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New triple inhaler could simplify asthma care for teens

NCT ID NCT05776927

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 9 times

Summary

This study tests a new once-daily inhaler called QVM149, which combines three medicines (indacaterol, glycopyrronium, and mometasone furoate) to control asthma. It will enroll 304 teenagers aged 12 to 17 and compare the new inhaler to a standard twice-daily treatment (salmeterol/fluticasone). The main goal is to see if QVM149 improves lung function over 26 weeks, with follow-up for up to a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
QVM149 (a combination of indacaterol, glycopyrronium, and mometasone furoate) delivered via inhaler
What this could lead to
If successful, this could offer a more effective once-daily inhaler option for teenagers with asthma, potentially improving lung function and symptom control compared to current twice-daily treatments.
What could go wrong
This is a Phase 3 trial, so it's further along, but it's still testing a new combination. It may not prove superior to existing treatments, and side effects like throat irritation or increased heart rate are possible. Results may not apply to all asthma severities.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 188 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Novartis Investigative Site

    RECRUITING

    Strasbourg, 67091, France

  • Novartis Investigative Site

    RECRUITING

    Szeged, 6720, Hungary

  • Novartis Investigative Site

    RECRUITING

    Tarnów, Poland, 33-100, Poland

  • Novartis Investigative Site

    RECRUITING

    Bialystok, 15-698, Poland

  • Novartis Investigative Site

    RECRUITING

    Krakow, 31-625, Poland

  • Novartis Investigative Site

    RECRUITING

    Lublin, 20-637, Poland

  • Novartis Investigative Site

    RECRUITING

    Piaseczno, 05-500, Poland

  • Novartis Investigative Site

    RECRUITING

    Torun, 87-100, Poland

  • Novartis Investigative Site

    RECRUITING

    Bucharest, 050159, Romania

  • Novartis Investigative Site

    RECRUITING

    Bratislava, Mestska Cast Ruzinov, 821 08, Slovakia

  • Novartis Investigative Site

    RECRUITING

    East London, Eastern Cape, 5201, South Africa

  • Novartis Investigative Site

    RECRUITING

    Germiston, Gauteng, 1401, South Africa

  • Novartis Investigative Site

    RECRUITING

    Krugersdorp, Gauteng, 1739, South Africa

  • Novartis Investigative Site

    RECRUITING

    Lenasia, Gauteng, 1827, South Africa

  • Novartis Investigative Site

    RECRUITING

    Paarl, Western Cape, 7626, South Africa

  • Novartis Investigative Site

    RECRUITING

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    RECRUITING

    Sabadell, Barcelona, 08208, Spain

  • Novartis Investigative Site

    RECRUITING

    Seville, 41013, Spain

  • Novartis Investigative Site

    RECRUITING

    Kaohsiung City, 833, Taiwan

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