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
Study ID
NCT05776927
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • QVM149 — DRUG
    QVM149: Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg once daily delivered via Breezhaler®
  • Salmeterol Xinafoate / Fluticasone Propionate — DRUG
    Salmeterol xinafoate 50 μg / fluticasone propionate 500 μg twice daily delivered via Girohaler®
  • Placebo to QVM149 — DRUG
    Placebo to QVM149 150/50/160 µg once daily delivered via Breezhaler®
  • Placebo to salmeterol xinafoate / fluticasone propionate — DRUG
    Placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg twice daily delivered via Girohaler®

Study Details

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.

Key Dates

First listed
Mar 20, 2023
Start date
Aug 4, 2026
Status verified
Aug 2026
Primary completion
Dec 30, 2028
Completion
Jan 30, 2029

Study Design

Enrollment
188 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: QVM149 first, then salmeterol xinafoate/fluticasone propionate
    * QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg bid during treatment period 1. * Then, after a 3-week washout period, salmeterol xinafoate/fluticasone propionate 50/500 μg bid and placebo to QVM149 150/50/160 µg od during treatment period 2.
  • Experimental: Arm 2: Salmeterol xinafoate/fluticasone propionate first, then QVM149
    * Salmeterol xinafoate/fluticasone propionate 50/500 μg bid and placebo to QVM149 150/50/160 µg od during treatment period 1. * Then, after a 3-week washout period, QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg bid during treatment period 2.

Primary Outcome Measure

Change from Baseline in Trough FEV1 [ Time Frame: Baseline, Week 12 of each treatment period. ]

Central Contacts

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