Comparing QVM149 and Salmeterol XinafoateFluticasone Propionate for Asthma Treatment in Children Aged 12 to Under 18

What this Trial Is About

Researchers are evaluating the efficacy and safety of the triple combination drug QVM149 indacaterol acetate, glycopyrronium bromide, and mometasone furoate compared to the combination of salmeterol xinafoate and fluticasone propionate in children aged 12 to less than 18 years with asthma. The study focuses on participants who have a pre-bronchodilator FEV1 of at least 50% of the predicted normal value. This phase 3, double-blind, randomized, crossover study aims to assess improvements in lung function and asthma control. Participants first undergo a screening period up to 15 days, followed by a 14-day run-in period using salmeterol xinafoate with fluticasone propionate delivered by an inhaler. Then, they enter two 12-week treatment periods where they receive either QVM149 once daily with a placebo or salmeterol xinafoatefluticasone propionate twice daily with a placebo, separated by a 3-week washout using a lower dose of salmeterol xinafoatefluticasone propionate. After completing both treatments, a 30-day safety follow-up period occurs where participants return to their standard care. Throughout the study, participants use rescue medication as needed and undergo assessments including lung function measurements, asthma control questionnaires, quality of life evaluations, and tracking of rescue medication use. Researchers monitor the number and severity of asthma exacerbations and record any adverse events from the first dose until 30 days after the last dose. The total study duration is approximately 36 weeks, allowing detailed evaluation of the treatments impact and safety in this pediatric population.

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.