This clinical trial is focused on studying the treatment of asthma in children aged 6 to less than 12 years. The study will compare the effectiveness and safety of a medication called QMF149, which contains two active ingredients: indacaterol acetate and mometasone furoate, against another medication known as budesonide. The purpose of the study is to determine if QMF149 is better at improving lung function in children with asthma.
Participants in the study will receive treatment over a period of 12 weeks. During this time, they will use an inhalation device called a Breezhaler to take their medication. The study will involve two treatment periods, and each child will receive both QMF149 and budesonide at different times. The study will also include a placebo, which is a capsule that looks like the medication but does not contain any active ingredients. The main goal is to see how well the medications improve lung function, measured by a test called FEV1, which checks how much air a person can exhale in one second.
In addition to lung function, the study will monitor other aspects of asthma, such as symptoms, peak air flow, and the number of asthma flare-ups. The use of rescue medication, which is taken when asthma symptoms worsen, will also be tracked. Safety assessments will be conducted throughout the study to ensure the well-being of the participants. This includes checking for any side effects through clinical assessments, laboratory tests, and heart monitoring using ECGs (electrocardiograms).
Austria 
Bulgaria 
Czechia 
Greece 
Hungary 
Italy 
Portugal 
Romania 
Spain 
