Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD Fluticasone Furoate (FF) Vilanterol (VI) Dry Powder Inhaler
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1621
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) arm 2: Long-acting beta2-agonist (LABA)

Interventions: intervention 1: Fluticasone Furoate/Vilanterol intervention 2: Vilanterol
Intervention descriptions: intervention 1: 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 intervention 2: 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

Protocol document: