Who is sponsoring NCT02119286?

NCT02119286 is sponsored by GlaxoSmithKline.

What condition does NCT02119286 study?

NCT02119286 studies Pulmonary Disease, Chronic Obstructive.

What drugs are being tested in NCT02119286?

Interventions: FF, VI, UMEC, Placebo.

What is the status of NCT02119286?

NCT02119286 is currently COMPLETED.

Last reviewed 2017-03-21 · How we verify

A Study to Compare the Addition of Umeclidinium Bromide (UMEC) to Fluticasone Furoate (FF)/Vilanterol (VI), With Placebo Plus FF/VI in Subjects With Chronic Obstructive Pulmonary Disease (COPD) -Study 2

NCT02119286 Phase 3 COMPLETED Results posted

After screening, subjects will enter a 4 week open-label run-in period with fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler (DPI). Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium bromide \[UMEC\] \[62.5 mcg\] administered once daily via a DPI; OR UMEC \[125 mcg\] administered once daily via a DPI; OR matching placebo administered once daily via a DPI), while continuing treatment with open label FF/VI 100/25 mcg during a 12-week treatment period. There will be a total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening (Visit 1), blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6) and 85 (Visit7). A follow-up phone contact will be conducted approximately 7 days after the last clinic visit. The total duration of subject participation in the study from Screening to Follow-up will be approximately 17 weeks.

Details

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	COMPLETED
Enrolment	620
Start date	2013-10
Completion	2014-04

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

FF
VI
UMEC
Placebo

Primary outcomes

Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85 — Day 85
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84. Analysis was performed using a mixed model repeated measures (MMRM) with covariates of treatment, Baseline FEV1, smoking status, Day, treatment, Day by baseline interaction and Day by treatment interaction, Day being nominal. Baseline FEV1 is the mean of the two assessments made at 30 and 5 minutes (min) pre-dose on Day 1. The change from baseline value is the difference between the on-treatment value and the baseline value.

Countries

United States, Czechia, Germany, South Korea