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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05562466 | A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma | PHASE3 | RECRUITING | 200 | — | — | May 11, 2023 | May 30, 2028 | Jun 5, 2026 | 62 | Argentina, Austria +14 |
| NCT03100500 | A Long-term Safety Study of QMF149 in Japanese Participants With Asthma | PHASE3 | COMPLETED | 51 | — | — | Apr 25, 2017 | Feb 12, 2019 | Feb 7, 2020 | 15 | Japan |
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.
A TEAE is any adverse event that started on or after the time of the first inhalation of study drug but not later than 7 days (30 days in the case of a SAE) after the last administration. A SAE is described as any adverse event that leads to death, is life-threatening, results in persistent or significant disability/incapacity, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event which is medically significant.
| Arm | Type | Description |
|---|---|---|
| QMF149 | EXPERIMENTAL | QMF149 75/40μg |
| Budesonide | ACTIVE_COMPARATOR | Budesonide 200μg o.d |
| Name | Type | Description |
|---|---|---|
| QMF149 | DRUG | QMF149 75/40 μg o.d via Breezhaler |
| Budesonide | DRUG | Budesonide 200 μg o.d via Breezhaler |
Inclusion Criteria 1. Male or female children ≥ 6 years and \<12 years in age at randomization. 2. Parents/legal guardian must be willing and able to attend study visits and assist the child with the procedures outlined in the protocol (e.g. compliance with taking study medication and completing th...