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RECRUITING
NCT05776927
PHASE3

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

View on ClinicalTrials.gov

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

DRUG

QVM149

QVM149: Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg once daily delivered via Breezhaler®

DRUG

Salmeterol Xinafoate / Fluticasone Propionate

Salmeterol xinafoate 50 μg / fluticasone propionate 500 μg twice daily delivered via Girohaler®

DRUG

Placebo to QVM149

Placebo to QVM149 150/50/160 µg once daily delivered via Breezhaler®

DRUG

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