A double-dummy, double-blind, randomized, active controlled, two-way cross-over study with 12-week treatment duration per 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.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502365-26-00

Enrollment

Registered

2026-06-01

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

● Change from baseline in trough FEV1 at Week 12 of each treatment period.

Detailed description

● Change from baseline in (ACQ-5) score at Week 12 of each treatment period ● Change from baseline in (PAQLQ) total score at Week 12 of each treatment period ● Change from baseline in average rescue medication use (daily, daytime, and night-time) over 12 weeks of each treatment period ● Number and severity of reported asthma exacerbations over 12 weeks of each treatment period, Safety assessments including incidence of adverse events, serum cortisol, blood glucose, serum potassium, electrocardiography, local side effects of ICS

Interventions

DRUGQVM149

DRUGPlacebo to QVM149

DRUGAirFluSal Forspiro 50 microgram/500 microgram per actuation inhalation powder

DRUGpre-dispensed

DRUGPlacebo for Salmeterol xinafoate/ fluticasone propionate

DRUGSeretide Accuhaler 50 microgram/250 microgram/ dose inhalation powder

DRUGpredispensed.

DRUGVentolin Evohaler 100 micrograms Pressurised Inhalation Suspension

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
● Change from baseline in trough FEV1 at Week 12 of each treatment period.	—

Secondary

Measure	Time frame
● Change from baseline in (ACQ-5) score at Week 12 of each treatment period ● Change from baseline in (PAQLQ) total score at Week 12 of each treatment period ● Change from baseline in average rescue medication use (daily, daytime, and night-time) over 12 weeks of each treatment period ● Number and severity of reported asthma exacerbations over 12 weeks of each treatment period, Safety assessments including incidence of adverse events, serum cortisol, blood glucose, serum potassium, electrocardiography, local side effects of ICS	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 3, 2026