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A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.

Asthma Clinical Trial

Official title:
A Double-dummy, Double-blind, Randomized, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Compared to Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.

Clinical Trial Summary

A double-dummy, double-blind, randomized, parallel-group, active controlled study to evaluate the efficacy and safety of QVM149 (indacaterol acetate / glycopyrronium bromide / mometasone furoate) compared to salmeterol xinafoate/fluticasone propionate in children from 12 years to less than 18 years of age with asthma.

Clinical Trial Description

This is a double-dummy, double-blind, randomized, parallel-group, 52 weeks, active controlled study to evaluate the efficacy and safety of indacaterol acetate 150 µg / glycopyrronium bromide 50 µg / mometasone furoate 160 µg (QVM149 150/50/160 µg) od in children from 12 to less than 18 years of age with asthma with pre-bronchodilator FEV1 ≥ 60 % and < 90 % of the predicted normal value for the participant. The study duration of 60 weeks includes: - a screening period of up to 15 days - a run-in period of 14 days (run-in medication: salmeterol xinafoate/fluticasone propionate 50/250 µg bid) - a treatment period of 52 weeks (either QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 µg bid, or salmeterol xinafoate/fluticasone propionate 50/500 µg bid and placebo to QVM149 150/50/160 µg od - a safety follow up period of 30 days during which the participant will be back on standard of care treatment as appropriate. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05776927
Study type Interventional
Source Novartis
Contact Novartis Pharmaceuticals
Phone +41613241111
Email novartis.email@novartis.com
Status Not yet recruiting
Phase Phase 3
Start date December 23, 2024
Completion date August 23, 2027
View Details
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