Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
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

2026-08-26

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 (4)

Novartis Investigative Site

Tarnów, Poland, Poland

Novartis Investigative Site

Germiston, Gauteng, South Africa

Novartis Investigative Site

Krugersdorp, Gauteng, South Africa

Novartis Investigative Site

Lenasia, Gauteng, South Africa