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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.
Sponsor: Novartis Pharmaceuticals
Summary
The purpose of this study is to evaluate the efficacy and safety of indacaterol acetate / glycopyrronium bromide / mometasone furoate (QVM149) compared to salmeterol xinafoate / fluticasone propionate in children from 12 to less than 18 years of age with asthma with pre-bronchodilator FEV1 ≥ 50 % of the predicted normal value for the participant.
Official title: A Double-dummy, Double-blind, Randomized, Active Controlled, Two-way Cross-over Study With 12 Week Treatment Duration Period, 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.
Key Details
Gender
All
Age Range
12 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
188
Start Date
2026-08-04
Completion Date
2029-01-30
Last Updated
2026-09-28
Healthy Volunteers
No
Conditions
Interventions
QVM149
QVM149: Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg once daily delivered via Breezhaler®
Salmeterol Xinafoate / Fluticasone Propionate
Salmeterol xinafoate 50 μg / fluticasone propionate 500 μg twice daily delivered via Girohaler®
Placebo to QVM149
Placebo to QVM149 150/50/160 µg once daily delivered via Breezhaler®
Placebo to salmeterol xinafoate / fluticasone propionate
Placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg twice daily delivered via Girohaler®
Locations (21)
Novartis Investigative Site
Strasbourg, France
Novartis Investigative Site
Szeged, Hungary
Novartis Investigative Site
Tarnów, Poland, Poland
Novartis Investigative Site
Bialystok, Poland
Novartis Investigative Site
Krakow, Poland
Novartis Investigative Site
Lublin, Poland
Novartis Investigative Site
Piaseczno, Poland
Novartis Investigative Site
Torun, Poland
Novartis Investigative Site
Bucharest, Romania
Novartis Investigative Site
Bratislava, Mestska Cast Ruzinov, Slovakia
Novartis Investigative Site
Košice, Slovakia
Novartis Investigative Site
East London, Eastern Cape, South Africa
Novartis Investigative Site
Germiston, Gauteng, South Africa
Novartis Investigative Site
Krugersdorp, Gauteng, South Africa
Novartis Investigative Site
Lenasia, Gauteng, South Africa
Novartis Investigative Site
Paarl, Western Cape, South Africa
Novartis Investigative Site
Cape Town, South Africa
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain
Novartis Investigative Site
Sabadell, Barcelona, Spain
Novartis Investigative Site
Seville, Spain
Novartis Investigative Site
Kaohsiung City, Taiwan