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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01181895 | Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma | PHASE3 | COMPLETED | 348 | — | — | Sep 1, 2010 | Aug 26, 2011 | Nov 8, 2017 | 34 | United States, Germany +3 |
FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, at Week 12. The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline is calculated as the weighted mean 0-24 hour FEV1 (Liters) at Week 12 minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment.
| Arm | Type | Description |
|---|---|---|
| Vilanterol | EXPERIMENTAL | Vilanterol inhalation powder once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks |
| Salmeterol | ACTIVE_COMPARATOR | Placebo inhalation powder via NDPI once daily + Salmeterol inhalation powder twice daily for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo inhalation powder via NDPI once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Vilanterol | DRUG | Vilanterol inhalation powder inhaled orally once daily for 12 weeks |
| Salmeterol Inhalation Powder | DRUG | Salmeterol inhalation powder inhaled orally twice daily for 12 weeks |
| Placebo Inhalation Powder NDPI | DRUG | Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler |
| Placebo Inhalation Powder Diskus | DRUG | Placebo inhalation powder inhaled orally twice daily for 12 weeks |
Inclusion Criteria: * Outpatient at least 12 years of age * Both genders; females of childbearing potential must be willing to use birth control method * Clinical diagnosis of asthma for ≥12 weeks * Best pre-bronchodilator FEV1 of 40%-90% predicted * Reversibility of FEV1 of at least 12% and 200mls...