NCT05776927

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.

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.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 304 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	QVM149	QVM149: Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg od delivered via Breezhaler®
DRUG	Salmeterol Xinafoate / Fluticasone Propionate	Salmeterol Xinafoate 50 μg / Fluticasone Propionate 500 μg bid delivered via Girohaler®
DRUG	Placebo to QVM149	Placebo to QVM149: 150 μg Indacaterol Acetate / 50 μg Glycopyrronium Bromide / 160 μg Mometasone Furoate od delivered via Breezhaler®
DRUG	Placebo to Salmeterol Xinafoate / Fluticasone Propionate	Placebo to Salmeterol Xinafoate 50 μg / Fluticasone Propionate 500 μg bid delivered via Girohaler®
DRUG	Run-In Medication	Salmeterol Xinafoate 50 μg / Fluticasone Propionate 250μg bid delivered via Girohaler® or equivalent DPI device
DRUG	Rescue Medication	Salbutamol 100μg / Albuterol 90μg
DEVICE	Concept 1 Device	Concept1 (Breezhaler) used for QVM149 and placebo delivery
DEVICE	Girohaler	Girohaler for Comparator and Placebo delivery.

Timeline

• Start date: 2026-05-29
• Primary completion: 2028-12-21
• Completion: 2029-12-24
• First posted: 2023-03-20
• Last updated: 2026-02-03