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.

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

304

Participants

Timeline

Start Date

February 1, 2026

Primary Completion Date

March 18, 2026

Study Completion Date

February 1, 2029

Conditions
Asthma
Interventions
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.

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY