The purpose of this study is to evaluate the superiority in terms of efficacy and evaluate the safety of QMF149 (indacaterol (acetate) / mometasone (furoate)) compared to budesonide in children from 6 to less than 12 years of age with asthma.
* The study duration will be up to 37 weeks including an investigational treatment duration of 12 weeks and a comparator treatment duration of 12 weeks. * The visit frequency will be 3 weeks for screening, run-in and wash-out period, 6 weeks interval for visits during each treatment period, 30 days for safety follow-up.
Male or female children ≥ 6 years and <12 years in age at randomization.
Parents/legal guardian must be willing and able to attend study visits and assist the child with the procedures outlined in the protocol (e.g. compliance with taking study medication and completing the diary) ((≥ 70% during the last 14 days of the Run-in period)).
Confirmed/documented diagnosis of asthma, as defined by national or international asthma guidelines for at least 12 months prior to study enrollment.
Written and signed informed consent by parent(s)/legal guardian(s) for the pediatric patient and assent by the pediatric patient (depending on local requirements) must be obtained before any study-specific assessment is performed.
Prior intubation for asthma.
Patients who have had a severe asthma exacerbation requiring in the previous month either systemic steroids or hospitalization due to asthma (>24h) or emergency room visit (≤24 hours).
Subjects receiving any medications in the classes specified in Table 6 6 unless they undergo the required washout period prior to Treatment Visit (Day 1) and follow the adjustment through the treatment period.
Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
Crossover
QMF149
DrugQMF149 75/40 μg o.d via Breezhaler
Budesonide
DrugBudesonide 200 μg o.d via Breezhaler
Change from baseline in trough FEV1
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured by spirometry.
Change from baseline in ACQ-IA score
The Asthma Control Questionnaire-Interview Administered (ACQ-IA) includes seven questions that assess nighttime awakenings, waking in the morning with symptoms, limitation of daily activities, shortness of breath, wheezing, forced expiratory volume in the first second (FEV1% predicted), and daily rescue bronchodilator use.
Change from baseline in average Morning and Evening PEFR
Morning and Evening Peak Expiratory Flow Rate (PEF) will be measured. PEF is the peak expiratory flow, the maximum speed of expiration.
Change from baseline in average rescue medication use
Change from baseline in average rescue medication use (daytime, night-time, and daily) over 12 weeks of each treatment period
Annual rate of asthma exacerbations
Annual rate of asthma exacerbations by exacerbation category (any, moderate or severe, severe)
Click on the lead sponsor to view all of their trials.