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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.

NCT05776927 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2026-02-03

No results posted yet for this study

Summary

A double-dummy, double-blind, randomized, parallel-group, active controlled study 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.

Conditions

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 & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-29
Primary Completion
2028-12-21
Completion
2029-12-24

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05776927 on ClinicalTrials.gov