Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: SGRQ vilanterol long-acting beta2-agonist long-acting muscarinic antagonist COPD umeclidinium
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 498
Healthy volunteers: no

Brief summary:
This study is a 12-week, multicenter, randomized, double blind, parallel group, placebo-controlled study.

The purpose of this study is to replicate the therapeutic benefit of UMEC/VI 62.5/25 microgram (mcg) on health-related quality of life as reflected by St. George's Respiratory Questionnaire (SGRQ) scores and symptoms as reflected by rescue medication use observed in the 6 month placebo controlled study (DB2113373). Lung function will be assessed as it provides an objective measure to support the subjective patient reported outcomes of SGRQ and rescue medication use. The study is intended to provide additional evidence to support the use of UMEC/VI for the maintenance treatment of COPD Approximately 496 subjects will be randomized from approximately 62 centers in order to ensure 422 subjects complete 12 weeks of treatment. Eligible subjects will be randomized to UMEC/VI 62.5/25mcg or placebo in a 1:1 ratio. All treatments will be administered once-daily in the morning via a Dry Powder Inhaler (DPI).

There will be a total of 5 clinic visits. The total duration of study participation will be approximately 15 weeks. All subjects will be provided with albuterol/salbutamol to use as needed for the relief of COPD symptoms throughout the run-in and double-blind treatment periods.

Detailed description:

Arms:
arm 1: The subjects will receive UMEC/VI 62.5/25 mcg, administered as one inhalation once-daily in the morning via a dry powder inhaler (DPI) arm 2: The subjects will receive placebo, administered as one inhalation once-daily in the morning via a DPI

Interventions: intervention 1: UMEC/VI intervention 2: Placebo
Intervention descriptions: intervention 1: Dry white powder delivered via DPI (2 strips with 30 blisters each, first containing UMEC 62.5 mcg per blister and second containing VI 25 mcg per blister), administered as one inhalation of UMEC/VI 62.5/25 mcg intervention 2: Dry white powder delivered via DPI (2 strips with 30 blisters each, both containing lactose with magnesium stearate), administered as one inhalation of placebo

Protocol document: