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
Not Yet 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 od delivered via Breezhaler®
  • Salmeterol Xinafoate / Fluticasone Propionate — DRUG
    Salmeterol Xinafoate 50 μg / Fluticasone Propionate 500 μg bid delivered via Girohaler®
  • Placebo to QVM149 — DRUG
    Placebo to QVM149: 150 μg Indacaterol Acetate / 50 μg Glycopyrronium Bromide / 160 μg Mometasone Furoate od delivered via Breezhaler®
  • Placebo to Salmeterol Xinafoate / Fluticasone Propionate — DRUG
    Placebo to Salmeterol Xinafoate 50 μg / Fluticasone Propionate 500 μg bid delivered via Girohaler®
  • Run-In Medication — DRUG
    Salmeterol Xinafoate 50 μg / Fluticasone Propionate 250μg bid delivered via Girohaler® or equivalent DPI device
  • Rescue Medication — DRUG
    Salbutamol 100μg / Albuterol 90μg
  • Concept 1 Device — DEVICE
    Concept1 (Breezhaler) used for QVM149 and placebo delivery
  • Girohaler — DEVICE
    Girohaler for Comparator and Placebo delivery.

Study Details

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.

Key Dates

First listed
Mar 20, 2023
Start date
May 29, 2026
Status verified
Jan 2026
Primary completion
Dec 21, 2028
Completion
Dec 24, 2029

Study Design

Enrollment
304 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: QVM149
    QVM149 (Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg ) od delivered via Breezhaler® and Placebo to Salmeterol Xinafoate 50 μg / Fluticasone Propionate 500 μg bid delivered via Girohaler®
  • Active Comparator: Salmeterol Xinafoate / Fluticasone Propionate Arm
    Salmeterol Xinafoate 50 μg / Fluticasone Propionate 500 μg bid delivered via Girohaler® and Placebo to QVM149 (Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg ) od delivered via Breezhaler®.

Primary Outcome Measure

Change from Baseline in Trough FEV1 at Week 26. [ Time Frame: Baseline, Week 26 ]

Central Contacts

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