A 12-week Study to Evaluate the 24 Hour Pulmonary Function of Fluticasone Furoate (FF)/Vilanterol Inhalation Powder (FF/VI Inhalation Powder) Once Daily Compared With Salmeterol/Fluticasone Propionate (FP) Inhalation Powder Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Overview
- Phase
- Phase 3
- Intervention
- Fluticasone Furoate 100mcg/Vilanterol 25mcg
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- GlaxoSmithKline
- Enrollment
- 528
- Locations
- 1
- Primary Endpoint
- Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol 100/25mcg once daily compared with Salmeterol/Fluticasone Propionate 50/500mcg twice daily over a 12-week treatmen period in subjects with COPD.
Detailed Description
This is a randomized, double-blind, double-dummy, multi-centre parallel group study. Subjects who meet the eligilibilty criteria at Screening and meet the randomization criteria at the end of a 2-week Run-In period will enter a 12-week Treatment period. There will be a 7-day Follow-up period after the treatment period.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
- •have been hospitalised or have been treated with oral corticosteroids or antibiotics for their COPD within the last 3 years prior to Screening (Visit 1)
Exclusion Criteria
- •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)
Arms & Interventions
Fluticasone Furoate/Vilanterol
Inhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA)
Intervention: Fluticasone Furoate 100mcg/Vilanterol 25mcg
Fluticasone Propionate/Salmeterol
Inhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA
Intervention: Fluticaosne Propionate 500mcg/Salmeterol 50mcg
Outcomes
Primary Outcomes
Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84
Time Frame: Baseline and 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 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.
Secondary Outcomes
- Time to Onset on Treatment Day 1(Day 1)
- Change From Baseline in Trough FEV1 on Treatment Day 85(Baseline and Day 85)