Clinical trial NCT02275052
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: shuttle walk test umeclidinium beta2-agonist exercise endurance time anticholinergic combination product vilanterol exercise COPD
Sponsor: GlaxoSmithKline
Start date: 2015-01-23; Completion date: 2016-06-02
Enrollment: 198 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a multicenter, randomized, double-blind, placebo-controlled, 2-period, complete block design cross-over study.

The purpose of this study is to evaluate the effect of UMEC/VI 62.5/25 microgram (mcg) on EET as measured by the Endurance Shuttle Walk Test (ESWT) compared to placebo. Additionally, the effect of UMEC/VI compared to placebo on lung function and lung volumes in COPD patients will be characterized.

Approximately 298 participants will be screened and, assuming 35% of these will not be eligible for randomization; approximately 194 participants will be randomized.

Eligible participants will be randomized 1:1 to one of 2 treatment sequences. In sequence 1 participants will receive UMEC/VI 62.5/25 mcg in Treatment Period 1 and placebo in Treatment Period 2. In sequence 2 participants will receive placebo in Treatment Period 1 and UMEC/VI 62.5/25 mcg in Treatment Period 2. Treatments will be delivered once-daily via a dry powder inhaler (DPI). Each treatment period will be for 12 weeks and will be separated by a wash out period of 12-17 days. The total duration of patient participation, including the Follow-Up will be approximately 30 weeks. All participants will be provided with albuterol for use on an "as needed (prn)" basis throughout the run-in, washout and study treatment periods while on investigational product.

Detailed description:

Arms: arm 1: Participants will self-administer blinded UMEC/VI (62.5 mcg/25 mcg) each morning (once daily) as one inhalation from the double-blind DPI in one of the 2 treatment periods of 12 weeks. The treatment periods will be separated by a wash out period of 12-17 days. arm 2: Participants will self-administer blinded placebo each morning (once daily) as one inhalation from the double-blind DPI in one of the 2 treatment periods of 12 weeks. The treatment periods will be separated by a wash out period of 12-17 days
Interventions: intervention 1: UMEC/VI DPI intervention 2: Placebo DPI intervention 3: Albuterol/salbutamol MDI
Intervention descriptions: intervention 1: The DPI will contain a total of 30 doses. Each DPI will be comprised of two double-foil, laminate blister strips. Each blister of one strip will consist of 62.5mcg of UMEC blended with lactose and magnesium stearate while each blister of other strip will consist of 25 mcg of VI blended with lactose and magnesium stearate. Each actuation of the DPI will deliver the contents of one blister from each strip simultaneously intervention 2: The placebo DPI, identical in appearance to the inhaler containing active study medication, will have two blister strips, each containing 30 blisters of lactose and magnesium stearate. intervention 3: Albuterol/salbutamol MDI (metered-dose inhaler) or nebules will be permitted throughout the study as rescue medication, for use as-needed. Albuterol/salbutamol will be sourced from local commercial stock or provided centrally from GlaxoSmithKline. Nebules will not be supplied.

Protocol documents: