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.
Male and female adolescent participants aged from ≥ 12 years old to less than 18 years old at screening visit
Participants with a documented diagnosis of persistent asthma (according to Global Initiative for Asthma GINA 2024) for a period of at least 1 year prior to screening.
Participants who have used medium or high dose ICS with LABA in combination (GINA 2024) for asthma for at least 3 months and at stable doses for at least 1 month prior to screening
Participants must be symptomatic / inadequately controlled according to the Investigator's opinion despite treatment with medium or high stable doses of ICS with LABA in combination (GINA 2024) before screening
Participants who have had a severe asthma attack/exacerbation requiring systemic steroids OR hospitalization (> 24 hours) OR emergency room (ER) visit (≤ 24 hours) within 6 weeks of screening. If participants experience an asthma attack/exacerbation requiring systemic steroids or emergency room visit between screening and end of run-in they may be re-screened 6 weeks after recovery from the exacerbation
Participants who have ever required intubation for a severe asthma attack/exacerbation
Participants with a history of chronic lung diseases other than asthma, including (but not limited to) sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis
Participants with Type I diabetes or uncontrolled Type II diabetes
Crossover
QVM149
DrugQVM149: Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg once daily delivered via Breezhaler®
Salmeterol Xinafoate / Fluticasone Propionate
DrugSalmeterol xinafoate 50 μg / fluticasone propionate 500 μg twice daily delivered via Girohaler®
Placebo to QVM149
DrugPlacebo to QVM149 150/50/160 µg once daily delivered via Breezhaler®
Placebo to salmeterol xinafoate / fluticasone propionate
DrugPlacebo to salmeterol xinafoate/fluticasone propionate 50/500 μg twice daily delivered via Girohaler®
Change from Baseline in Trough FEV1
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Change from Baseline in Asthma Control Questionnaire (ACQ-5) score
The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. ACQ-5 score range from 0 to 6. Higher scores indicates worsening of condition.
Change from Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) total score
Pediatric Asthma Quality of Life Questionnaire is a 23-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma, with 7-point scale (7-not bothered at all, 1-extremely bothered). It consists of 3 domains: symptoms, activity limitation and emotional function. Higher scores indicate less impairment in HRQOL. The overall PAQLQ score is the mean of all 23 responses and the individual domain scores are the means of the items in those domains.
Change from Baseline in average Rescue medication use (daily, daytime, and nighttime)
Rescue medication use over 12 weeks of each treatment period.
Number and severity of reported asthma exacerbations
Asthma exacerbations over 12 weeks of each treatment period
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