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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
188
QVM149: Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg once daily delivered via Breezhaler®
Salmeterol xinafoate 50 μg / fluticasone propionate 500 μg twice daily delivered via Girohaler®
Placebo to QVM149 150/50/160 µg once daily delivered via Breezhaler®
Placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg twice daily delivered via Girohaler®
Novartis Investigative Site
Strasbourg, France
RECRUITINGNovartis Investigative Site
Szeged, Hungary
RECRUITINGNovartis Investigative Site
Tarnów, Poland, Poland
RECRUITINGNovartis Investigative Site
Bialystok, Poland
RECRUITINGNovartis Investigative Site
Krakow, Poland
RECRUITINGNovartis Investigative Site
Lublin, Poland
RECRUITINGNovartis Investigative Site
Piaseczno, Poland
RECRUITINGNovartis Investigative Site
Torun, Poland
RECRUITINGNovartis Investigative Site
Bucharest, Romania
RECRUITINGNovartis Investigative Site
Bratislava, Mestska Cast Ruzinov, Slovakia
RECRUITING...and 9 more locations
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.
Time frame: Baseline, Week 12 of each treatment period.
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.
Time frame: Baseline, Week 12 of each treatment period
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.
Time frame: Baseline, Week 12 of each treatment period
Change from Baseline in average Rescue medication use (daily, daytime, and nighttime)
Rescue medication use over 12 weeks of each treatment period.
Time frame: Baseline, Week 12 of each treatment period
Number and severity of reported asthma exacerbations
Asthma exacerbations over 12 weeks of each treatment period
Time frame: Baseline, Week 12 of each treatment period
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Time frame: From first dose up to 30 days after last dose (up to 31 weeks)
Novartis Pharmaceuticals
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