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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01323621 | Study Evaluating the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD) | PHASE3 | COMPLETED | 512 | — | — | Mar 18, 2011 | Jan 24, 2012 | Feb 15, 2018 | 51 | United States, Germany +4 |
| NCT01323634 | Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease | PHASE3 | COMPLETED | 519 | — | — | Mar 18, 2011 | Dec 14, 2011 | Nov 8, 2017 | 50 | United States, Czechia +4 |
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours post-dose on Treatment Day 84. Baseline trough FEV1 was calculated as the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value. Analysis of covariance (ANCOVA) was conducted with covariates for country, smoking status, reversibility, and Baseline FEV1.
Pulmonary function was measured by forced expiratory volume in one second (FEV1). The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value.
| Arm | Type | Description |
|---|---|---|
| Fluticasone Furoate / GW642444 (vilanterol) | EXPERIMENTAL | Inhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA) |
| Fluticasone Propionate / salmeterol | ACTIVE_COMPARATOR | Inhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA) |
| Name | Type | Description |
|---|---|---|
| Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg | DRUG | inhalation powder |
| Fluticasone Propionate 250mcg / salmeterol 50mcg | DRUG | inhalation powder |
| Double-dummy placebo | DRUG | inhalation powder |
| Salbutamol as needed | DRUG | inhalation powder |
| Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcg | DRUG | inhalation powder |
| Fluticasone Propionate 250mcg/ salmeterol 50mcg | DRUG | inhalation powder |
Inclusion Criteria: * Signed and dated written informed consent * Male or females ≥ 40 years of age * Established clinical history of COPD by ATS/ERS definition * Females are eligible to enter and participate if of non-childbearing potential, or if of child bearing potential, has a negative serum p...