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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02892344 | Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma | PHASE3 | COMPLETED | 802 | — | — | Jan 16, 2017 | Nov 30, 2018 | Jan 13, 2026 | 123 | Bulgaria, Chile +20 |
demonstrate the superiority of QMF149 150/80 microgram o.d. (in the evening) delivered via Concept1 compared with MF 200 microgram o.d. (in the evening) delivered via Twisthaler® in terms of trough FEV1 after 12 weeks of treatment in adults and adolescents. Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured by spirometry.
| Arm | Type | Description |
|---|---|---|
| QMF149 150/80 μg | EXPERIMENTAL | QMF149 150/80 microgram o.d. delivered via Concept1 |
| MF 200 µg | ACTIVE_COMPARATOR | MF 200 microgram o.d. delivered via Twisthaler® |
| Name | Type | Description |
|---|---|---|
| QMF149 150/80 μg | DRUG | QMF149 150/80 μg o.d via Concept1 |
| MF 200 μg | DRUG | MF 200 μg o.d. via Twisthaler® |
Inclusion Criteria: * Patients with a documented diagnosis of asthma for a period of at least 3 months prior to Screening Visit * Patients who have used low dose ICS , with or without controller (ie, LABA, Leukotriene Receptor Antagonist ) at stable dose for at least 1 month prior to Screening Visi...