A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromi… (NCT05776927) | Clinical Trial Compass
RecruitingPhase 3
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.
South Africa188 participantsStarted 2026-08-04
Plain-language summary
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.
Who can participate
Age range
12 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 fr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares a three-drug inhaler called QVM149 against the combination of salmeterol and fluticasone, which my child may already be familiar with — can you help me understand how the two approaches differ and whether either might be a better fit for where my child is right now in their asthma treatment?
2The trial is measuring something called 'trough FEV1,' which I understand is a lung function test taken at the lowest point before the next dose — how meaningful is that measurement for day-to-day asthma control in a teenager, and what would a meaningful change actually look like for my child?
3Since this is a Phase 3 trial specifically for 12- to 17-year-olds, does that mean there's already safety and efficacy data from adults that we can look at, and how does that affect what we might expect for my child if they were to participate?
4The trial isn't recruiting yet — given my child's current asthma management, does it make more sense to adjust their existing treatment now, or would it be worth waiting to see if this trial opens and whether they might be eligible to discuss with the team at that point?
5QVM149 combines three medications in one inhaler — what are the known or potential risks of adding a third drug like mometasone on top of the long-acting bronchodilators, especially for a teenager whose lungs are still developing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Trough FEV1
Timeframe: Baseline, Week 12 of each treatment period.