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.
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 outType 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.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
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