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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01498653 | Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry | PHASE3 | COMPLETED | 313 | — | — | Jan 1, 2012 | Feb 1, 2013 | Jan 9, 2017 | 24 | China, Philippines +1 |
Peak Expiratory Flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment.
| Arm | Type | Description |
|---|---|---|
| FF/VI 200/25mcg once daily | EXPERIMENTAL | ICS/LABA |
| Fluticasone propionate 500mcg twice daily | ACTIVE_COMPARATOR | ICS |
| Name | Type | Description |
|---|---|---|
| GW685698/GW642444 | DRUG | ICS/LABA |
| CCI18781 | DRUG | ICS |
Inclusion Criteria: 1. Informed Consent: All subjects must be able and willing to give written informed consent to take part in the study 2. Type of Subject: Outpatients, of Asian ancestry, 12 years of age or older at Visit 1 (or ≥18 years of age or older if local regulations or the regulatory stat...