Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-31 @ 12:19 AM
Study NCT ID:
NCT05562466
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2022-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-005591-19 | EUDRACT_NUMBER | None | View |