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NCT05776927 · ClinicalTrials.gov record · last posted 2026-08-26

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.

StatusRecruiting
PhasePhase 3
Started2026-08-04
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from the ClinicalTrials.gov record
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.

Protocol amendment history 4 changes detected by DataLookout

2026-08-13
Recruitment opened
2026-07-28
Primary endpoint(s) modified
WasChange from Baseline in Trough FEV1 at Week 26.
NowChange from Baseline in Trough FEV1
2026-07-28
Enrollment reduced: 304 → 188 participants
2026-07-28
Completion moved earlier: 2029-12-24 → 2029-01-30
Trial Details
NCT Number NCT05776927
Lead Sponsor Novartis Pharmaceuticals
Conditions Asthma
Enrollment 188 participants
Start Date 2026-08-04
Primary Completion 2028-12-30 (estimated)
Study Completion 2029-01-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-26