304
Participants
Start Date
February 1, 2026
Primary Completion Date
March 18, 2026
Study Completion Date
February 1, 2029
QVM149
QVM149: Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg od delivered via Breezhaler®
Salmeterol Xinafoate / Fluticasone Propionate
Salmeterol Xinafoate 50 μg / Fluticasone Propionate 500 μg bid delivered via Girohaler®
Placebo to QVM149
Placebo to QVM149: 150 μg Indacaterol Acetate / 50 μg Glycopyrronium Bromide / 160 μg Mometasone Furoate od delivered via Breezhaler®
Placebo to Salmeterol Xinafoate / Fluticasone Propionate
Placebo to Salmeterol Xinafoate 50 μg / Fluticasone Propionate 500 μg bid delivered via Girohaler®
Run-In Medication
Salmeterol Xinafoate 50 μg / Fluticasone Propionate 250μg bid delivered via Girohaler® or equivalent DPI device
Rescue Medication
Salbutamol 100μg / Albuterol 90μg
Concept 1 Device
Concept1 (Breezhaler) used for QVM149 and placebo delivery
Girohaler
Girohaler for Comparator and Placebo delivery.
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY