jiangxi, 330006
GSK Investigational Site
Nanchang, 330006
GSK Investigational Site
Nanjing, Jiangsu, 210006
GSK Investigational Site
Nanjing, Jiangsu, 210008
GSK Investigational Site
Nanjing, Jiangsu, 210029
GSK Investigational Site
Nanning, Guangxi, 530021
GSK Investigational Site
Qingdao, Shandong, 266071
GSK Investigational Site
Shanghai, 200025
GSK Investigational Site
Shanghai, 200433
GSK Investigational Site
Shenyang, Liaoning, 110004
GSK Investigational Site
Shenyang, Liaoning, 110015
GSK Investigational Site
Shijiazhuang, Hebei, 050000
GSK Investigational Site
Taiyuan, Shanxi, 030001
GSK Investigational Site
Tianjin, 300052
GSK Investigational Site
Wuxi, 214023
GSK Investigational Site
Xian, Shanxi, 710032
GSK Investigational Site
Yinchuan, Ningxia, 750004
GSK Investigational Site
Zhanjiang, Guangdong, 524001

Other trials in China

Argentina37 sites

GSK Investigational Site
Bahía Blanca, Buenos Aires, B8000AAK
GSK Investigational Site
Berazategui, 1886
GSK Investigational Site
Berazategui, Buenos Aires, B1884AAC
GSK Investigational Site
Buenos Aires, C1120AAC
GSK Investigational Site
Buenos Aires, C1121ABE
GSK Investigational Site
Buenos Aires, C1128AAF
GSK Investigational Site
Buenos Aires, C1424BSF
GSK Investigational Site
Buenos Aires, C1425BEN
GSK Investigational Site
Buenos Aires, C1426ABP
GSK Investigational Site
CABA, Buenos Aires
GSK Investigational Site
Capital Federal, C1440BRR
GSK Investigational Site
Ciudad Autonoma de Buenis Aires, C1015ABR
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1028AAP
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1414AIF
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425AGC
GSK Investigational Site
Concepción del Uruguay, Entre Ríos Province, 3260
GSK Investigational Site
Córdoba, Córdoba Province, X5003DCE
GSK Investigational Site
Córdoba, 5000
GSK Investigational Site
Coronel Suárez, 7540
GSK Investigational Site
Florida, Buenos Aires, 1602
GSK Investigational Site
La Plata, Buenos Aires, 1900
GSK Investigational Site
Mar del Plata, Buenos Aires, 7600
GSK Investigational Site
Mar del Plata, Buenos Aires, B7600FZN
GSK Investigational Site
Mendoza, 5500
GSK Investigational Site
Mendoza, M5500CCG
GSK Investigational Site
Monte Grande, 1842
GSK Investigational Site
Nueve de Julio, Buenos Aires, B6500BWQ
GSK Investigational Site
Paraná, Buenos Aires, E3100BHK
GSK Investigational Site
Rosario, Santa Fe Province, 2000
GSK Investigational Site
Rosario, Santa Fe Province, S2002OJN
GSK Investigational Site
Salta, A4400ERH
GSK Investigational Site
San Miguel de Tucumán, Tucumán Province, 4000
GSK Investigational Site
San Miguel de Tucumán, 4000
GSK Investigational Site
San Rafael, Mendoza Province, 5600
GSK Investigational Site
Santa Fe, 3000
GSK Investigational Site
Santa Rosa, 6300
GSK Investigational Site
Vicente López, Buenos Aires, B1602DOH

Other trials in Argentina

Russia36 sites

GSK Investigational Site
Barnaul, 656038
GSK Investigational Site
Belgorod, 308007
GSK Investigational Site
Blagoveshchensk, 675000
GSK Investigational Site
Chita, 672000
GSK Investigational Site
Chita, 672090
GSK Investigational Site
Ivanovo, 153005
GSK Investigational Site
Kazan', 420012
GSK Investigational Site
Kazan', 420015
GSK Investigational Site
Krasnodar, 350012
GSK Investigational Site
Krasnoyarsk, 660022
GSK Investigational Site
Moscow, 119002
GSK Investigational Site
Moscow, 127018
GSK Investigational Site
Novosibirsk, 630087
GSK Investigational Site
Petrozavodsk, 185019
GSK Investigational Site
Pyatigorsk, 357538
GSK Investigational Site
Ryazan, 390005
GSK Investigational Site
Ryazan, 390039
GSK Investigational Site
Saint Petersburg, 194354
GSK Investigational Site
Saint Petersburg, 194356
GSK Investigational Site
Saint Petersburg, 198216
GSK Investigational Site
Saratov, 410053
GSK Investigational Site
Stavropol, 355017
GSK Investigational Site
Tomsk, 634009
GSK Investigational Site
Tomsk, 634050
GSK Investigational Site
Ulan-Ude, 670031
GSK Investigational Site
Ulyanovsk, 432063
GSK Investigational Site
Velikiy Novgorod, 173008
GSK Investigational Site
Vladimir, 600023
GSK Investigational Site
Vladivostok, 690002
GSK Investigational Site
Vladivostok, 690950
GSK Investigational Site
Volgodonsk, 347381
GSK Investigational Site
Voronezh, 394066
GSK Investigational Site
Vsevolozhsk, Leningrad Region, 188640
GSK Investigational Site
Yaroslavl, 150003
GSK Investigational Site
Yaroslavl, 150010
GSK Investigational Site
Yekaterinburg, 620109

Other trials in Russia

Canada26 sites

GSK Investigational Site
Burlington, Ontario, L7N 3V2
GSK Investigational Site
Cornwall, Ontario, K6H4M4
GSK Investigational Site
Edmonton, Alberta, T6G 2G3
GSK Investigational Site
Gatineau, Quebec, J8Y 6S8
GSK Investigational Site
Greater Sudbury, Ontario, P3A 1Y8
GSK Investigational Site
Greater Sudbury, Ontario, P3E 1H5
GSK Investigational Site
Hamilton, Ontario, L8L 5G8
GSK Investigational Site
Hamilton, Ontario, L8N 3Z5
GSK Investigational Site
Mirabel, Quebec, J7J 2K8
GSK Investigational Site
Moncton, New Brunswick, E1G 2K5
GSK Investigational Site
Montreal, Quebec, H1M 1B1
GSK Investigational Site
Québec, Quebec, G1V 4G5
GSK Investigational Site
Québec, Quebec, G3K 2P8
GSK Investigational Site
Saint-Charles-Borromée, Quebec, J6E 2B4
GSK Investigational Site
Sarnia, Ontario, N7T 4X3
GSK Investigational Site
Sherwood Park, Alberta, T8H 0N2
GSK Investigational Site
Toronto, Ontario, M3J 2C5
GSK Investigational Site
Toronto, Ontario, M4S 1Y2
GSK Investigational Site
Toronto, Ontario, M5T 3A9
GSK Investigational Site
Toronto, Ontario, M9C 4Z5
GSK Investigational Site
Toronto, Ontario, M9W 4L6
GSK Investigational Site
Trois-Rivières, Quebec, G8T 7A1
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2
GSK Investigational Site
Windsor, Ontario, N8X 5A6
GSK Investigational Site
Winnipeg, Manitoba, R2H 2A6
GSK Investigational Site
Winnipeg, Manitoba, R2K 3S8

Other trials in Canada

Netherlands24 sites

GSK Investigational Site
's-Hertogenbosch, 5223 GZ
GSK Investigational Site
Alkmaar, 1815 JD
GSK Investigational Site
Almelo, 7606 SB
GSK Investigational Site
Almelo, 7609 PP
GSK Investigational Site
Assen, 9401 RK
GSK Investigational Site
Beek, 6191 JW
GSK Investigational Site
Breda, 4818 CK
GSK Investigational Site
Dordrecht, 3318 AT
GSK Investigational Site
Eindhoven, 5623 EJ
GSK Investigational Site
Enschede, 7513 ER
GSK Investigational Site
Groningen, 9728 NT
GSK Investigational Site
Harderwijk, 3844 DG
GSK Investigational Site
Helmond, 5707 HA
GSK Investigational Site
Hoofddorp, 2134 TM
GSK Investigational Site
Hoorn, 1624 NP
GSK Investigational Site
Kloosterhaar, 7694 AC
GSK Investigational Site
Leeuwarden, 8934 AD
GSK Investigational Site
Nieuwegein, 3435 CM
GSK Investigational Site
Rotterdam, 3083 AN
GSK Investigational Site
Sneek, 8601 ZR
GSK Investigational Site
Spijkenisse, 3207 NB
GSK Investigational Site
Veldhoven, 5504 DB
GSK Investigational Site
Zutphen, 7207 AE
GSK Investigational Site
Zwolle, 8025 AB

Other trials in Netherlands

South Korea23 sites

GSK Investigational Site
Bucheon City, Gyenggi-do, 420-767
GSK Investigational Site
Cheongju-si, Chungcheongbuk-do, 361-763
GSK Investigational Site
Gyeonggi-do, 410-719
GSK Investigational Site
Gyeonggi-do, 431-796
GSK Investigational Site
Gyeonggi-do, 463-707
GSK Investigational Site
Incheon, 403-720
GSK Investigational Site
Incheon, 405-760
GSK Investigational Site
Jeonju, 561-712
GSK Investigational Site
Kangwon-do, 220-701
GSK Investigational Site
Seoul, 110-744
GSK Investigational Site
Seoul, 120-752
GSK Investigational Site
Seoul, 130-709
GSK Investigational Site
Seoul, 130-872
GSK Investigational Site
Seoul, 134-791
GSK Investigational Site
Seoul, 134-814
GSK Investigational Site
Seoul, 135-720
GSK Investigational Site
Seoul, 136-705
GSK Investigational Site
Seoul, 143-729
GSK Investigational Site
Seoul, 150-713
GSK Investigational Site
Seoul, 156-707
GSK Investigational Site
Seoul, 156-755
GSK Investigational Site
Seoul, 158-710
GSK Investigational Site
Suwon, 442-723

Other trials in South Korea

South Africa21 sites

GSK Investigational Site
Bellville, 7530
GSK Investigational Site
Benoni, Gauteng, 1501
GSK Investigational Site
Bloemfontein, 9301
GSK Investigational Site
Boksburg, Gauteng, 1459
GSK Investigational Site
Boksburg North, 1459
GSK Investigational Site
Cape Town, 7129
GSK Investigational Site
Cape Town, 7572
GSK Investigational Site
CapeTown, 7764
GSK Investigational Site
Durban, 4001
GSK Investigational Site
Durban, 4091
GSK Investigational Site
eManzimtoti, 4126
GSK Investigational Site
Gatesville, 7764
GSK Investigational Site
Johannesburg, 2113
GSK Investigational Site
Korsten, 6014
GSK Investigational Site
Middelburg, Mpumalanga, 1055
GSK Investigational Site
Mowbray, 7700
GSK Investigational Site
Paarl, 7646
GSK Investigational Site
Panorama, 7500
GSK Investigational Site
Pretoria, Gauteng, 0183
GSK Investigational Site
Tygerberg, 7505
GSK Investigational Site
Val de Grace, Pretoria, Gauteng, 0184

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France19 sites

GSK Investigational Site
Bayonne, 64109
GSK Investigational Site
Brest, 29609
GSK Investigational Site
Briis-sous-Forge, 91640
GSK Investigational Site
Grenoble, 38043
GSK Investigational Site
Le Mans, 72000
GSK Investigational Site
Lyon, 69317
GSK Investigational Site
Marseille, 13331
GSK Investigational Site
Montauban, 82017
GSK Investigational Site
Montpellier, 34295
GSK Investigational Site
Nîmes, 30900
GSK Investigational Site
Orléans, 45067
GSK Investigational Site
Paris, 75014
GSK Investigational Site
Perpignan, 66000
GSK Investigational Site
Pessac, 33604
GSK Investigational Site
Pringy, 74374
GSK Investigational Site
Rennes, 35033
GSK Investigational Site
Strasbourg, 67091
GSK Investigational Site
Toulon, 83000
GSK Investigational Site
Vandœuvre-lès-Nancy, 54511

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Australia16 sites

GSK Investigational Site
Adelaide, South Australia, 5000
GSK Investigational Site
Cairns, Queensland, 4870
GSK Investigational Site
Carina Heights, Queensland, 4152
GSK Investigational Site
Clayton, Victoria, 3168
GSK Investigational Site
Concord, New South Wales, 2139
GSK Investigational Site
Daw Park, South Australia, 5041
GSK Investigational Site
Footscray, Victoria, 3011
GSK Investigational Site
Frankston, Victoria, 3199
GSK Investigational Site
Geelong, Victoria, 3220
GSK Investigational Site
Gosford, New South Wales, 2250
GSK Investigational Site
Hamilton, Victoria, 3300
GSK Investigational Site
Liverpool, 2107
GSK Investigational Site
Maroubra, New South Wales, 2035
GSK Investigational Site
Murdoch, Western Australia, 6964
GSK Investigational Site
Nedlands, Western Australia, 6009
GSK Investigational Site
Westmead, New South Wales, 2145

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Chile16 sites

GSK Investigational Site
Concepción, Región Del Biobio, 4070038
GSK Investigational Site
Curicó, Maule Region, 3341643
GSK Investigational Site
Puente Alto - Santiago, Región Metro de Santiago, 8207257
GSK Investigational Site
Santiago, Región Metro de Santiago, 7500692
GSK Investigational Site
Santiago, Región Metro de Santiago, 7500710
GSK Investigational Site
Santiago, Región Metro de Santiago, 7510186
GSK Investigational Site
Santiago, Región Metro de Santiago, 7750495
GSK Investigational Site
Santiago, Región Metro de Santiago, 7860406
GSK Investigational Site
Santiago, Región Metro de Santiago, 8360160
GSK Investigational Site
Santiago, 7500698
GSK Investigational Site
Santiago, 8380453
GSK Investigational Site
Talca, Maule Region, 3465584
GSK Investigational Site
Talcahuano, 4270918
GSK Investigational Site
Valparaíso, Valparaiso, 2341131
GSK Investigational Site
Viña del Mar, Valparaiso, 2520024
GSK Investigational Site
Viña del Mar, 2520594

Other trials in Chile

United Kingdom16 sites

GSK Investigational Site
Baillieston, Glasgow, G69 7AD
GSK Investigational Site
Blackpool, Lancashire, FY3 7EN
GSK Investigational Site
Bradford, BD9 6RJ
GSK Investigational Site
Bradford on Avon, Wiltshire, BA15 1DQ
GSK Investigational Site
Cambridge, CB2 0QQ
GSK Investigational Site
Chester, CH2 1UL
GSK Investigational Site
Crawley, RH10 7DX
GSK Investigational Site
Crownhill, Plymouth, PL5 3JB
GSK Investigational Site
Dundee, Scotland, DD1 9SY
GSK Investigational Site
Exeter, Devon, EX2 5DW
GSK Investigational Site
High Heaton, Newcastle Upon Tyne, Tyne & Wear, NE7 7DN
GSK Investigational Site
Northwood, Middlesex, HA6 2RN
GSK Investigational Site
Sidcup, Kent, DA14 6LT
GSK Investigational Site
Stockton-on-Tees, TS19 8PE
GSK Investigational Site
Trowbridge, BA14 9AR
GSK Investigational Site
Wishaw, Lanarkshire, ML2 0DP

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Belgium15 sites

GSK Investigational Site
Antwerp, 2060
GSK Investigational Site
Bruges, 8000
GSK Investigational Site
Brussels, 1200
GSK Investigational Site
Erpent, 5101
GSK Investigational Site
Genk, 3600
GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Gilly, 6060
GSK Investigational Site
Hasselt, 3500
GSK Investigational Site
Liège, 4000
GSK Investigational Site
Malmedy, 4960
GSK Investigational Site
Mechelen, 2800
GSK Investigational Site
Montigny-le-Tilleul, 6110
GSK Investigational Site
Ostend, 8400
GSK Investigational Site
Roeselaere, 8800
GSK Investigational Site
Turnhout, 2300

Other trials in Belgium

Czechia15 sites

GSK Investigational Site
Benešov, 256 30
GSK Investigational Site
Brandýs nad Labem, 250 01
GSK Investigational Site
Cvikov, 471 54
GSK Investigational Site
Holešov, 769 01
GSK Investigational Site
Hradec Králové, 500 05
GSK Investigational Site
Jaroměř, 551 01
GSK Investigational Site
Olomouc, 772 00
GSK Investigational Site
Olomouc, 775 20
GSK Investigational Site
Ostrava - Poruba, 70868
GSK Investigational Site
Pilsen, 301 00
GSK Investigational Site
Prague, 150 06
GSK Investigational Site
Prague, 182 00
GSK Investigational Site
Tábor, 390 19
GSK Investigational Site
Teplice, 415 10
GSK Investigational Site
Třebíč, 674 01

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Israel13 sites

GSK Investigational Site
Afula, 18101
GSK Investigational Site
Ashkelon, 78278
GSK Investigational Site
Haifa, 34362
GSK Investigational Site
Holon, 58100
GSK Investigational Site
Jerusalem, 91031
GSK Investigational Site
Jerusalem, 91120
GSK Investigational Site
Kfar Saba, 44281
GSK Investigational Site
Petah Tikva, 49100
GSK Investigational Site
Ramat Gan, 52621
GSK Investigational Site
Rehovot, 76100
GSK Investigational Site
Tel Aviv, 64239
GSK Investigational Site
Tel Aviv, 67891
GSK Investigational Site
Zrifin, 70300

Other trials in Israel

Peru12 sites

GSK Investigational Site
Lima, 01
GSK Investigational Site
Lima, L 33
GSK Investigational Site
Lima, L41
GSK Investigational Site
Lima, Lima 14
GSK Investigational Site
Lima, Lima 18
GSK Investigational Site
Lima, Lima 1
GSK Investigational Site
Lima, Lima 27
GSK Investigational Site
Lima, Lima 32
GSK Investigational Site
Lima, Lima 41
GSK Investigational Site
Pueblo Libre, Lima region, Lima 21
GSK Investigational Site
San Martín de Porres, Lima region, Lima 31
GSK Investigational Site
San Miguel, Lima region, Lima 32

Other trials in Peru

Brazil11 sites

GSK Investigational Site
Blumenau, Santa Catarina, 89030-101
GSK Investigational Site
Florianópolis, Santa Catarina, 88040-970
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-074
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90480-000
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90610000
GSK Investigational Site
Recife, Pernambuco, 50920-900
GSK Investigational Site
Rio de Janeiro, 21941-913
GSK Investigational Site
São Paulo, 01323903
GSK Investigational Site
São Paulo, 04023900
GSK Investigational Site
São Paulo, 04266-010
GSK Investigational Site
São Paulo, 05403-000

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Sweden10 sites

GSK Investigational Site
Borås, SE-506 30
GSK Investigational Site
Gothenburg, SE-413 45
GSK Investigational Site
Gothenburg, SE-413 90
GSK Investigational Site
Höllviken, SE-236 32
GSK Investigational Site
Linköping, SE-587 58
GSK Investigational Site
Luleå, SE-971 89
GSK Investigational Site
Örebro, SE-703 62
GSK Investigational Site
Östersund, SE-831 83
GSK Investigational Site
Stockholm, SE-111 57
GSK Investigational Site
Uppsala, SE-752 37

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Ukraine10 sites

GSK Investigational Site
Kharkiv, 61002
GSK Investigational Site
Kharkiv, 61124
GSK Investigational Site
Kiev, 03680
GSK Investigational Site
Kyiv, 02232
GSK Investigational Site
Kyiv, 03049
GSK Investigational Site
Kyiv, 03680
GSK Investigational Site
Mykolayiv, 54003
GSK Investigational Site
Odesa, 65025
GSK Investigational Site
Sumy, 40022
GSK Investigational Site
Vinnytsia, 21000

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Norway9 sites

GSK Investigational Site
Bodø, 8005
GSK Investigational Site
Fredrikstad, 1606
GSK Investigational Site
Hakadal, 1487
GSK Investigational Site
Kløfta, 2040
GSK Investigational Site
Levanger, 7600
GSK Investigational Site
Oslo, 0953
GSK Investigational Site
Stavanger, 4005
GSK Investigational Site
Stavanger, 4011
GSK Investigational Site
Trondheim, 7027

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Denmark8 sites

GSK Investigational Site
Aalborg, 9100
GSK Investigational Site
Aarhus C, 8000
GSK Investigational Site
Hellerup, 2900
GSK Investigational Site
Hvidovre, 2650
GSK Investigational Site
Kolding, DK-6000
GSK Investigational Site
Odense C, 5000
GSK Investigational Site
Roskilde, 4000
GSK Investigational Site
Sønderborg, 6400

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Romania8 sites

GSK Investigational Site
Brăila, 810003
GSK Investigational Site
Brasov, 500283
GSK Investigational Site
Bucharest, 020125
GSK Investigational Site
Comuna Alexandru Cel Bun, 617507
GSK Investigational Site
Constanța, 900002
GSK Investigational Site
Ploieşti, 100184
GSK Investigational Site
Ploieşti, 100379
GSK Investigational Site
Râmnicu Vâlcea, 240564

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Thailand8 sites

GSK Investigational Site
Bangkok, 10330
GSK Investigational Site
Bangkok, 10600
GSK Investigational Site
Chiang Mai, 50200
GSK Investigational Site
Khon Kaen, 40002
GSK Investigational Site
Muang, 11000
GSK Investigational Site
Nakhon Ratchasima, 30000
GSK Investigational Site
Nan, 55000
GSK Investigational Site
Songkhla, 90110

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Finland7 sites

GSK Investigational Site
Espoo, 02740
GSK Investigational Site
Helsinki, 00290
GSK Investigational Site
Jyväskylä, 40100
GSK Investigational Site
Lohja, 08200
GSK Investigational Site
Tampere, 33520
GSK Investigational Site
Turku, 20100
GSK Investigational Site
Turku, 20520

Other trials in Finland

New Zealand6 sites

GSK Investigational Site
Auckland, 1051
GSK Investigational Site
Dunedin, 9012
GSK Investigational Site
Newtown, Wellington, 6021
GSK Investigational Site
Tauranga, 3110
GSK Investigational Site
Tauranga, 3112
GSK Investigational Site
Wellington, 6021

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Poland6 sites

GSK Investigational Site
Bialystok, 15-351
GSK Investigational Site
Ostrowiec Świętokrzyski, 27-400
GSK Investigational Site
Sopot, 81-741
GSK Investigational Site
Szczecin, 71-124
GSK Investigational Site
Tarnów, 33-100
GSK Investigational Site
Zgierz, 95-100

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Austria5 sites

GSK Investigational Site
Feldbach, 8330
GSK Investigational Site
Feldkirch, 6800
GSK Investigational Site
Grieskirchen, A-4710
GSK Investigational Site
Thalheim bei Wels, 4600
GSK Investigational Site
Vienna, A-1030

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Hong Kong5 sites

GSK Investigational Site
Kwun Tong
GSK Investigational Site
Lai Chi Kok
GSK Investigational Site
Pokfulam
GSK Investigational Site
Shatin
GSK Investigational Site
Tuenmen

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Philippines5 sites

GSK Investigational Site
Caloocan, 1400
GSK Investigational Site
Iloilo City, 5000
GSK Investigational Site
Jaro, Iloilo City, 5000
GSK Investigational Site
Pasig, 1605
GSK Investigational Site
Quezon City, 1100

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Puerto Rico5 sites

GSK Investigational Site
Guaynabo, 00968
GSK Investigational Site
Mayagüez, 00680
GSK Investigational Site
Ponce, 00716
GSK Investigational Site
San Juan, 00921
GSK Investigational Site
San Juan, 00927

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Turkey (Türkiye)5 sites

GSK Investigational Site
Ankara, 06100
GSK Investigational Site
Istanbul, 34020
GSK Investigational Site
Istanbul, 34844
GSK Investigational Site
Izmir, 35100
GSK Investigational Site
Mersin, 33343

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Colombia4 sites

GSK Investigational Site
Barranquilla
GSK Investigational Site
Bogotá, 80CO
GSK Investigational Site
Bogotá
GSK Investigational Site
Medellín

Other trials in Colombia

Singapore4 sites

GSK Investigational Site
Singapore, 117599
GSK Investigational Site
Singapore, 169856
GSK Investigational Site
Singapore, 529889
GSK Investigational Site
Singapore, 609606

Other trials in Singapore

Vietnam2 sites

GSK Investigational Site
Hà Nội, 10000
GSK Investigational Site
Ho Chi Minh City, 70000

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About this study

Official title: A Phase III, 52 Week, Randomized, Double-blind, 3-arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI With the Fixed Dose Dual Combinations of FF/VI and UMEC/VI, All Administered Once-daily in the Morning Via a Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease

The study evaluates the efficacy of fluticasone furoate/umeclidinium bromide/vilanterol (FF/UMEC/VI) to reduce the annual rate of moderate and severe exacerbations compared with dual therapy of FF/VI or UMEC/VI in subjects with COPD. Published studies which assessed the use of an 'open' triple therapy (use of Inhaled Corticosteroid [ICS]/ Long-acting Muscarinic Receptor Antagonists [LAMA])/ Long Acting Beta-Agonist [LABA] delivered via multiple inhalers) in moderate-severe COPD patients, reported improvements in lung function, Health Related Quality of Life (HRQoL), hospitalization rates and rescue medication use, compared to dual therapy (ICS/LABA) or LAMA alone. These studies have also shown similar safety profile with dual or monotherapy doses for periods of up to one year. Given the clinical experience with FF, UMEC and VI, and that the associated risks with these compounds are anticipated from their known pharmacology, the potential benefit of a new therapy option in patients with moderate to severe COPD supports the further development of the closed triple combination (delivered via one inhaler). In the current study subjects meeting all inclusion/exclusion criteria will complete 2-week run-in period; 52 week treatment period and a 1-week safety follow-up period. Eligible subjects will be randomized to one of the following double-blind treatment groups FF/UMEC/VI 100 micrograms (mcg)/62.5 mcg/25 mcg once daily (QD), FF/VI 100 mcg/25 mcg QD, or UMEC/VI 62.5 mcg/25 mcg QD

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: fluticasone furoate (FF), vilanterol (VI), umeclidinium bromide (UMEC)
Keywords: COPD, umeclidinium, fluticasone furoate, vilanterol, triple therapy, exacerbation
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fluticasone furoate (FF)Drug
FF will be available in combination as dry powder for inhalation as FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg and FF/VI 100 mcg/25 mcg
vilanterol (VI)Drug
VI will be available in combination as dry powder for inhalation as FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg, FF/VI 100 mcg/25 mcg and UMEC/VI 62.5 mcg/25 mcg
umeclidinium bromide (UMEC)Drug
UMEC will be available in combination as dry powder for inhalation as FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg, and UMEC/VI 62.5 mcg/25 mcg

Study groups in NCT02164513
Study group	Role	What they receive
fluticasone furoate/umeclidinium bromide/vilanterol	Experimental	Eligible Subjects completing 2-weeks run-in period will receive FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg QD (morning) for a period of 52 weeks via DPI Receives: Drug: fluticasone furoate (FF); Drug: vilanterol (VI); Drug: umeclidinium bromide (UMEC)
fluticasone furoate/vilanterol	Experimental	Eligible Subjects completing 2-weeks run-in period will receive FF/VI 100 mcg/25 mcg QD (morning) for a treatment period of 52 weeks via DPI) Receives: Drug: fluticasone furoate (FF); Drug: vilanterol (VI)
umeclidinium bromide/vilanterol	Experimental	Eligible Subjects completing 2-weeks run-in period will receive UMEC/VI 62.5 mcg/25 mcg QD (morning) for a treatment period of 52 weeks via DPI Receives: Drug: vilanterol (VI); Drug: umeclidinium bromide (UMEC)

What is being measured

The primary outcome is the main question the study is designed to answer.

Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI and FF/VI
The annual rate of moderate or severe COPD exacerbations which occurred during treatment was assessed. Moderate exacerbations were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death). Severe exacerbations were defined as exacerbations that required hospitalization or resulted in death. Analysis performed using a generalized linear model assuming a negative binomial distribution. ITT population was used which comprised of all randomized participants, excluding those who were randomized in error. Only those participants with non-missing co-variates were included in the analysis.
Measured: Up to Week 52

Secondary outcomes (6)

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1), at Week 52 Comparing FF/UMEC/VI With FF/VI
FEV1 was defined as the amount of air a person exhales in one second. Change from Baseline was calculated as the value of FEV1 at Week 52 minus the value at Baseline. Baseline for trough FEV1 was defined as Day 1 (Pre-dose). Only those participants with non-missing co-variates were included in the analysis. The analysis was performed using a Repeated measures model with covariates of treatment group, smoking status (Screening), geographical region, visit, Baseline, Baseline by visit and treatment group by visit interactions.
Measured: Baseline and Week 52
Change From Baseline in St. George's Respiratory Questionnaire for (SGRQ) Total Score at Week 52 Comparing FF/UMEC/VI With FF/VI
SGRQ is a disease specific-questionnaire, designed to measure impact of respiratory disease and its treatment on a COPD participant's Health Related Quality of Life (HRQoL). SGRQ contains 14 questions with total of 40 items grouped into three domains (Symptoms, Activity, and Impacts). The overall summary score along with scores for the individual domains of symptoms, activity and impacts were assessed. Score was calculated by summing the pre-assigned weights of answers, dividing by sum of maximum weights for items in SGRQ. Total scores ranged from 0 to 100. A decrease in score indicates improvement in HRQoL and higher score implies worse quality of life. Change from Baseline was calculated as total score at Week 52 minus value at Baseline. Baseline was defined as Day 1. Minimum clinically important difference (MCID) for this instrument is a 4-point improvement (decrease from Baseline). Only those participants with non-missing co-variates were included in the analysis.
Measured: Baseline and Week 52
Time to First On-treatment Moderate/Severe Exacerbation Comparing FF/UMEC/VI With FF/VI and With UMEC/VI
This measures the number of days, to the first onset of moderate or severe exacerbations. Moderate exacerbations, were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death). Severe exacerbations, were defined as exacerbations that required hospitalization or resulted in death. The Hazard ratio from Cox proportional hazards model with covariates of treatment group, sex, exacerbation history (<=1, >=2 moderate/severe), smoking status (Screening), geographical region and post-bronchodilator percent predicted FEV1 (Screening), have been reported. Only those participants with non-missing co-variates were included in the analysis. First quartile and median time to onset are taken from the Kaplan-Meier estimates. If <25% (and <50%) of participants experienced the event within a treatment then Q1 (and median) time to onset are displayed as NA (not applicable) for that treatment.
Measured: Up to Week 52
Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI in the Subset of Participants With a Blood Eosinophil Count >=150 Cells Per Microliter
The annual rate of moderate or severe COPD exacerbations during the treatment, for participants with blood eosinophil count >=150 cells per microliter , has been reported. Moderate exacerbations, were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death). Severe exacerbations were defined as exacerbations that required hospitalization or resulted in death. Only those participants with non-missing co-variates and non-missing eosinophil, at Baseline were included in the analysis.
Measured: Up to Week 52
Time to First On-treatment Moderate/Severe Exacerbation Comparing FF/UMEC/VI With UMEC/VI in the Subset of Particpants With a Blood Eosinophil Count >=150 Cells Per Microliter at Baseline
This measures the number of days, to the first onset of moderate or severe exacerbations for participants with blood eosinophil count >=150 cells per microliter, at Baseline has been reported. Moderate exacerbations, were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death). Severe exacerbations, were defined as exacerbations that required hospitalization or resulted in death. Only those participants with non-missing co-variates and non missing eosinophils at Baseline were included in the analysis. First quartile and median time to onset are taken from the Kaplan-Meier estimates. If <25% (and <50%) of participants experienced the event within a treatment then Q1 (and median) time to onset are displayed as NA (not applicable) for that treatment.
Measured: Up to Week 52
Annual Rate of On-treatment Severe Exacerbations Comparing FF/UMEC/VI With FF/VI and With UMEC/VI
The annual rate of severe COPD exacerbations during the treatment, has been reported. Severe exacerbations were defined as exacerbations that required hospitalization or resulted in death. The covariates of treatment group, sex, exacerbation history (<=1, >=2 moderate/severe), smoking status (Screening), geographical region and post-bronchodilator percent predicted FEV1 (Screening) were used. Only those participants with non-missing co-variates were included in the analysis
Measured: Up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 201417 Jul 2017

First posted16 Jun 2014 (estimated)
Study start30 Jun 2014
Primary completion17 Jul 2017
Study completion17 Jul 2017

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 (27)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: Double blind
Who is masked: Participant, Investigator
Enrolment: 10,355 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02164513
Sponsor's protocol ID: 116855
Status last verified: Aug 2018
First submitted: 12 Jun 2014
Last updated: 10 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Regard L, Paillasseur JL, Burgel PR, Roche N. Classification and regression trees to identify COPD subgroups in clinical trial populations: insights from the IMPACT trial. BMC Pulm Med. 2026 May 19;26(1):311. doi: 10.1186/s12890-026-04312-0.
PubMed 42157159
Deslee G, Russo H, Fabry-Vendrand C, Koskas D, Thabut G, Bell JP, Caplen M, Bhatt PD, Carioto J, Pyenson B, Burgel PR. Impact of Increased Use of Single-Inhaler Triple Therapies on COPD Exacerbation Rates, Mortality, and Total Costs: PROMETHEUS France. Int J Chron Obstruct Pulmon Dis. 2025 Nov 17;20:3753-3763. doi: 10.2147/COPD.S539055. eCollection 2025.
PubMed 41281771
Risebrough NA, Mursleen S, Ndirangu K, Shah D, Martin A, Schroeder M, Ismaila AS. The long-term clinical and economic benefits of treating advanced COPD patients with single-inhaler triple therapy in Quebec, Canada - The IMPACT trial. Respir Med. 2024 Sep;231:107694. doi: 10.1016/j.rmed.2024.107694. Epub 2024 Jun 4.
PubMed 38844004
Aggarwal B, Jones P, Casas A, Gomes M, Juthong S, Litewka D, Ong-Dela Cruz B, Ramirez-Venegas A, Sayiner A, van Hasselt J, Compton C, Tombs L, Weng S, Levy G. Association between Increased Risk of Pneumonia with ICS in COPD: A Continuous Variable Analysis of Patient Factors from the IMPACT Study. Pulm Ther. 2024 Jun;10(2):183-192. doi: 10.1007/s41030-024-00255-1. Epub 2024 Mar 6.
PubMed 38446336
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 37012070
Bardsley S, Criner GJ, Halpin DMG, Han MK, Hanania NA, Hill D, Lange P, Lipson DA, Martinez FJ, Midwinter D, Siler TM, Singh D, Wise RA, van Zyl-Smit RN, Berkman N. Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus dual therapy in current and former smokers with COPD: IMPACT trial post hoc analysis. Respir Med. 2022 Dec;205:107040. doi: 10.1016/j.rmed.2022.107040. Epub 2022 Nov 11.
PubMed 36470149
Dransfield MT, Criner GJ, Halpin DMG, Han MK, Hartley B, Kalhan R, Lange P, Lipson DA, Martinez FJ, Midwinter D, Singh D, Wise R, Kunisaki KM. Time-Dependent Risk of Cardiovascular Events Following an Exacerbation in Patients With Chronic Obstructive Pulmonary Disease: Post Hoc Analysis From the IMPACT Trial. J Am Heart Assoc. 2022 Sep 20;11(18):e024350. doi: 10.1161/JAHA.121.024350. Epub 2022 Sep 14.
PubMed 36102236
Thompson PJ, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Lipson DA, Maghzal GJ, Martinez FJ, Midwinter D, Singh D, Tombs L, Wise RA. Effect of chronic mucus hypersecretion on treatment responses to inhaled therapies in patients with chronic obstructive pulmonary disease: Post hoc analysis of the IMPACT trial. Respirology. 2022 Dec;27(12):1034-1044. doi: 10.1111/resp.14339. Epub 2022 Aug 15.
PubMed 35970518
Thomashow B, Stiegler M, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Lange P, Martinez FJ, Midwinter D, Singh D, Tabberer M, Wise RA, Lipson DA, Jones P. Higher COPD Assessment Test Score Associated With Greater Exacerbations Risk: A Post Hoc Analysis of the IMPACT Trial. Chronic Obstr Pulm Dis. 2022 Jan 27;9(1):68-79. doi: 10.15326/jcopdf.2021.0259.
PubMed 34972260
Bafadhel M, Barnes N, Bourke SC, Compton C, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Hartley B, Jones CE, Lange P, Lettis S, Lipson DA, Lomas DA, Martin N, Martinez FJ, Wise R, Singh D. A single blood eosinophil count measurement is as good as two for prediction of ICS treatment response in the IMPACT trial. Eur Respir J. 2021 Sep 23;58(3):2004522. doi: 10.1183/13993003.04522-2020. Print 2021 Sep. No abstract available.
PubMed 34385263
Singh D, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Lange P, Lettis S, Lipson DA, Mannino D, Martin N, Martinez FJ, Miller BE, Wise R, Zhu CQ, Lomas D. InforMing the PAthway of COPD Treatment (IMPACT) trial: fibrinogen levels predict risk of moderate or severe exacerbations. Respir Res. 2021 Apr 28;22(1):130. doi: 10.1186/s12931-021-01706-y.
PubMed 33910578
Halpin DMG, Criner GJ, Dransfield MT, Han MK, Hartley B, Harvey C, Jones CE, Kato M, Lange P, Lettis S, Lomas DA, Martinez FJ, Martin N, Singh D, Wise R, Zheng J, Lipson DA. Triple Versus Dual Combination Therapy in Chronic Obstructive Pulmonary Disease in Asian Countries: Analysis of the IMPACT Trial. Pulm Ther. 2021 Jun;7(1):101-118. doi: 10.1007/s41030-020-00136-3. Epub 2020 Nov 17.
PubMed 33201438
Bourdin A, Criner G, Devouassoux G, Dransfield M, Halpin DMG, Han MK, Jones CE, Kalhan R, Lange P, Lettis S, Lipson DA, Lomas DA, Echave-Sustaeta Maria-Tome JM, Martin N, Martinez FJ, Quasny H, Sail L, Siler TM, Singh D, Thomashow B, Watz H, Wise R, Hanania NA. InforMing the PAthway of COPD Treatment (IMPACT Trial) Single-Inhaler Triple Therapy (Fluticasone Furoate/Umeclidinium/Vilanterol) Versus Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol in Patients With COPD: Analysis of the Western Europe and North America Regions. Chronic Obstr Pulm Dis. 2021 Jan;8(1):76-90. doi: 10.15326/jcopdf.2020.0158.
PubMed 33156982
Zheng J, Zhong N, Wang C, Wei LP, Zhou XD, Zhao L, Dong Yuan Y, He B, Wu B, Du X, Song J, Lipson DA. Single inhaler triple therapy (FF/UMEC/VI) versus FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the China cohort in the IMPACT trial. Curr Med Res Opin. 2021 Jan;37(1):145-155. doi: 10.1080/03007995.2020.1844646. Epub 2020 Dec 7.
PubMed 33124900
Marin JM, Mateos L, Roldan J, Echave-Sustaeta JM, Pascual-Guardia S, Pardo MV, Velasco B, Jones CE, Kilbride S, Lipson DA. Efficacy of FF/UMEC/VI compared with FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the Spain cohort in IMPACT. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620963021. doi: 10.1177/1753466620963021.
PubMed 33121372

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The sponsor has not listed a contact. The official record may have more details.

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See locations

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, 52 Week, Randomized, Double-blind, 3-arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI With the Fixed Dose Dual Combinations of FF/VI and UMEC/VI, All Administered Once-daily in the Morning Via a Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT02164513
Acronym / sponsor ID: 116855
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD, umeclidinium, fluticasone furoate, vilanterol, triple therapy, exacerbation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 10,355 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 30 Jun 2014 (actual)
Primary completion: 17 Jul 2017 (actual)
Study completion: 17 Jul 2017 (actual)
First posted: 16 Jun 2014 (estimated)
Results: Posted 10 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
fluticasone furoate/umeclidinium bromide/vilanterol	Experimental	Drug: fluticasone furoate (FF), Drug: vilanterol (VI), Drug: umeclidinium bromide (UMEC)Eligible Subjects completing 2-weeks run-in period will receive FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg QD (morning) for a period of 52 weeks via DPI
fluticasone furoate/vilanterol	Experimental	Drug: fluticasone furoate (FF), Drug: vilanterol (VI)Eligible Subjects completing 2-weeks run-in period will receive FF/VI 100 mcg/25 mcg QD (morning) for a treatment period of 52 weeks via DPI)
umeclidinium bromide/vilanterol	Experimental	Drug: vilanterol (VI), Drug: umeclidinium bromide (UMEC)Eligible Subjects completing 2-weeks run-in period will receive UMEC/VI 62.5 mcg/25 mcg QD (morning) for a treatment period of 52 weeks via DPI

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Informed Consent: A signed and dated written informed consent prior to study participation
Type of subject: Outpatient
Age: Subjects 40 years of age or older at Visit 1
Gender: Male or female subjects. A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, > 45 years, in the absence of hormone replacement therapy OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to safety follow-up contact): Abstinence; Oral Contraceptive, either combined or progestogen alone; Injectable progestogen; Implants of levonorgestrel; Estrogenic vaginal ring; Percutaneous contraceptive patches; Intrauterine device (IUD) or intrauterine system (IUS); Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, "documented" refers to the outcome of the investigator's/designee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records. Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
COPD Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society

Key exclusion criteria (25 listed)

Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study
Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD)
Alpha1-antitrypsin deficiency: Subjects with Alpha1-antitrypsin deficiency as the underlying cause of COPD
Other respiratory disorders: Subjects with active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening

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 (FF)FF will be available in combination as dry powder for inhalation as FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg and FF/VI 100 mcg/25 mcg	Drug	fluticasone furoate/umeclidinium bromide/vilanterol, fluticasone furoate/vilanterol
vilanterol (VI)VI will be available in combination as dry powder for inhalation as FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg, FF/VI 100 mcg/25 mcg and UMEC/VI 62.5 mcg/25 mcg	Drug	fluticasone furoate/umeclidinium bromide/vilanterol, fluticasone furoate/vilanterol, umeclidinium bromide/vilanterol
umeclidinium bromide (UMEC)UMEC will be available in combination as dry powder for inhalation as FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg, and UMEC/VI 62.5 mcg/25 mcg	Drug	fluticasone furoate/umeclidinium bromide/vilanterol, umeclidinium bromide/vilanterol

Primary outcome

Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI and FF/VI
Time frame: Up to Week 52
The annual rate of moderate or severe COPD exacerbations which occurred during treatment was assessed. Moderate exacerbations were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death). Severe exacerbations were defined as exacerbations that required hospitalization or resulted in death. Analysis performed using a generalized linear model assuming a negative binomial distribution. ITT population was used which comprised of all randomized participants, excluding those who were randomized in error. Only those participants with non-missing co-variates were included in the analysis.

6 secondary outcomes

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1), at Week 52 Comparing FF/UMEC/VI With FF/VI
Time frame: Baseline and Week 52
Change From Baseline in St. George's Respiratory Questionnaire for (SGRQ) Total Score at Week 52 Comparing FF/UMEC/VI With FF/VI
Time frame: Baseline and Week 52
Time to First On-treatment Moderate/Severe Exacerbation Comparing FF/UMEC/VI With FF/VI and With UMEC/VI
Time frame: Up to Week 52
Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI in the Subset of Participants With a Blood Eosinophil Count >=150 Cells Per Microliter
Time frame: Up to Week 52
Time to First On-treatment Moderate/Severe Exacerbation Comparing FF/UMEC/VI With UMEC/VI in the Subset of Particpants With a Blood Eosinophil Count >=150 Cells Per Microliter at Baseline
Time frame: Up to Week 52
Annual Rate of On-treatment Severe Exacerbations Comparing FF/UMEC/VI With FF/VI and With UMEC/VI
Time frame: Up to Week 52

Results and safety

Results posted to the registry on 10 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FF/UMEC/VI	4,151	3,714
FF/VI	4,134	3,598
UMEC/VI	2,070	1,775

Primary outcome: Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI and FF/VI

Time frame: Up to Week 52. Least squares mean (95% Confidence Interval). Unit: Exacerbations per participant per year

Measure	FF/UMEC/VI n = 4145	FF/VI n = 4133	UMEC/VI n = 2069
Value	0.91 (0.87 to 0.95)	1.07 (1.02 to 1.12)	1.21 (1.14 to 1.29)

FF/UMEC/VI vs UMEC/VI: Rate ratio: 0.75 (95% CI 0.70 to 0.81), p <0.001, Negative binomial model
FF/UMEC/VI vs FF/VI: Rate ratio: 0.85 (95% CI 0.80 to 0.90), p <0.001, Negative binomial model

Population analysed: ITT Population.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: On-treatment Serious adverse events (SAEs) and Adverse events (AEs) are reported from the first dose of randomized medication up to Week 52.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FF/UMEC/VI 100/62.5/25	895 of 4,151 (21.6%)	1,389 of 4,151 (33.5%)	68 of 4,151
FF/VI 100/25	850 of 4,134 (20.6%)	1,278 of 4,134 (30.9%)	76 of 4,134
UMEC/VI 62.5/25	470 of 2,070 (22.7%)	596 of 2,070 (28.8%)	49 of 2,070

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42157159Regard L, Paillasseur JL, Burgel PR, Roche N. Classification and regression trees to identify COPD subgroups in clinical trial populations: insights from the IMPACT trial. BMC Pulm Med. 2026 May 19;26(1):311. doi: 10.1186/s12890-026-04312-0.
Derived from this study: PubMed 41281771Deslee G, Russo H, Fabry-Vendrand C, Koskas D, Thabut G, Bell JP, Caplen M, Bhatt PD, Carioto J, Pyenson B, Burgel PR. Impact of Increased Use of Single-Inhaler Triple Therapies on COPD Exacerbation Rates, Mortality, and Total Costs: PROMETHEUS France. Int J Chron Obstruct Pulmon Dis. 2025 Nov 17;20:3753-3763. doi: 10.2147/COPD.S539055. eCollection 2025.
Derived from this study: PubMed 38844004Risebrough NA, Mursleen S, Ndirangu K, Shah D, Martin A, Schroeder M, Ismaila AS. The long-term clinical and economic benefits of treating advanced COPD patients with single-inhaler triple therapy in Quebec, Canada - The IMPACT trial. Respir Med. 2024 Sep;231:107694. doi: 10.1016/j.rmed.2024.107694. Epub 2024 Jun 4.
Derived from this study: PubMed 38446336Aggarwal B, Jones P, Casas A, Gomes M, Juthong S, Litewka D, Ong-Dela Cruz B, Ramirez-Venegas A, Sayiner A, van Hasselt J, Compton C, Tombs L, Weng S, Levy G. Association between Increased Risk of Pneumonia with ICS in COPD: A Continuous Variable Analysis of Patient Factors from the IMPACT Study. Pulm Ther. 2024 Jun;10(2):183-192. doi: 10.1007/s41030-024-00255-1. Epub 2024 Mar 6.
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 36470149Bardsley S, Criner GJ, Halpin DMG, Han MK, Hanania NA, Hill D, Lange P, Lipson DA, Martinez FJ, Midwinter D, Siler TM, Singh D, Wise RA, van Zyl-Smit RN, Berkman N. Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus dual therapy in current and former smokers with COPD: IMPACT trial post hoc analysis. Respir Med. 2022 Dec;205:107040. doi: 10.1016/j.rmed.2022.107040. Epub 2022 Nov 11.
Derived from this study: PubMed 36102236Dransfield MT, Criner GJ, Halpin DMG, Han MK, Hartley B, Kalhan R, Lange P, Lipson DA, Martinez FJ, Midwinter D, Singh D, Wise R, Kunisaki KM. Time-Dependent Risk of Cardiovascular Events Following an Exacerbation in Patients With Chronic Obstructive Pulmonary Disease: Post Hoc Analysis From the IMPACT Trial. J Am Heart Assoc. 2022 Sep 20;11(18):e024350. doi: 10.1161/JAHA.121.024350. Epub 2022 Sep 14.
Derived from this study: PubMed 35970518Thompson PJ, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Lipson DA, Maghzal GJ, Martinez FJ, Midwinter D, Singh D, Tombs L, Wise RA. Effect of chronic mucus hypersecretion on treatment responses to inhaled therapies in patients with chronic obstructive pulmonary disease: Post hoc analysis of the IMPACT trial. Respirology. 2022 Dec;27(12):1034-1044. doi: 10.1111/resp.14339. Epub 2022 Aug 15.
Derived from this study: PubMed 34972260Thomashow B, Stiegler M, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Lange P, Martinez FJ, Midwinter D, Singh D, Tabberer M, Wise RA, Lipson DA, Jones P. Higher COPD Assessment Test Score Associated With Greater Exacerbations Risk: A Post Hoc Analysis of the IMPACT Trial. Chronic Obstr Pulm Dis. 2022 Jan 27;9(1):68-79. doi: 10.15326/jcopdf.2021.0259.
Derived from this study: PubMed 34385263Bafadhel M, Barnes N, Bourke SC, Compton C, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Hartley B, Jones CE, Lange P, Lettis S, Lipson DA, Lomas DA, Martin N, Martinez FJ, Wise R, Singh D. A single blood eosinophil count measurement is as good as two for prediction of ICS treatment response in the IMPACT trial. Eur Respir J. 2021 Sep 23;58(3):2004522. doi: 10.1183/13993003.04522-2020. Print 2021 Sep. No abstract available.
Derived from this study: PubMed 33910578Singh D, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Lange P, Lettis S, Lipson DA, Mannino D, Martin N, Martinez FJ, Miller BE, Wise R, Zhu CQ, Lomas D. InforMing the PAthway of COPD Treatment (IMPACT) trial: fibrinogen levels predict risk of moderate or severe exacerbations. Respir Res. 2021 Apr 28;22(1):130. doi: 10.1186/s12931-021-01706-y.
Derived from this study: PubMed 33201438Halpin DMG, Criner GJ, Dransfield MT, Han MK, Hartley B, Harvey C, Jones CE, Kato M, Lange P, Lettis S, Lomas DA, Martinez FJ, Martin N, Singh D, Wise R, Zheng J, Lipson DA. Triple Versus Dual Combination Therapy in Chronic Obstructive Pulmonary Disease in Asian Countries: Analysis of the IMPACT Trial. Pulm Ther. 2021 Jun;7(1):101-118. doi: 10.1007/s41030-020-00136-3. Epub 2020 Nov 17.

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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

998 sites in 37 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 25 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 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 998 sites in United States, Germany, Japan, Spain, China and 32 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. 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 10 Oct 2018). 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?

Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI and FF/VI (time frame: Up to Week 52). 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 NCT02164513, which also lists 27 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 10 Oct 2018.