A double-dummy, double-blind, randomized, active controlled, two-way cross-over study with 12-week treatment duration per 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.
Poland, France, Slovakia, Spain, Hungary, Germany, Romania
Condition studied
Asthma
Investigational medicinal product(s)
AirFluSal Forspiro 50 microgram/500 microgram per actuation inhalation powderpre-dispensedSeretide Accuhaler 50 microgram/250 microgram/ dose inhalation powderpredispensed.Ventolin Evohaler 100 micrograms Pressurised Inhalation SuspensionPlacebo for Salmeterol xinafoate/ fluticasone propionateQVM149Placebo to QVM149
Eligibility
Age group
0-17 years
Sex
Female, Male
Primary endpoint
● Change from baseline in trough FEV1 at Week 12 of each treatment period.
Endpoint detail
● Change from baseline in (ACQ-5) score at Week 12 of each treatment period ● Change from baseline in (PAQLQ) total score at Week 12 of each treatment period ● Change from baseline in average rescue medication use (daily, daytime, and night-time) over 12 weeks of each treatment period ● Number and severity of reported asthma exacerbations over 12 weeks of each treatment period, Safety assessments including incidence of adverse events, serum cortisol, blood glucose, serum potassium, electrocardiography, local side effects of ICS
Official registry record
This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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