Asthma
Conditions
Brief summary
Change from baseline in improving lung function (FEV1) at Week 12 of each treatment period.
Detailed description
Change from baseline in pediatric asthma symptoms (ACQ-IA), peak air flow out of the lungs (PEFR) score and the number of asthma flare ups at Week 12 of each treatment period., Measure use of rescue medication changes (daytime, night-time, and daily) over 12 weeks of each treatment period., All untoward effects happening in the study will be assessed to understand the safety of QMF149 in comparison with Budesonide based on clinical assessments, labs, ECGs and history.
Interventions
DRUGQMF149
DRUGSALBUTAMOL
DRUGFLUTICASONE PROPIONATE
DRUGThe training kit placebo is a generic Placebo hard non-gelatin capsule
DRUGinhalation. It is used to match an active dosage form in a clinical trial. The placebo comprises inactive excipients (magnesium stearate and lactose monohydrate) encapsulated in hard non-gelatin capsules matching those used for the active drug product.
DRUGMiflonide Breezhaler
DRUGinhalationspulver
DRUGhård kapsel
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in improving lung function (FEV1) at Week 12 of each treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in pediatric asthma symptoms (ACQ-IA), peak air flow out of the lungs (PEFR) score and the number of asthma flare ups at Week 12 of each treatment period., Measure use of rescue medication changes (daytime, night-time, and daily) over 12 weeks of each treatment period., All untoward effects happening in the study will be assessed to understand the safety of QMF149 in comparison with Budesonide based on clinical assessments, labs, ECGs and history. | — |
Countries
Austria, Bulgaria, Czechia, Greece, Hungary, Italy, Portugal, Romania, Spain
Outcome results
None listed