AzTrials
AzTrials

Pulmonary Disease, Chronic ObstructivePhase 3NCT01009463

A Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing FF/GW642444 Inhalation Powder and GW642444 Inhalation Powder in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 188 sites in 15 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

The Purpose of this study is to assess the efficacy and safety of three strengths of the FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD) Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
FF/GW642444 Inhalation Powder and GW642444 Inhalation Powder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,626 participants
Where
188 sitesin 15 countries
Study dates
25 Sep 2009to 31 Oct 2011
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

  • Type of subject: outpatient
  • Informed consent: Subjects must give their signed and dated written informed consent to participate.
  • 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, history of vasomotor symptoms. However in questionable cases, a blood sample with FSH > 40MIU/ml and estradiol <40pg/ml (<140 pmol/L) is confirmatory. 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 follow-up contact):
  • Complete abstinence from intercourse from screening until the Follow-Up Phone Contact; or
  • Male partner is sterile (vasectomy with documentation of azoospermia) prior to female subject entry into the study, and this male partner is the sole partner for that subject; or
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  • Implants of levonorgestral inserted for at least 1 month prior to the study medication administration but not beyond the third successive year following insertion; or
  • Injectable progestogen administered for at least 1 month prior to study medication administration and administered until the Follow-Up Phone Contact; or
  • Oral contraceptive (combined or progestogen only) administered for at least one monthly cycle prior to study medication administration; or
  • Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository); or
  • An intrauterine device (IUD), inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year; or
  • Estrogenic vaginal ring; or
  • Percutaneous contraceptive patches
  • Age: ≥40 years of age at Screening (Visit 1)
  • COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]: COPD is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.
  • Tobacco use: Subjects with a current or prior history of ≥10 pack-years of cigarette smoking at Screening (Visit 1). Former 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. Number of pack years = (number of cigarettes per day/20) x number of years smoked
  • Severity of Disease:
  • Subject with a measured post-albuterol/salbutamol FEV1/FVC ratio of ≤0.70 at Screening (Visit 1)
  • Subjects with a measured post-albuterol/salbutamol FEV1 <70% of predicted normal values calculated (via centralized vendor equipment) using NHANES III reference equations [Hankinson, 1999] at Screening (Visit 1). Post-bronchodilator spirometry will be performed approximately 10-15 minutes after the subject has self-administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via an MDI with a valved-holding chamber. The study provided central spirometry equipment will calculate the FEV1/FVC ratio and FEV1 percent predicted values.
  • History of Exacerbations: A documented history (e.g., medical record verification) of at least one COPD exacerbation in the 12 months prior to Visit 1 that required either oral corticosteroids, antibiotics and/or hospitalization. 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.

Who cannot join

  • Subjects meeting any of the following criteria must not be enrolled in the study:
  • 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)
  • α1-antitrypsin deficiency: Subjects with α1-antitrypsin deficiency as the underlying cause of COPD
  • Other respiratory disorders: Subjects with active tuberculosis, lung cancer, 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 (Visit 1)
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  • Chest X-ray (or CT scan): Subjects with a chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray must be taken at Screening (Visit 1) if a chest X-ray or CT scan is not available within 6 months prior to Visit 1. For sites in Germany, if a chest X-ray (or CT scan) is not available in the 6 months preceding Screening (Visit 1), the subject will not be eligible for the study.
  • Risk Factors for Pneumonia: immune suppression (HIV, Lupus, etc) or other risk for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's, Myasthenia Gravis, etc).
  • A moderate and severe COPD exacerbation that has not resolved at least 14 days prior to Visit 1 and at least 30 days following the last dose of oral corticosteroids (if applicable).
  • Pneumonia and/or moderate and severe COPD exacerbation at Visit 1 Note: Subjects who experience a pneumonia and/or exacerbation at Screening (Visit 1) must be not continue in the study, but may be re-screened at a later time provided the pneumonia and/or COPD exacerbation has resolved prior to the re-screening visit. At the Re-screening Visit, the chest x-ray should confirm resolution of pneumonia. The Re-screening Visit must be conducted at least ≥ 14 days following the resolution date of the exacerbation and/or pneumonia and at least 30 days following the last dose of oral corticosteroids (if applicable).
  • Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular (i.e., pacemaker), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological 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.
  • Peptic Ulcer disease: Subjects with clinically significant peptic ulcer disease that is uncontrolled.
  • Hypertension: Subjects with clinically significant hypertension that is uncontrolled.
  • Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis.
  • Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g., beta-agonists, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subject's participation will also be excluded.
  • Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years
  • Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol and/or their ipratropium for the 4-hour period required prior to spirometry testing at each study visit.
  • Additional medication: Unable to stop using certain medications such as bronchodilators and corticosteroids for the protocol-specified times prior to Visit 1 (the Investigator will discuss the specific medications)
  • Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e., ≤12 hours per day) is not exclusionary.
  • Sleep apnea: Subjects with clinically significant sleep apnea who require use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.
  • Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening (Visit 1) or who will 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.
  • 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.
  • Prior use of study medication/other investigational drugs: Subjects who have previously been randomized to treatment with GW642444 Inhalation Powder in the B2C111045 study, randomized to treatment in the HZC111348 study or have participated in the HZC112207, HZC102871, HZC102970, or HZC110946 studies. Subjects who have received an investigational drug within 30 days of entry into this study (Screening), or within 5 drug half-lives of the investigational drug, whichever is longer.
  • Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.

Trial locations and contacts

188 sites in 15 countries.

188 sites in 15 countries

United States94 sites

  • GSK Investigational Site

    Abingdon, Virginia, 24210

  • GSK Investigational Site

    Anderson, South Carolina, 29621

  • GSK Investigational Site

    Austell, Georgia, 30106

  • GSK Investigational Site

    Austin, Texas, 78705

  • GSK Investigational Site

    Avon, Indiana, 46123

  • GSK Investigational Site

    Bay Pines, Florida, 33744

  • GSK Investigational Site

    Belleville, Illinois, 62220

  • GSK Investigational Site

    Billings, Montana, 59102

  • GSK Investigational Site

    Birmingham, Alabama, 35235

  • GSK Investigational Site

    Birmingham, Alabama, 35294

  • GSK Investigational Site

    Boerne, Texas, 78006

  • GSK Investigational Site

    Charleston, South Carolina, 29406-7108

  • GSK Investigational Site

    Charlottesville, Virginia, 22911

  • GSK Investigational Site

    Chattanooga, Tennessee, 37421

  • GSK Investigational Site

    Chester, South Carolina, 29706

  • GSK Investigational Site

    Chula Vista, California, 91911

  • GSK Investigational Site

    Clearwater, Florida, 33755

  • GSK Investigational Site

    Clearwater, Florida, 33756

  • GSK Investigational Site

    Columbia, Maryland, 21044

  • GSK Investigational Site

    Dayton, Ohio, 45406

  • GSK Investigational Site

    Decatur, Georgia

  • GSK Investigational Site

    Elizabeth City, North Carolina, 27909

  • GSK Investigational Site

    Fort Myers, Florida, 33916

  • GSK Investigational Site

    Fort Worth, Texas, 76109

  • GSK Investigational Site

    Fredericksburg, Virginia, 22401

  • GSK Investigational Site

    Gaffney, South Carolina, 29340

  • GSK Investigational Site

    Gainesville, Florida, 32608

  • GSK Investigational Site

    Greenwood, South Carolina, 29646

  • GSK Investigational Site

    Greer, South Carolina, 29651

  • GSK Investigational Site

    Iowa City, Iowa, 52242

  • GSK Investigational Site

    Jasper, Alabama, 35501

  • GSK Investigational Site

    Johnston, Rhode Island, 02919

  • GSK Investigational Site

    Kingwood, Texas, 77339

  • GSK Investigational Site

    Lafayette, Indiana, 47904

  • GSK Investigational Site

    Lake Jackson, Texas, 77566

  • GSK Investigational Site

    Lakewood, Washington, 98499

  • GSK Investigational Site

    Lawrenceville, Georgia, 30046

  • GSK Investigational Site

    Lebanon, New Hampshire, 03756

  • GSK Investigational Site

    Lenexa, Kansas, 66215

  • GSK Investigational Site

    Lincoln, California, 95648

  • GSK Investigational Site

    Long Beach, California, 90822

  • GSK Investigational Site

    Los Angeles, California, 90048

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    Minneapolis, Minnesota, 55402

  • GSK Investigational Site

    Minneapolis, Minnesota, 55407

  • GSK Investigational Site

    Mission Viejo, California, 92691

  • GSK Investigational Site

    Muncie, Indiana, 47304-5547

  • GSK Investigational Site

    Munfordville, Kentucky, 42765

  • GSK Investigational Site

    New Orleans, Louisiana, 70115

  • GSK Investigational Site

    New Tazewell, Tennessee, 37824-1409

  • GSK Investigational Site

    New York, New York, 10004

  • GSK Investigational Site

    New York, New York, 10029

  • GSK Investigational Site

    Newburgh, Indiana, 47630

  • GSK Investigational Site

    Ocean City, New Jersey, 7712

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73103

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73120

  • GSK Investigational Site

    Orlando, Florida, 32822

  • GSK Investigational Site

    Ormond Beach, Florida, 32174

  • GSK Investigational Site

    Owensboro, Kentucky, 42301

  • GSK Investigational Site

    Palo Alto, California, 94304

  • GSK Investigational Site

    Peoria, Arizona, 85381

  • GSK Investigational Site

    Phoenix, Arizona, 85012

  • GSK Investigational Site

    Phoenix, Arizona, 85050

  • GSK Investigational Site

    Plymouth, Minnesota, 55441

  • GSK Investigational Site

    Poway, California, 92064

  • GSK Investigational Site

    Rancho Mirage, California, 92270

  • GSK Investigational Site

    Richmond, Virginia, 23225

  • GSK Investigational Site

    River Forest, Illinois, 60305

  • GSK Investigational Site

    Riverside, California, 92506

  • GSK Investigational Site

    Rolling Hills Estates, California, 90274

  • GSK Investigational Site

    Saint Charles, Missouri, 63301

  • GSK Investigational Site

    Saint Joseph, Michigan, 49085

  • GSK Investigational Site

    Salisbury, North Carolina, 28144

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    Santa Monica, California, 90404

  • GSK Investigational Site

    Scottsdale, Arizona, 85258

  • GSK Investigational Site

    Sellersville, Pennsylvania, 18960

  • GSK Investigational Site

    Seneca, South Carolina, 29678

  • GSK Investigational Site

    Sepulveda, California, 91343

  • GSK Investigational Site

    South Burlington, Vermont, 05403

  • GSK Investigational Site

    Southfield, Michigan, 48034

  • GSK Investigational Site

    Spokane, Washington, 99204

  • GSK Investigational Site

    Stamford, Connecticut, 06902

  • GSK Investigational Site

    Sunset, Louisiana, 70584

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Tamarac, Florida, 33321

  • GSK Investigational Site

    Temple, Texas, 76508

  • GSK Investigational Site

    Torrance, California, 90503

  • GSK Investigational Site

    Tulsa, Oklahoma, 74136-8303

  • GSK Investigational Site

    Virginia Beach, Virginia, 23455

  • GSK Investigational Site

    Wenatchee, Washington, 98801

  • GSK Investigational Site

    Wichita, Kansas, 67205

  • GSK Investigational Site

    Winter Park, Florida, 32792

Other trials in United States

South Africa14 sites

  • GSK Investigational Site

    Boksburg North, 1459

  • GSK Investigational Site

    Cape Town, Gauteng, 7505

  • GSK Investigational Site

    Cape Town, 8001

  • GSK Investigational Site

    Durban, 4001

  • GSK Investigational Site

    Durban, 4091

  • GSK Investigational Site

    Groenkloof, 0181

  • GSK Investigational Site

    Lynnwood Manor, 0081

  • GSK Investigational Site

    Lyttleton, 0140

  • GSK Investigational Site

    Mueckelneck, Gauteng, 0001

  • GSK Investigational Site

    Paarl, 7646

  • GSK Investigational Site

    Panorama, 7500

  • GSK Investigational Site

    Reiger Park, 1459

  • GSK Investigational Site

    Somerset West, 7130

  • GSK Investigational Site

    Witbank, 1034

Other trials in South Africa

Netherlands12 sites

  • GSK Investigational Site

    Bunnik, 3981 LB

  • GSK Investigational Site

    Enschede, 7513 ER

  • GSK Investigational Site

    Etten-Leur, 4872 LA

  • GSK Investigational Site

    Harderwijk, 3844 DG

  • GSK Investigational Site

    Heerlen, 6419 PC

  • GSK Investigational Site

    Helmond, 5707 HA

  • GSK Investigational Site

    Nijverdal, 7442 LS

  • GSK Investigational Site

    Rotterdam, 3078 HT

  • GSK Investigational Site

    Sneek, 8601 ZK

  • GSK Investigational Site

    Spijkenisse, 3207 NB

  • GSK Investigational Site

    Veldhoven, 5504 DB

  • GSK Investigational Site

    Voerendaal, 6367 ED

Other trials in Netherlands

Canada10 sites

  • GSK Investigational Site

    Burlington, Ontario, L7N 3V2

  • GSK Investigational Site

    Corunna, Ontario, N0N 1G0

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3E 1H5

  • GSK Investigational Site

    Montreal, Quebec, H2R 1V6

  • GSK Investigational Site

    Québec, Quebec, G1V 4G5

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1E 2E2

  • GSK Investigational Site

    Toronto, Ontario, M3H 5S4

  • GSK Investigational Site

    Toronto, Ontario, M4P 1P2

  • GSK Investigational Site

    Toronto, Ontario, M9W 4L6

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 4E1

Other trials in Canada

Italy10 sites

  • GSK Investigational Site

    Cassano Murge (BA), Apulia, 70020

  • GSK Investigational Site

    Eboli (SA), Campania, 84025

  • GSK Investigational Site

    Ferrara, Emilia-Romagna, 44100

  • GSK Investigational Site

    Genoa, Liguria, 16132

  • GSK Investigational Site

    Milan, Lombardy, 20142

  • GSK Investigational Site

    Rome, Lazio, 00135

  • GSK Investigational Site

    Rome, Lazio, 00163

  • GSK Investigational Site

    Telese Terme (BN), Campania, 82037

  • GSK Investigational Site

    Torrette (AN), The Marches, 60126

  • GSK Investigational Site

    Tradate (VA), Lombardy, 21049

Other trials in Italy

Australia8 sites

  • GSK Investigational Site

    Cairns, Queensland, 4870

  • GSK Investigational Site

    Daw Park, South Australia, 5041

  • GSK Investigational Site

    Frankston, Victoria, 3199

  • GSK Investigational Site

    Garran, Australian Capital Territory, 2606

  • GSK Investigational Site

    Geelong, Victoria, 3220

  • GSK Investigational Site

    Heidelberg, Victoria, 3084

  • GSK Investigational Site

    Kippa-Ring, Queensland, 4021

  • GSK Investigational Site

    Nedlands, Western Australia, 6009

Other trials in Australia

Argentina6 sites

  • GSK Investigational Site

    Buenos Aires, C1424BSF

  • GSK Investigational Site

    Buenos Aires, C1425BEN

  • GSK Investigational Site

    Buenos Aires, C1426ABP

  • GSK Investigational Site

    Buenos Aires, C1428DDE

  • GSK Investigational Site

    Cipolletti, Río Negro Province, R8324EMB

  • GSK Investigational Site

    Mendoza, M5500CCG

Other trials in Argentina

United Kingdom6 sites

  • GSK Investigational Site

    Doncaster, DN9 2HY

  • GSK Investigational Site

    High Heaton, Newcastle Upon Tyne, Tyne & Wear, NE7 7DN

  • GSK Investigational Site

    Liverpool, L9 7AL

  • GSK Investigational Site

    London, E7 8QP

  • GSK Investigational Site

    London, NW3 2PF

  • GSK Investigational Site

    London, SW17 0RE

Other trials in United Kingdom

Sweden5 sites

  • GSK Investigational Site

    Gothenburg, SE-412 63

  • GSK Investigational Site

    Gothenburg, SE-413 45

  • GSK Investigational Site

    Höllviken, SE-236 51

  • GSK Investigational Site

    Kil, SE-665 30

  • GSK Investigational Site

    Örebro, SE-703 62

Other trials in Sweden

Estonia4 sites

  • GSK Investigational Site

    Rakvere, 44316

  • GSK Investigational Site

    Tallinn, 10117

  • GSK Investigational Site

    Tallinn, 10611

  • GSK Investigational Site

    Tartu, 51014

Other trials in Estonia

Germany4 sites

  • GSK Investigational Site

    Berlin, 10367

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 12203

  • GSK Investigational Site

    Geesthacht, Schleswig-Holstein, 21502

Other trials in Germany

Mexico4 sites

  • GSK Investigational Site

    Guadalajara, Jalisco, 44100

  • GSK Investigational Site

    Monterrey, Nuevo León, 64060

  • GSK Investigational Site

    Tijuana, Baja California Norte, 22320

  • GSK Investigational Site

    Zapopan, Jalisco, 45040

Other trials in Mexico

Peru4 sites

  • GSK Investigational Site

    Jesus Maria, Lima region, Lima 11

  • GSK Investigational Site

    Lima, Lima 27

  • GSK Investigational Site

    Lima, Lima 41

  • GSK Investigational Site

    San Martín de Porres, Lima region, Lima 31

Other trials in Peru

Philippines4 sites

  • GSK Investigational Site

    Dagupan, 2400

  • GSK Investigational Site

    Quezon City, 1100

  • GSK Investigational Site

    Quezon City, 1101

  • GSK Investigational Site

    Quezon City, 1109

Other trials in Philippines

Chile3 sites

  • GSK Investigational Site

    Santiago, 8380453

  • GSK Investigational Site

    Temuco, Región de La Araucania, 4800798

  • GSK Investigational Site

    Valparaíso, Valparaiso, 2341131

Other trials in Chile

About this study

Official title: HZC102871: A 52-week Efficacy and Safety Study to Compare the Effect of Three Dosage Strengths of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on the Annual Rate of Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

The Purpose of this study is to assess the efficacy and safety of three strengths of the FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)

Being tested
FF/GW642444 Inhalation Powder, GW642444 Inhalation Powder
Keywords
COPD, Safety, FEV1, Efficacy
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.

  • FF/GW642444 Inhalation PowderDrug

    Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) delivered within one dry powder inhaler (DPI) device for COPD

  • GW642444 Inhalation PowderDrug

    Long Acting Beta Agonist(LABA) Inhalation Powder via DPI

Study groups in NCT01009463
Study groupRoleWhat they receive
FF/GW642444 Inhalation Powder 100/25 mcg QDExperimentalInhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
Receives: Drug: FF/GW642444 Inhalation Powder
FF/GW642444 Inhalation Powder 200/25 mcg QDExperimentalInhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
Receives: Drug: FF/GW642444 Inhalation Powder
FF/GW642444 Inhalation Powder 50mcg/25mcg QDExperimentalInhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
Receives: Drug: FF/GW642444 Inhalation Powder
GW642444 25mcg QDExperimentalLong Acting Beta Agonist(LABA)
Receives: Drug: GW642444 Inhalation Powder

What is being measured

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

  1. Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean

    The annual rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations during the treatment (trt) period (per participant [par.] per year) was assessed. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the par. without the use of oral corticosteroids or antibiotics; Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics; Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.

    Measured: From the start of the double blinded study medication until Visit 11 (Week 52)/Early Withdrawal

Secondary outcomes (3)

  1. Time to First Occurrence of Moderate or Severe COPD Exacerbation

    Time to first occurrence analyzed by using a Cox proportional hazards model with covariates of treatment, smoking status at screening (stratum), baseline disease severity (pre-dose Day 1 % predicted FEV1) and centre grouping. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. A moderate exacerbation is defined as worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. A severe exacerbation is defined as worsening symptoms of COPD that required treatment with in-patient hospitalization. The number of participants with a moderate or severe COPD exacerbation while on treatment are presented.

    Measured: From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal

  2. Annual Rate of Exacerbations Requiring Systemic/Oral Corticosteroids Expressed as Least Square Mean

    The annual rate of COPD exacerbations during the treatment period (per participant per year) that required systemic/oral corticosteroids was assessed. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptom (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate, and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the participant. Mild exacerbations were not associated with the use of oral corticosteroids or antibiotics. Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.

    Measured: From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal

  3. Change From Baseline in Trough FEV1 at Week 52 (Visit 11)

    Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour post-dose FEV1 assessment, which was obtained at each visit. Analysis performed using a repeated measures model with covariates of treatment, smoking status at Screening (stratum), baseline (pre-dose Day 1), centre grouping, Week, Week by Baseline, and Week by treatment interactions.

    Measured: Baseline to Visit 11 (Week 52)/Early Withdrawal

Timeline

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

  1. First posted6 Nov 2009 (estimated)
  2. Study start25 Sep 2009
  3. Primary completion1 Oct 2011
  4. Study completion31 Oct 2011

Resources

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
1,626 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01009463
Sponsor's protocol ID
102871
Status last verified
Oct 2017
First submitted
5 Nov 2009
Last updated
9 Nov 2017
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Dransfield MT, Bourbeau J, Jones PW, Hanania NA, Mahler DA, Vestbo J, Wachtel A, Martinez FJ, Barnhart F, Sanford L, Lettis S, Crim C, Calverley PM. Once-daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD: two replicate double-blind, parallel-group, randomised controlled trials. Lancet Respir Med. 2013 May;1(3):210-23. doi: 10.1016/S2213-2600(13)70040-7. Epub 2013 Apr 12.

    PubMed 24429127

  • Largajolli A, Beerahee M, Yang S. Bayesian approach to investigate a two-state mixed model of COPD exacerbations. J Pharmacokinet Pharmacodyn. 2019 Aug;46(4):371-384. doi: 10.1007/s10928-019-09643-6. Epub 2019 Jun 13.

    PubMed 31197640

  • Hinds DR, DiSantostefano RL, Le HV, Pascoe S. Identification of responders to inhaled corticosteroids in a chronic obstructive pulmonary disease population using cluster analysis. BMJ Open. 2016 Jun 1;6(6):e010099. doi: 10.1136/bmjopen-2015-010099.

    PubMed 27251682

  • Crim C, Dransfield MT, Bourbeau J, Jones PW, Hanania NA, Mahler DA, Vestbo J, Wachtel A, Martinez FJ, Barnhart F, Lettis S, Calverley PM. Pneumonia risk with inhaled fluticasone furoate and vilanterol compared with vilanterol alone in patients with COPD. Ann Am Thorac Soc. 2015 Jan;12(1):27-34. doi: 10.1513/AnnalsATS.201409-413OC.

    PubMed 25490706

  • Svedsater H, Dale P, Garrill K, Walker R, Woepse MW. Qualitative assessment of attributes and ease of use of the ELLIPTA dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med. 2013 Dec 7;13:72. doi: 10.1186/1471-2466-13-72.

    PubMed 24314123

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FF/GW642444 Inhalation Powder and GW642444 Inhalation Powder in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 188 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 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 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 188 sites in United States, South Africa, Netherlands, Canada, Italy and 10 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 19 Aug 2013). 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 Moderate and Severe COPD Exacerbations Expressed as Least Square Mean (time frame: From the start of the double blinded study medication until Visit 11 (Week 52)/Early Withdrawal). 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 NCT01009463, which also lists 5 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 9 Nov 2017.

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