What is QMF149 studying for asthma in children?

QMF149 is being studied to see if it works better than budesonide and to evaluate its safety in children aged 6 to less than 12 years with asthma. Researchers want to understand if this combination medication can improve lung function and asthma control compared to current treatments. The study is sponsored by Novartis Pharmaceuticals.

Who may be eligible for this asthma clinical trial?

Children aged 6 to 11 with a confirmed asthma diagnosis for at least 12 months may be eligible. Participants must be symptomatic and using stable low dose inhaled corticosteroids, with or without one additional controller medication. Both boys and girls can join. Please review eligibility criteria for more details.

Is there any cost to participate in this asthma clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses to attend visits may vary and are not guaranteed to be covered. Participants and families should plan accordingly.

Actively Recruiting

Phase 3

Age: 6Years - 11Years

All Genders

ID05562466

Study Comparing the Safety and Effectiveness of QMF149 Versus Budesonide in Children Ages 6 to Under 12 with Asthma

Led by Novartis Pharmaceuticals · Updated on 2026-07-13

200

Participants Needed

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying children aged 6 to less than 12 years with asthma to compare the effects and safety of QMF149 a combination of indacaterol acetate and mometasone furoate with budesonide. This Phase 3, double-blind, randomized, two-period, crossover study aims to determine if QMF149 is superior to budesonide in improving lung function and asthma control in this pediatric population. Participants undergo a total study duration of up to 37 weeks, including screening and run-in periods, two 12-week treatment phases where they receive either QMF149 7540 mcg once daily or budesonide 200 mcg once daily via Breezhaler, separated by a 3-week washout period with fluticasone propionate. Following treatment periods, a 4-week safety follow-up occurs during which patients return to standard care. Throughout the study, children and their parentslegal guardians attend scheduled visits for assessments including lung function tests FEV1, asthma control questionnaires, peak expiratory flow rate measurements, and rescue medication use tracking. Safety is monitored by recording adverse events up to 30 days after the last dose. The study evaluates changes from baseline in lung function and asthma control after each treatment period, with participants supported in completing diaries and attending visits over the 37-week timeline.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 6Years - 11Years

All Genders

Eligibility Criteria

You may qualify if you...

Male or female children aged 6 to less than 12 years at randomization
Parent or legal guardian willing and able to attend visits and assist with study procedures
Confirmed asthma diagnosis for at least 12 months before enrollment
Written informed consent from parent/legal guardian and assent from child as required
Receiving stable low dose inhaled corticosteroids (up to 100 mcg fluticasone propionate daily) alone or with one additional controller for at least 3 weeks before randomization
Symptomatic at randomization with ACQ-IA score ≥1.5
Pre-bronchodilator FEV1 ≥50% of predicted normal at start and end of run-in
Demonstrated acceptable inhaler technique and ability to complete spirometry
Parent/legal guardian able to complete e-Diary entries and attend visits
Negative COVID-19 test within 3 days prior to randomization
For optional pharmacokinetics analysis, weighing at least 25 kg at screening

You will not qualify if you...

Prior intubation for asthma
Severe asthma exacerbation requiring systemic steroids, hospitalization, or emergency visit within 1 month before screening
Use of prohibited medications without required washout before treatment
Use of other investigational drugs within 5 half-lives or 30 days prior to enrollment
History of malignancy within past 5 years except certain skin or cervical cancers
Impaired renal function or related urinary abnormalities
Respiratory tract infection within 4 weeks before screening or between screening and run-in
Chronic respiratory conditions other than asthma
Clinically significant oropharyngeal candidiasis at or before run-in
History of chronic lung diseases such as sarcoidosis, cystic fibrosis, COPD, or asthma/COPD overlap
Long QT syndrome or prolonged QTc interval at run-in
Clinically significant ECG or laboratory abnormalities before run-in
Medical or surgical conditions affecting drug metabolism or study safety
Inability to comply with study procedures
Immediate family member of study personnel
Theophylline use within specified prior periods
Use of non-approved experimental asthma drugs within 4 weeks prior to screening
Use of long-acting muscarinic antagonists within 3 months prior to screening
Unstable disease within 4 weeks prior to screening
Hypersensitivity to study drugs or related compounds
Type I diabetes or uncontrolled Type II diabetes prior to run-in
Use of prohibited asthma or non-asthma medications
Recent allergy immunotherapy or desensitization
Female participants of childbearing potential not agreeing to contraception or abstinence

Research Team

Novartis Pharmaceuticals

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Study Comparing the Safety and Effectiveness of QMF149 Versus Budesonide in Children Ages 6 to Under 12 with Asthma

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria