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NCT05776927From ClinicalTrials.govRecruiting

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.

A Double-dummy, Double-blind, Randomized, Active Controlled, Two-way Cross-over Study With 12 Week Treatment Duration 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.

  • Asthma

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Novartis Pharmaceuticals
Enrolment target
188
Started
4 August 2026
Main results due
30 December 2028
Study sites
21
Registry updated
28 September 2026

Can you take part?

  • Ages 12 years to 17 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(21)

  • Novartis Investigative Site

    Strasbourg, France

    Recruiting

  • Novartis Investigative Site

    Szeged, Hungary

    Recruiting

  • Novartis Investigative Site

    Tarnów, Poland, Poland

    Recruiting

  • Novartis Investigative Site

    Bialystok, Poland

    Recruiting

  • Novartis Investigative Site

    Krakow, Poland

    Recruiting

  • Novartis Investigative Site

    Lublin, Poland

    Recruiting

  • Novartis Investigative Site

    Piaseczno, Poland

    Recruiting

  • Novartis Investigative Site

    Torun, Poland

    Recruiting

  • Novartis Investigative Site

    Bucharest, Romania

    Recruiting

  • Novartis Investigative Site

    Bratislava, Mestska Cast Ruzinov, Slovakia

    Recruiting

  • Novartis Investigative Site

    Košice, Slovakia

    Recruiting

  • Novartis Investigative Site

    East London, Eastern Cape, South Africa

    Recruiting

  • Novartis Investigative Site

    Germiston, Gauteng, South Africa

    Recruiting

  • Novartis Investigative Site

    Krugersdorp, Gauteng, South Africa

    Recruiting

  • Novartis Investigative Site

    Lenasia, Gauteng, South Africa

    Recruiting

  • Novartis Investigative Site

    Paarl, Western Cape, South Africa

    Recruiting

  • Novartis Investigative Site

    Cape Town, South Africa

    Recruiting

  • Novartis Investigative Site

    Santiago Compostela, A Coruna, Spain

    Recruiting

  • Novartis Investigative Site

    Sabadell, Barcelona, Spain

    Recruiting

  • Novartis Investigative Site

    Seville, Spain

    Recruiting

  • Novartis Investigative Site

    Kaohsiung City, Taiwan

    Recruiting

Showing 21 of 21 sites. 21 of the 21 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05776927. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometaso | Trialion