Double-blind, randomized, active-controlled, two-way cross-over study, with 12-week treatment duration per period, to evaluate the efficacy and safety of QMF149 (indacaterol acetate / mometasone furoate) compared to budesonide in children from 6 to less than 12 years of age with asthma?

Double-blind, randomized, active-controlled, two-way cross-over study, with 12-week treatment duration per period, to evaluate the efficacy and safety of QMF149 (indacaterol acetate / mometasone furoate) compared to budesonide in children from 6 to less than 12 years of age with asthma

The purpose of this study is to evaluate the efficacy and safety of QMF149 (indacaterol acetate/mometasone furoate) compared to budesonide in children aged 6 to less than 12 years with mild to moderate asthma.

The primary objective of this study is to demonstrate the superiority of indacaterol (acetate)/mometasone (furoate) (QMF149) over budesonide in terms of FEV1 at week 12 of each treatment period.

Approximately 200 pediatric patients will be randomized to obtain 182 complete pediatric asthma patients.