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.
RandomizedParallel-groupQuadruple-blindTreatment
Summary
A double-dummy, double-blind, randomized, parallel-group, active controlled study to evaluate the efficacy and safety of QVM149 (indacaterol acetate / glycopyrronium bromide / mometasone furoate) compared to salmeterol xinafoate/fluticasone propionate in children from 12 years to less than 18 years of age with asthma.
Timeline
- Start
- 2026-05-29
- Primary completion
- 2028-12-21
- Completion
- 2029-12-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Fluticasone | Other / unclassified | 500 ug | Inhaled |
| Subject | Glycopyrronium | Unknown | 50 ug | Inhaled |
| Subject | Indacaterol | Other / unclassified | 150 ug | Inhaled |
| Subject | Mometasone | Other / unclassified | 160 ug | Inhaled |
| Background | Salmeterol | Other / unclassified | 50 ug | Inhaled |
| Background | Fluticasone | Other / unclassified | 250 ug | Inhaled |
| Background | Salbutamol | Unknown | 90 ug | — |
| Background | Salbutamol | Unknown | 100 ug | — |
| Background | Salmeterol | Other / unclassified | 50 ug | Inhaled |