At a glance
ClinicalIndex Comparison Record- ✓Age ≥40 years at screening
- ✓Clinical diagnosis of COPD per ATS/ERS definition
- ✓Post-albuterol FEV1/FVC ratio ≤0.70 and FEV1 30-70% predicted using Global Lung Function Initiative 2012 reference equations
- ✓Current or prior history of ≥10 pack-years cigarette smoking; former smokers must have stopped ≥6 months prior to Visit 1
- ✕Current diagnosis of asthma (prior asthma history allowed if current COPD diagnosis)
- ✕Alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis (except focal), sarcoidosis, pulmonary fibrosis (except focal lesions), primary pulmonary hypertension, interstitial lung disease, or other active pulmonary disease
- ✕Lung volume reduction surgery within 12 months prior to screening
- ✕Chest X-ray or CT scan showing clinically significant abnormalities not believed due to COPD
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 12-Week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder (FF/VI) 100/25 mcg Once Daily Compared With Vilanterol Inhalation Powder (VI) 25 mcg Once Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 3 clinical trial evaluating Fluticasone Furoate/Vilanterol and Vilanterol for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 1,621 participants across 237 sites in 11 countries.
Detailed Summary
This is a Phase IIIa, multicenter, randomized, stratified (reversibility status), double-blind, parallel-group study to evaluate the efficacy and safety of FF/VI 100/25 micrograms (mcg) once daily (QD) compared with VI 25 mcg QD, administered in the morning via the ELLIPTA™ inhaler. The primary objective of this study is to evaluate the contribution on lung function (as measured by trough forced expiratory volume in one second \[FEV1\]) of FF 100 mcg to the FF/VI 100/25 mcg QD combination by comparison of the latter with VI 25 mcg QD and the safety of FF/VI 100/25 mcg over a 12-week treatment period in subjects with COPD. ELLIPTA™ is a registered trademark of GlaxoSmithKline.
Study Details
Timeline
Interventions
100 mcg FF micronized drug blended with lactose per blister in one strip and 25 mcg VI micronized drug blended with lactose and magnesium stearate per blister in another strip, administered together by ELLIPTA™ inhaler
25 mcg of Vilanterol micronized drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister in one strip and lactose in another strip, administered together by ELLIPTA™ inhaler