Available in Argentina
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.
200Patients around the world