This is a double-dummy, double-blind, randomized, parallel-group, 52 weeks, active controlled study to evaluate the efficacy and safety of indacaterol acetate 150 µg / glycopyrronium bromide 50 µg / mometasone furoate 160 µg (QVM149 150/50/160 µg) od in children from 12 to less than 18 years of age with asthma with pre-bronchodilator FEV1 ≥ 60 % and < 90 % of the predicted normal value for the participant.~The study duration of 60 weeks includes:~a screening period of up to 15 days~a run-in period of 14 days (run-in medication: salmeterol xinafoate/fluticasone propionate 50/250 µg bid)~a treatment period of 52 weeks (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~a safety follow up period of 30 days during which the participant will be back on standard of care treatment as appropriate.
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.