NCT05562466

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	QMF149	QMF149 75/40 μg o.d via Breezhaler
DRUG	Budesonide	Budesonide 200 μg o.d via Breezhaler

Timeline

• Start date: 2023-05-11
• Primary completion: 2028-02-01
• Completion: 2028-05-30
• First posted: 2022-09-30
• Last updated: 2026-04-06

Locations

62 sites across 16 countries: Argentina, Austria, Bulgaria, Colombia, Czechia, Greece, Guatemala, Hungary, Italy, Mexico, Panama, Portugal, Romania, South Africa, Spain, Vietnam