Study to Evaluate 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
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
519
6 countries
50
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
50 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
December 14, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2011
CompletedResults Posted
Study results publicly available
July 30, 2013
CompletedNovember 8, 2017
October 1, 2017
9 months
March 17, 2011
May 30, 2013
October 9, 2017
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). 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 on Treatment Day 84. Baseline trough FEV1 was 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.
Baseline (Day 1) and Day 84
Secondary Outcomes (1)
Time to Onset on Treatment Day 1
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
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 (50)
GSK Investigational Site
Los Angeles, California, 90048, United States
GSK Investigational Site
Orlando, Florida, 32822, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Madisonville, Kentucky, 42431, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Charlotte, North Carolina, 28207, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Columbus, Ohio, 43215, United States
GSK Investigational Site
Easley, South Carolina, 29640, United States
GSK Investigational Site
Greenville, South Carolina, 29615, United States
GSK Investigational Site
Union, South Carolina, 29379, United States
GSK Investigational Site
Waco, Texas, 76712, United States
GSK Investigational Site
Benešov, 256 30, Czechia
GSK Investigational Site
Blansko, 678 31, Czechia
GSK Investigational Site
Kroměříž, 767 55, Czechia
GSK Investigational Site
Kyjov, 697 33, Czechia
GSK Investigational Site
Mělník, 276 01, Czechia
GSK Investigational Site
Nový Jičín, 741 01, Czechia
GSK Investigational Site
Rokycany, 337 01, Czechia
GSK Investigational Site
Třebíč, 674 01, Czechia
GSK Investigational Site
Frankfurt am Main, Hesse, 60596, Germany
GSK Investigational Site
Wiesbaden, Hesse, 65183, Germany
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19055, Germany
GSK Investigational Site
Berlin, 10717, Germany
GSK Investigational Site
Berlin, 10787, Germany
GSK Investigational Site
Berlin, 14057, Germany
GSK Investigational Site
Działdowo, 13-200, Poland
GSK Investigational Site
Elblag, 82-300, Poland
GSK Investigational Site
Inowrocław, 88-100, Poland
GSK Investigational Site
Katowice, 40-018, Poland
GSK Investigational Site
Krakow, 31-159, Poland
GSK Investigational Site
Poznan, 60-214, Poland
GSK Investigational Site
Wroclaw, 54-239, Poland
GSK Investigational Site
Brasov, 500112, Romania
GSK Investigational Site
Brasov, 500283, Romania
GSK Investigational Site
Bucharest, 011794, Romania
GSK Investigational Site
Bucharest, 030317, Romania
GSK Investigational Site
Bucharest, 050159, Romania
GSK Investigational Site
Bucharest, 70000, Romania
GSK Investigational Site
Cluj-Napoca, 400371, Romania
GSK Investigational Site
Iași, 700115, Romania
GSK Investigational Site
Suceava, 720284, Romania
GSK Investigational Site
Timișoara, 300310, Romania
GSK Investigational Site
Barnaul, 656024, Russia
GSK Investigational Site
Barnaul, 656038, Russia
GSK Investigational Site
Kaluga, 248007, Russia
GSK Investigational Site
Kemerovo, 650002, Russia
GSK Investigational Site
Kursk, 305035, Russia
GSK Investigational Site
Moscow, 125367, Russia
GSK Investigational Site
Saint Petersburg, 194291, Russia
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
December 14, 2011
Study Completion
December 14, 2011
Last Updated
November 8, 2017
Results First Posted
July 30, 2013
Record last verified: 2017-10
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.