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.
brief 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.
detailed description
This is a double-dummy, double-blind, randomized, active controlled, two-way two-period treatment (12 weeks duration each) cross-over study.
The study duration of 36 weeks includes:
* a screening period of up to 15 days (rescue medication: short acting β2-agonist (SABA) salbutamol 100 μg or albuterol 90 μg via a Metered-Dose Inhaler (MDI) to use as-needed throughout the study). * a run-in period of 14 days (run-in medication: salmeterol xinafoate 50 μg / fluticasone propionate 250μg bid delivered via Girohaler® or equivalent DPI device) * two treatment period of 12 weeks each (either QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 µg bid, or salmeterol xinafoate/fluticasone propionate 50/500 µg bid and placebo to QVM149 150/50/160 µg od, separated by a 3 week washout period (wash-out medication: salmeterol xinafoate/fluticasone propionate 50/250 µg bid) * a safety follow up period of 30 days during which the participant will be back on standard of care treatment as appropriate.
official title
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.