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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01978119 | A Non-inferiority Study to Evaluate the Efficacy, Safety, and Tolerability of Combination Dry Powder of Fluticasone Propionate and Salmeterol (FSC) 250/50 Microgram (mcg) Twice Daily (BID) in Adults and Adolescents With Asthma | PHASE3 | COMPLETED | 124 | — | — | Nov 6, 2013 | Jan 28, 2015 | May 25, 2017 | 13 | Russia, Ukraine |
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The trough FEV1 is defined as morning prebronchodilator and predose (12 hours after the last evening dose Day 84). Trough FEV1 was measured electronically by spirometer in the morning, before using the bronchodilator and predose, at Week 12 (Day 85) of each Treatment Period. Baseline was defined as the value obtained predose (0 minutes) on day 1 in each treatment period. Change from Baseline within each period was calculated as trough FEV1 at Day 85 minus the period specific Baseline value. The change from Baseline in trough FEV1 was analysed using Mixed Model for Repeated Measures analysis, having fixed effect Participant level Baseline, Adjusted period-specific Baseline, Treatment group, Period, Visit, Visit by treatment, Visit by Participant level Baseline, Visit by Adjusted period-specific Baseline, with participant as a random effect.
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Subjects in this Arm will receive Regimen A followed by Regimen B. Regimen A: Placebo administered BID by Multi-Dose Inhaler followed by FSC (250/50 mcg) administered BID by Capsule-Based Inhaler. Regimen B: FSC (250/50 mcg) administered BID by Multi-Dose Inhaler followed by Placebo administered BID by Capsule-Based Inhaler |
| Sequence 2 | EXPERIMENTAL | Subjects in this Arm will receive Regimen B followed by Regimen A. Regimen B: FSC (250/50 mcg) administered BID by Multi-Dose Inhaler followed by Placebo administered BID by Capsule-Based Inhaler. Regimen A: Placebo administered BID by Multi-Dose Inhaler followed by FSC (250/50 mcg) administered BID by Capsule-Based Inhaler |
| Name | Type | Description |
|---|---|---|
| FSC | DRUG | Subject will be administered FSC 250 mcg/50 mcg via dry powder inhalation device or multi-dose dry powder inhalation device BID for each treatment period |
| Placebo | DRUG | Subject will be administered placebo via dry powder inhalation device or multi-dose dry powder inhalation device BID for each treatment period |
Inclusion Criteria: * Male or female \>=12 and \<=80 years of age at the time of signing the informed consent * A female subject is eligible to participate if she is of: * Non-childbearing potential defined as premenopausal females with a documented tubal ligation or hysterectomy; or postmenopausal...