Efficacy and Safety Study of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A 24-Week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components Delivered Once Daily (AM) Via a Novel Dry Powder Inhaler Compared With Placebo in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
1,226
9 countries
149
Brief Summary
The Purpose of this study is to assess the efficacy and safety of two strengths of the FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2009
Shorter than P25 for phase_3
149 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 19, 2009
CompletedFirst Submitted
Initial submission to the registry
January 14, 2010
CompletedFirst Posted
Study publicly available on registry
January 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2011
CompletedResults Posted
Study results publicly available
August 15, 2013
CompletedJanuary 24, 2018
January 1, 2018
1.3 years
January 14, 2010
June 12, 2013
January 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours (h) Post-dose at Day 168
Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Serial FEV1 measurements were taken electronically by spirometry at BL, weeks 2, 8, 12, and 84 (Day 168). Weighted mean (WM) was calculated using the 0 - 4 h post-dose FEV1 measurements that included the pre-dose (Day 1: 30 minutes \[min\] and 5 min prior to dosing; other serial visits:23 and 24 h after previous morning dose) and post-dose (5, 15, and 30 min and 1, 2, and 4 h) assessments. BL FEV1 is the mean of the two assessments made 30 and 5 min pre-dose at Day 1. WM change from BL was the WM at the visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL- mean of the two assessments made 30 and 5 min pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.
Baseline (BL) to Day 168
Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169
Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 7, 14, 28, 56, 84, 112, 140, 168, and 169. BL was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.
Baseline to Day 169
Secondary Outcomes (3)
Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Score at Day 168
Baseline to Day 168
Change From Baseline in Peak Post-dose FEV1 (0-4 Hour) on Day 1
Baseline and Day 1
Time to Onset (Increase of 100 Milliliter [mL] From Baseline in 0-4 Hours Post-dose FEV1) on Treatment Day 1
Baseline and Day 1
Study Arms (6)
Fluticasone Furoate Inhalation Powder
EXPERIMENTALInhaled Corticosteroid (ICS)
FF Inhalation Pwdr
EXPERIMENTALInhaled Corticosteroid (ICS)
Fluticasone Furoate/GW642444 Inhalation Powder
EXPERIMENTALInhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
FF/GW642444 Inhalation Pwdr
EXPERIMENTALInhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
GW642444 Inhalation Powder
EXPERIMENTALLong Acting Beta Agonist(LABA)
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Inhaled Corticosteroid (ICS)
Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) for COPD
Eligibility Criteria
You may qualify if:
- 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 OR
- Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the acceptable contraceptive methods defined in the protocol
- Age: ≥40 years of age at Screening (Visit 1)
- COPD diagnosis: Subjects with a clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society \[Celli, 2004\]
- Tobacco use: Subjects with a current or prior history of ≥10 pack-years of cigarette smoking at Screening (Visit 1).
- Severity of Disease: Subjects with a Screening (Visit 1) measured post-albuterol/salbutamol:
- FEV1/FVC ratio of ≤0.70 and
- FEV1 ≤70% of predicted normal values
- Dyspnea: Achieved a score of ≥2 on the Modified Medical Research Council Dyspnea Scale (mMRC) at Screening (Visit 1).
You may not qualify if:
- 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
- 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)
- 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.
- Hospitalization: Subjects who are hospitalized due to poorly controlled COPD within 12 weeks of Visit 1.
- Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the occurrence of the following in the 6 weeks prior to Visit 1: Acute worsening of COPD that is managed by subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician.
- Lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Visit 1.
- 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.
- 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 medication or components of the inhalation powder
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (149)
GSK Investigational Site
Birmingham, Alabama, 35235, United States
GSK Investigational Site
Jasper, Alabama, 35501, United States
GSK Investigational Site
Lakewood, California, 90712, United States
GSK Investigational Site
Long Beach, California, 90808, United States
GSK Investigational Site
Los Angeles, California, 90048, United States
GSK Investigational Site
Monterey Park, California, 91754, United States
GSK Investigational Site
National City, California, 91950, United States
GSK Investigational Site
Oxnard, California, 93030-5841, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
Santa Monica, California, 90404, United States
GSK Investigational Site
Wilmington, Delaware, 19805, United States
GSK Investigational Site
Bay Pines, Florida, 33744, United States
GSK Investigational Site
Brandon, Florida, 33511, United States
GSK Investigational Site
Clearwater, Florida, 33756, United States
GSK Investigational Site
Cocoa, Florida, 32927, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33316, United States
GSK Investigational Site
Pensacola, Florida, 32503, United States
GSK Investigational Site
Decatur, Georgia, United States
GSK Investigational Site
Gainesville, Georgia, United States
GSK Investigational Site
Martinez, Georgia, 30907, United States
GSK Investigational Site
Lenexa, Kansas, 66215, United States
GSK Investigational Site
Wheaton, Maryland, 20902, United States
GSK Investigational Site
Saint Charles, Missouri, 63301, United States
GSK Investigational Site
Cherry Hill, New Jersey, 08003, United States
GSK Investigational Site
Ocean City, New Jersey, 7712, United States
GSK Investigational Site
Brooklyn, New York, 11229, United States
GSK Investigational Site
Elizabeth City, North Carolina, 27909, United States
GSK Investigational Site
Statesville, North Carolina, 28625, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Dayton, Ohio, 45439, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73103, United States
GSK Investigational Site
Tulsa, Oklahoma, 74136-8303, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Portland, Oregon, 97213, United States
GSK Investigational Site
Columbia, South Carolina, 29203, United States
GSK Investigational Site
Easley, South Carolina, 29640, United States
GSK Investigational Site
Gaffney, South Carolina, 29340, United States
GSK Investigational Site
Orangeburg, South Carolina, 29118, United States
GSK Investigational Site
Seneca, South Carolina, 29678, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Union, South Carolina, 29379, United States
GSK Investigational Site
Johnson City, Tennessee, 37601, United States
GSK Investigational Site
New Tazewell, Tennessee, 37825, United States
GSK Investigational Site
Boerne, Texas, 78006, United States
GSK Investigational Site
Corsicana, Texas, 75110, United States
GSK Investigational Site
Kingwood, Texas, 77339, United States
GSK Investigational Site
Temple, Texas, 76508, United States
GSK Investigational Site
Fredericksburg, Virginia, 22401, United States
GSK Investigational Site
Morgantown, West Virginia, 26505, United States
GSK Investigational Site
Cipolletti, Río Negro Province, R8324EMB, Argentina
GSK Investigational Site
Buenos Aires, C1121ABE, Argentina
GSK Investigational Site
Buenos Aires, C1425BEN, Argentina
GSK Investigational Site
San Miguel de Tucumán, 4000, Argentina
GSK Investigational Site
Brno, 625 00, Czechia
GSK Investigational Site
Jindřichův Hradec, 377 01, Czechia
GSK Investigational Site
Kralupy nad Vltavou, 278 01, Czechia
GSK Investigational Site
Liberec, 460 01, Czechia
GSK Investigational Site
Ostrava - Poruba, 70868, Czechia
GSK Investigational Site
Pilsen, 301 00, Czechia
GSK Investigational Site
Pilsen, 323 00, Czechia
GSK Investigational Site
Prague, 180 81, Czechia
GSK Investigational Site
Prague, 182 00, Czechia
GSK Investigational Site
Rokycany, 337 01, Czechia
GSK Investigational Site
Tábor, 390 19, Czechia
GSK Investigational Site
Munich, Bavaria, 80339, Germany
GSK Investigational Site
Darmstadt, Hesse, 64287, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60389, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60596, Germany
GSK Investigational Site
Gelnhausen, Hesse, 63571, Germany
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19055, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51069, Germany
GSK Investigational Site
Rhaunen, Rhineland-Palatinate, 55624, Germany
GSK Investigational Site
Dresden, Saxony, 01307, Germany
GSK Investigational Site
Leipzg, Saxony, 04109, Germany
GSK Investigational Site
Radebeul, Saxony, 01445, Germany
GSK Investigational Site
Geesthacht, Schleswig-Holstein, 21502, Germany
GSK Investigational Site
Berlin, 10117, Germany
GSK Investigational Site
Berlin, 10367, Germany
GSK Investigational Site
Berlin, 10717, Germany
GSK Investigational Site
Berlin, 10787, Germany
GSK Investigational Site
Berlin, 12043, Germany
GSK Investigational Site
Berlin, 12203, Germany
GSK Investigational Site
Berlin, 13086, Germany
GSK Investigational Site
Berlin, 13125, Germany
GSK Investigational Site
Berlin, 13581, Germany
GSK Investigational Site
Berlin, 14057, Germany
GSK Investigational Site
Hamburg, 22143, Germany
GSK Investigational Site
Hamburg, 22299, Germany
GSK Investigational Site
Hamburg, 22335, Germany
GSK Investigational Site
Chiba, 296-8602, Japan
GSK Investigational Site
Ehime, 791-0281, Japan
GSK Investigational Site
Fukuoka, 811-3195, Japan
GSK Investigational Site
Ibaraki, 306-0433, Japan
GSK Investigational Site
Kyoto, 602-8026, Japan
GSK Investigational Site
Kyoto, 612-0026, Japan
GSK Investigational Site
Mie, 514-1101, Japan
GSK Investigational Site
Okinawa, 901-2132, Japan
GSK Investigational Site
Okinawa, 904-2143, Japan
GSK Investigational Site
Osaka, 530-0001, Japan
GSK Investigational Site
Osaka, 591-8555, Japan
GSK Investigational Site
Shizuoka, 434-8511, Japan
GSK Investigational Site
Tokyo, 158-0083, Japan
GSK Investigational Site
Częstochowa, 42-200, Poland
GSK Investigational Site
Gdansk, 80-952, Poland
GSK Investigational Site
Gidle, 97-540, Poland
GSK Investigational Site
Giżycko, 11-500, Poland
GSK Investigational Site
Piekary Śląskie, 41-940, Poland
GSK Investigational Site
Szczecin, 71-124, Poland
GSK Investigational Site
Warsaw, 01-138, Poland
GSK Investigational Site
Warsaw, 02-097, Poland
GSK Investigational Site
Łomża, 18-400, Poland
GSK Investigational Site
Brasov, 500112, Romania
GSK Investigational Site
Bucharest, 010816, Romania
GSK Investigational Site
Bucharest, 011794, Romania
GSK Investigational Site
Bucharest, 020125, Romania
GSK Investigational Site
Bucharest, 020201, Romania
GSK Investigational Site
Bucharest, 030317, Romania
GSK Investigational Site
Bucharest, 031298, Romania
GSK Investigational Site
Bucharest, 050159, Romania
GSK Investigational Site
Bucharest, 70000, Romania
GSK Investigational Site
Cluj-Napoca, 400349, Romania
GSK Investigational Site
Cluj-Napoca, 400371, Romania
GSK Investigational Site
Constanța, 900002, Romania
GSK Investigational Site
Deva, 330160, Romania
GSK Investigational Site
Iași, 700115, Romania
GSK Investigational Site
Popeşti-Leordeni, 077160, Romania
GSK Investigational Site
Suceava, 720284, Romania
GSK Investigational Site
Timișoara, 300310, Romania
GSK Investigational Site
Chelyabinsk, 454106, Russia
GSK Investigational Site
Ivanovo, 153005, Russia
GSK Investigational Site
Kazan', 420015, Russia
GSK Investigational Site
Kemerovo, 650000, Russia
GSK Investigational Site
Krasnoyarsk, 660022, Russia
GSK Investigational Site
Moscow, 105077, Russia
GSK Investigational Site
Moscow, 119 048, Russia
GSK Investigational Site
Moscow, 127018, Russia
GSK Investigational Site
Saint Petersburg, 193231, Russia
GSK Investigational Site
Saint Petersburg, 194354, Russia
GSK Investigational Site
Yaroslavl, Russia
GSK Investigational Site
Dnipropetrovsk, 49051, Ukraine
GSK Investigational Site
Kharkiv, 61035, Ukraine
GSK Investigational Site
Kiev, 03680, Ukraine
GSK Investigational Site
Kyiv, 01114, Ukraine
GSK Investigational Site
Kyiv, 02091, Ukraine
GSK Investigational Site
Kyiv, 03038, Ukraine
GSK Investigational Site
Kyiv, 03115, Ukraine
GSK Investigational Site
Odesa, 65117, Ukraine
GSK Investigational Site
Simferopol, 95043, Ukraine
GSK Investigational Site
Vinnytsia, 21029, Ukraine
Related Publications (3)
Martinez FJ, Boscia J, Feldman G, Scott-Wilson C, Kilbride S, Fabbri L, Crim C, Calverley PM. Fluticasone furoate/vilanterol (100/25; 200/25 mug) improves lung function in COPD: a randomised trial. Respir Med. 2013 Apr;107(4):550-9. doi: 10.1016/j.rmed.2012.12.016. Epub 2013 Jan 16.
PMID: 23332861BACKGROUNDYang L, Llanos-Paez C, Yang S, Ambery C, Berges A, Kjellsson MC, Karlsson MO. A Combined Model-Based Meta-Analysis of Aggregated and Individual FEV1 Data From Randomized COPD Trials. CPT Pharmacometrics Syst Pharmacol. 2026 Feb;15(2):e70059. doi: 10.1002/psp4.70059. Epub 2025 Jun 19.
PMID: 40536286DERIVEDSvedsater 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.
PMID: 24314123DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2010
First Posted
January 22, 2010
Study Start
October 19, 2009
Primary Completion
February 1, 2011
Study Completion
February 8, 2011
Last Updated
January 24, 2018
Results First Posted
August 15, 2013
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.