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Study B2C111045, A Dose-Finding Study of GW642444 Versus Placebo in Patients With COPD
This study will assess the safety and efficacy of 5 doses GW642444 in subjects with Chonic Obstructive Pulmonary Disease (COPD)
Details
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 602 |
| Start date | 2008-02 |
| Completion | 2008-10 |
Conditions
- Pulmonary Disease, Chronic Obstructive
Interventions
- GW642444 6.25
- GW642444 3mcg
- GW642444 12.5mcg
- GW642444 25mcg
- GW642444 50mcg
- placebo
Primary outcomes
- Mean Change From Baseline in Trough (Pre Bronchodilator and Pre Dose) FEV1 on Day 29 — Baseline (BL) and Day 29
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then Baseline is defined as the single pre-dose FEV1 value at Day 1. The trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24-hours after dosing on Day 28 and the Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Change from Baseline in trough FEV1 was calculated as the value on Day 29 minus the value at Baseline. Analysis was performed using Analysis of Covariance (ANCOVA) using Last Observation Carried Forward (LOCF) with covariates of baseline, sex, age, smoking status (at screening), reversibility stratum, and treatment (trt).
Countries
United States, Argentina, Canada, Chile, Denmark, Estonia, Germany, Mexico, Peru, Philippines, Poland, Russia, Slovakia, South Korea