RECRUITING Phase 3 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT05776927

Registry updated: 2026-10-15

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Description

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.

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®

Eligibility criteria

Key Inclusion criteria: * Male and female adolescent participants aged from ≥ 12 years old to less than 18 years old at screening visit * Participants with a documented diagnosis of persistent asthma (according to Global Initiative for Asthma GINA 2024) for a period of at least 1 year prior to screening. * Participants who have used medium or high dose ICS with LABA in combination (GINA 2024) for asthma for at least 3 months and at stable doses for at least 1 month prior to screening * Participants must be symptomatic / inadequately controlled according to the Investigator's opinion despite treatment with medium or high stable doses of ICS with LABA in combination (GINA 2024) before screening * Participants who demonstrate an increase in FEV1 of ≥ 12% within 15 to 30 minutes after administration of 200-400 μg salbutamol/180-360 μg albuterol at run-in visit * Pre-bronchodilator FEV1 ≥ 50% of the predicted normal value for the participant according to American Thoracic Society/European Respiratory Society (ATS/ERS) 2019 criteria at both run-in and before randomization Key Exclusion criteria: * Participants who have had a severe asthma attack/exacerbation requiring systemic steroids OR hospitalization (\> 24 hours) OR emergency room (ER) visit (≤ 24 hours) within 6 weeks of screening. If participants experience an asthma attack/exacerbation requiring systemic steroids or emergency room visit between screening and end of run-in they may be re-screened 6 weeks after recovery from the exacerbation * Participants who have ever required intubation for a severe asthma attack/exacerbation * Participants with a history of chronic lung diseases other than asthma, including (but not limited to) sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis * Participants with Type I diabetes or uncontrolled Type II diabetes * Participants who have a clinically significant laboratory abnormality as per investigator judgement before the end of run-in * Participants with a history of myocardial infarction (this should be confirmed clinically by the Investigator) within the previous 12 months * Participants with a history of long QT syndrome or a family history of a first degree relative with sudden cardiac death under the age of 50 years, or participants whose QTc measured at run-in or at baseline (prior to randomization) (Fridericia method) is prolonged (\> 450 msec for males and \> 460 msec for females) and confirmed by a central assessor or the inability to determine the QT interval corrected by Fridericia's formula (QTcF) interval (these participants should not be re-screened) * Female participants of childbearing potential defined as all females physiologically capable of becoming pregnant (e.g. are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of contraception as defined in the exclusion criteria * Use of long-acting muscarinic antagonist (LAMA) within 3 months prior to screening Other protocol-defined inclusion/exclusion criteria may apply.

Conditions

Asthma

Locations

Novartis Investigative Site — Rosario, Santa Fe Province, Argentina
Novartis Investigative Site — Strasbourg, France
Novartis Investigative Site — Szeged, Hungary
Novartis Investigative Site — Tarnów, Poland, Poland
Novartis Investigative Site — Bialystok, Poland
Novartis Investigative Site — Krakow, Poland
Novartis Investigative Site — Lublin, Poland
Novartis Investigative Site — Piaseczno, Poland
Novartis Investigative Site — Torun, Poland
Novartis Investigative Site — Bucharest, Romania
Novartis Investigative Site — Bratislava, Mestska Cast Ruzinov, Slovakia
Novartis Investigative Site — Košice, Slovakia
Novartis Investigative Site — East London, Eastern Cape, South Africa
Novartis Investigative Site — Germiston, Gauteng, South Africa
Novartis Investigative Site — Krugersdorp, Gauteng, South Africa
Novartis Investigative Site — Lenasia, Gauteng, South Africa
Novartis Investigative Site — Paarl, Western Cape, South Africa
Novartis Investigative Site — Cape Town, South Africa
Novartis Investigative Site — Santiago Compostela, A Coruna, Spain
Novartis Investigative Site — Sabadell, Barcelona, Spain
Novartis Investigative Site — Seville, Spain
Novartis Investigative Site — Kaohsiung City, Taiwan

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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