Phase 3Recruiting
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.
A Double-dummy, Double-blind, Randomized, Active Controlled, Two-way Cross-over Study With 12 Week Treatment Duration Period, 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.
- Sponsor
- Novartis Pharmaceuticals (Industry)
- Enrollment
- 188 planned
- Conditions
- Asthma
- Interventions
- QVM149; Salmeterol Xinafoate / Fluticasone Propionate; Placebo to QVM149; Placebo to salmeterol xinafoate / fluticasone propionate
- Ages
- children
- Registry
- NCT05776927, CTIS2022-502365-26-00
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change from Baseline in Trough FEV1
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered