Study Evaluating the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A 12-week Study to Evaluate the 24-hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
512
6 countries
51
Brief Summary
The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI 100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily over a 12-week treatment period in subjects with 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 Mar 2011
Shorter than P25 for phase_3
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2011
CompletedStudy Start
First participant enrolled
March 18, 2011
CompletedFirst Posted
Study publicly available on registry
March 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 24, 2012
CompletedResults Posted
Study results publicly available
February 6, 2014
CompletedFebruary 15, 2018
January 1, 2018
10 months
March 17, 2011
May 30, 2013
January 18, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline Trough in 24-Hour Weighted Mean FEV1 on Treatment Day 84
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours post-dose on Treatment Day 84. Baseline trough FEV1 was calculated as the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value. Analysis of covariance (ANCOVA) was conducted with covariates for country, smoking status, reversibility, and Baseline FEV1.
Baseline (Day 1) and Day 84
Secondary Outcomes (1)
Time to Onset on Treatment Day 1
Baseline and Day 1
Study Arms (2)
Fluticasone Furoate / GW642444 (vilanterol)
EXPERIMENTALInhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA)
Fluticasone Propionate / salmeterol
ACTIVE COMPARATORInhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA)
Interventions
inhalation powder
inhalation powder
inhalation powder
inhalation powder
Eligibility Criteria
You may qualify if:
- Signed and dated written informed consent
- Male or females ≥ 40 years of age
- Established clinical history of COPD by ATS/ERS definition
- Females are eligible to enter and participate if of non-childbearing potential, or if of child bearing potential, has a negative serum pregnancy test at screening, and agrees to one of the acceptable contraceptive methods listed in protocol, used consistently and correctly
- Former or current smoker \> 10 pack years
- Post-albuterol spirometry criteria: FEV1/FVC ratio ≤ 0.70 and FEV1 ≤ 70% of predicted normal (NHANES III)
You may not qualify if:
- Current diagnosis of asthma
- Subjects with other respiratory disorders including active tuberculosis, α1-antitrypsin deficiency, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
- Lung volume reduction surgery within previous 12 months
- Clinically significant abnormalities not due to COPD by chest x-ray
- Hospitalized for poorly controlled COPD within 12 weeks of Screening
- Poorly controlled COPD 6 weeks prior to Screening, defined as acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician
- Lower respiratory infection requiring antibiotics 6 weeks prior to Screening
- Uncontrolled or clinically significant (in opinion of PI) cardiovascular, hypertension, neurological, psychiatric, renal, hepatic, immunological, endocrine, peptic ulcer disease, or hematological abnormalities
- Carcinoma not in complete remission for at least 5 years
- Subjects with history of hypersensitivity to study medications (e.g., beta-agonists, corticosteroid) or components of inhalation powder (e.g., lactose, magnesium stearate)
- Subjects with history of severe milk protein allergy that, in opinion of study physician, contraindicates subject's participation
- Known/suspected history of alcohol or drug abuse in the last 2 years
- Women who are pregnant or lactating or plan to become pregnant
- Subjects medically unable to withhold albuterol and/or ipratropium 4 hours prior to spirometry testing at each study visit
- Use of certain medications such as bronchodilators and corticosteroids for the protocol-specific times prior to Visit 1 (the Investigator will discuss the specific medications)
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (51)
GSK Investigational Site
Jasper, Alabama, 35501, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
DeLand, Florida, 32720, United States
GSK Investigational Site
Coeur d'Alene, Idaho, 83814, United States
GSK Investigational Site
Minneapolis, Minnesota, 55402, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73103, United States
GSK Investigational Site
Medford, Oregon, 97504, 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
Boerne, Texas, 78006, United States
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23552, Germany
GSK Investigational Site
Napoli, Campania, 80131, Italy
GSK Investigational Site
San Felice A Cancello Caserta, Campania, 81027, Italy
GSK Investigational Site
Telese Terme (BN), Campania, 82037, Italy
GSK Investigational Site
Parma, Emilia-Romagna, 43100, Italy
GSK Investigational Site
Rome, Lazio, 00185, Italy
GSK Investigational Site
Rozzano (MI), Lombardy, 20089, Italy
GSK Investigational Site
Cagliari, Sardinia, 09126, Italy
GSK Investigational Site
Palermo, Sicily, 90146, Italy
GSK Investigational Site
Torrette (AN), The Marches, 60126, Italy
GSK Investigational Site
Florence, Tuscany, 50134, Italy
GSK Investigational Site
Padua, Veneto, 35128, Italy
GSK Investigational Site
Benoni, Gauteng, 1501, South Africa
GSK Investigational Site
Bellville, 7531, South Africa
GSK Investigational Site
Bloemfontein, 9301, South Africa
GSK Investigational Site
Cape Town, 7572, South Africa
GSK Investigational Site
George, 6529, South Africa
GSK Investigational Site
Port Elizabeth, 6045, South Africa
GSK Investigational Site
Reiger Park, 1459, South Africa
GSK Investigational Site
Somerset West, 7130, South Africa
GSK Investigational Site
Thabazimbi, 0380, South Africa
GSK Investigational Site
Witbank, 1034, South Africa
GSK Investigational Site
Alicante, 03114, Spain
GSK Investigational Site
Córdoba, 14004, Spain
GSK Investigational Site
Lugo, 27003, Spain
GSK Investigational Site
Mérida (Badajoz), 06800, Spain
GSK Investigational Site
Ponferrada (León), 24411, Spain
GSK Investigational Site
Valladolid, 47005, Spain
GSK Investigational Site
Cherkassy, 18009, Ukraine
GSK Investigational Site
Donetsk, 83099, Ukraine
GSK Investigational Site
Kharkiv, 61002, Ukraine
GSK Investigational Site
Kharkiv, 61035, Ukraine
GSK Investigational Site
Kiev, 03680, Ukraine
GSK Investigational Site
Kyiv, 03038, Ukraine
GSK Investigational Site
Kyiv, 03049, Ukraine
GSK Investigational Site
Kyiv, 04107, Ukraine
GSK Investigational Site
Mykolayiv, 54003, Ukraine
GSK Investigational Site
Vinnytsia, 21018, Ukraine
Related Publications (1)
Dransfield MT, Feldman G, Korenblat P, LaForce CF, Locantore N, Pistolesi M, Watkins ML, Crim C, Martinez FJ. Efficacy and safety of once-daily fluticasone furoate/vilanterol (100/25 mcg) versus twice-daily fluticasone propionate/salmeterol (250/50 mcg) in COPD patients. Respir Med. 2014 Aug;108(8):1171-9. doi: 10.1016/j.rmed.2014.05.008. Epub 2014 Jun 19.
PMID: 24998880DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
March 17, 2011
First Posted
March 25, 2011
Study Start
March 18, 2011
Primary Completion
January 1, 2012
Study Completion
January 24, 2012
Last Updated
February 15, 2018
Results First Posted
February 6, 2014
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.