drugset / Trial / NCT05776927
A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.
RandomizedCrossoverQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of indacaterol acetate / glycopyrronium bromide / mometasone furoate (QVM149) compared to salmeterol xinafoate / fluticasone propionate in children from 12 to less than 18 years of age with asthma with pre-bronchodilator FEV1 ≥ 50 % of the predicted normal value for the participant.
Timeline
- Start
- 2026-08-04
- Primary completion
- 2028-12-30
- Completion
- 2029-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluticasone propionate | Other / unclassified | 500 ug | Inhaled |
| Subject | Glycopyrronium | Unknown | 50 ug | Inhaled |
| Subject | Indacaterol | Other / unclassified | 150 ug | Inhaled |
| Subject | Mometasone furoate | Other / unclassified | 160 ug | Inhaled |
| Subject | Salmeterol | Other / unclassified | 50 ug | Inhaled |