QVM149 vs Salmeterol/Fluticasone for Asthma in Teens

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.

Recruiting Phase 3 Interventional Study
Asthma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
12 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
188 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Who this trial is looking for

This trial is looking for teens aged 12 to under 18 years with asthma. Participants will compare a new treatment called QVM149 to an existing treatment. To join, participants need to meet certain health criteria related to their asthma.

Are You a Good Fit for This Trial?
Rules you out Type 1 diabetes

You may be able to join if

  • I am between 12 and 18 years old.
  • I have a diagnosis of persistent asthma for at least one year.
  • I have been using a medium or high dose of asthma medication for at least three months.
  • I am still experiencing asthma symptoms despite my current treatment.
  • I can show an improvement in my breathing after taking albuterol.
  • My lung function before treatment is at least 50% of what is expected for me.

You may not be able to join if

  • I have had a severe asthma attack needing steroids or a hospital visit in the last 6 weeks.
  • I have ever needed intubation for my asthma.
  • I have a history of other serious lung diseases.
  • I have uncontrolled diabetes.
  • I had a heart attack in the last year.
  • I have long QT syndrome or a family history of sudden cardiac death.
  • I am capable of becoming pregnant and do not agree to use contraception.
  • I used a long-acting muscarinic antagonist in the last 3 months.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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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 scre…
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Novartis Pharmaceuticals

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Novartis Pharmaceuticals

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