A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma
- Registration Number
- NCT05562466
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
This is a double-blind, randomized, active controlled, 2 period, 2 treatment (12 weeks duration each) cross-over multi-center study to evaluate the efficacy and safety of indacaterol (acetate)/ mometasone (furoate) compared to budesonide in terms of superiority in children from 6 to less than 12 years of age with asthma with FEV1 ≥50% of the predicted normal value for the participant.
The study duration of 37 weeks includes:
* a screening period of up to 3 weeks
* a run-in period of 3 weeks (run-in medication: Fluticasone propionate 50μg bid)
* a first treatment period of 12 weeks (either with QMF149 75/40μg o.d or budesonide 200 μg o.d via Breezhaler)
* a wash out period of 3 weeks (wash-out medication: Fluticasone propionate 50μg bid)
* a second treatment period of 12 weeks (cross over of the 2 treatment groups with either QMF149 75/40μg o.d or budesonide 200 μg o.d via Breezhaler)
* a safety follow-up period of 4 weeks during which the patient will be back on standard of care treatment as appropriate At the completion of the follow-up period, patient's safety information as well as survival status will be collected.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description QMF149 QMF149 QMF149 75/40μg Budesonide Budesonide Budesonide 200μg o.d
- Primary Outcome Measures
Name Time Method Change from baseline in trough FEV1 Week 12 of each treatment period 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.
- Secondary Outcome Measures
Name Time Method Annual rate of asthma exacerbations Over 12 weeks with each treatment Annual rate of asthma exacerbations by exacerbation category (any, moderate or severe, severe)
Change from baseline in ACQ-IA score At week 12 of each treatment period 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 rescue medication use Over 12 weeks of each treatment period Change from baseline in average rescue medication use (daytime, night-time, and daily) over 12 weeks of each treatment period
Change from baseline in average Morning and Evening PEFR Over 12 weeks of each treatment period Morning and Evening Peak Expiratory Flow Rate (PEF) will be measured. PEF is the peak expiratory flow, the maximum speed of expiration.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) From informed consent until 30 days after last dose of study treatment Incidence of AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇪🇸Madrid, Spain