Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00606684 | A Study To Assess Efficacy And Safety Of Different Doses Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD) | PHASE2 | COMPLETED | 602 | — | — | Feb 1, 2008 | Oct 1, 2008 | Dec 16, 2016 | 99 | United States, Argentina +12 |
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).
| Arm | Type | Description |
|---|---|---|
| GW642444 | ACTIVE_COMPARATOR | GW642444 |
| placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| GW642444 6.25 | DRUG | GW642444 6.25 |
| GW642444 3mcg | DRUG | once daily |
| GW642444 12.5mcg | DRUG | GW642444 12.5mcg |
| GW642444 25mcg | DRUG | GW642444 25mcg |
| GW642444 50mcg | DRUG | GW642444 50mcg |
| placebo | OTHER | placebo |
Inclusion Criteria: Subjects eligible for enrollment in the study must meet all of the following criteria: * Informed Consent: Subjects who give their signed written informed consent to participate. * Gender: Male or females who are 40 - 80 years of age at Visit 1. A female is eligible to enter an...