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Efficacy and safety of indacaterol acetate (combined with glycopyrronium bromide and mometasone furoate) versus salmeterol/fluticasone in adolescents with asthma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on asthma in children and teenagers aged 12 to under 18 years. It compares a new inhaled medicine called QVM149, which contains three active ingredients (mometasone furoate, glycopyrronium bromide, and indacaterol acetate), with an established inhaler that combines salmeterol/fluticasone. The purpose is to determine whether the new combination provides better improvement in lung function after 12 weeks of treatment.

Participants will receive one of the two treatments for a 12‑week period and then switch to the other treatment for another 12‑week period. The design is double‑blind, meaning neither the participants nor the study staff know which inhaler is active, and a double‑dummy approach ensures each person uses two inhalers (one containing the active drug and one containing a placebo) so the experience is the same. During the study, lung function is measured with a test called FEV1, which assesses how much air can be exhaled in one second, and participants complete a short questionnaire about asthma control called ACQ‑5 and another questionnaire about quality of life called PAQLQ. Safety is monitored by recording any side effects and by checking basic blood tests and other routine examinations.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit

    You attend the first clinic appointment after joining the study. during this visit you receive information about the study procedures, sign the consent form, and undergo initial measurements of lung function called fev1.

    You are assigned a random treatment order. the study uses a double‑dummy design, meaning you will receive both an active inhaler and a matching placebo inhaler, but you will not know which contains the study medication.

  2. Step 2

    Start first 12‑week treatment period

    You begin the first 12‑week treatment period according to the randomised order.

    If you are assigned to the qvm149 arm, you use the inhaler once each morning. each dose contains 150 µg mometasone furoate, 50 µg glycopyrronium bromide and 160 µg indacaterol acetate. the inhaler is a dry‑powder capsule that you inhale through the mouth.

    If you are assigned to the comparator arm, you use the inhaler twice daily, morning and evening. each inhalation delivers 50 µg fluticasone propionate and 500 µg salmeterol. the inhaler is a pre‑dispensed powder.

    In both arms you also use a matching placebo inhaler to keep the dosing schedule identical. the placebo contains no active drug.

  3. Step 3

    Background asthma medications

    You continue your regular asthma controller medication, which is the seretide accuhaler. this inhaler provides fluticasone propionate and salmeterol and is taken as prescribed by your usual routine.

    For sudden breathing difficulties you keep the ventolin rescue inhaler, which contains 800 µg salbutamol per dose. you use it only when you experience symptoms such as wheezing or shortness of breath.

  4. Step 4

    Daily medication routine

    Each day you follow the dosing schedule assigned to you:

    • for qvm149 – one inhalation in the morning.
    • for the comparator – one inhalation in the morning and one in the evening.
    • the matching placebo inhaler is taken at the opposite times to keep the total number of inhalations the same.

    You record any use of the rescue inhaler in a diary provided by the study team.

  5. Step 5

    Clinic visits during first period

    You attend scheduled clinic visits at regular intervals (typically every four weeks) to allow the study staff to measure lung function, collect safety information, and review your diary.

    During these visits you may complete questionnaires such as the asthma control questionnaire (acq‑5) and the pediatric asthma quality of life questionnaire (paqlq).

  6. Step 6

    End of first 12‑week period and wash‑out

    After 12 weeks you return to the clinic for a final assessment of the first period. the results of lung function, questionnaire scores, and rescue medication use are recorded.

    A short wash‑out period is then observed, during which you stop the study inhalers but continue your regular background medication. this allows any effects of the first treatment to clear before starting the next period.

  7. Step 7

    Start second 12‑week treatment period

    You begin the second 12‑week treatment period, receiving the medication that was not given in the first period.

    The dosing schedule mirrors the first period: if you previously used qvm149, you now use the comparator inhaler twice daily with matching placebo once daily, and vice versa.

  8. Step 8

    Daily routine and clinic visits in second period

    You continue the same daily inhalation routine as described for the first period, including use of the rescue inhaler as needed.

    Clinic visits are repeated at the same intervals to assess lung function, safety parameters, and questionnaire responses.

  9. Step 9

    Final study completion

    At the end of the second 12‑week period you attend a final clinic visit. all study assessments are performed, including lung function measurement, safety lab tests, and collection of your rescue‑inhaler diary.

    After this visit the study medication is stopped and you return to your usual asthma management plan.

Who can join the trial?

12 criteria

  • Age: You must be at least 12 years old but younger than 18 years at the time of the screening visit.
  • Inhaler, peak flow meter, and spirometry use: You need to show that you can correctly use your inhaler, a peak flow meter (a hand‑held device that measures how fast you can blow air out), and spirometry (a test that measures lung function) during the initial run‑in period.
  • Medication compliance: You must take at least 70% of your prescribed asthma controller medicine (a combination of inhaled corticosteroid ICS and long‑acting beta‑agonist LABA) during the run‑in period. This means you take the medicine on at least 70 out of 100 days.
  • eDiary compliance: You must complete at least 70% of the daily electronic diary entries during the run‑in period, including at least 7 mornings and 7 evenings.
  • Informed consent: A parent or legal guardian must sign a written consent form, and you must also give your assent (agree) to take part in the study before any study procedures begin.
  • Persistent asthma diagnosis: You must have a documented diagnosis of persistent asthma for at least one year before the screening visit.
  • Stable medium or high dose treatment: You must have been using a medium‑ or high‑dose inhaled corticosteroid together with a LABA for at least three months, and the dose must have been stable (unchanged) for at least one month before screening.
  • Inadequately controlled symptoms: Despite being on the stable medium or high dose treatment, you must still have symptoms or poor asthma control, as judged by the investigator.
  • Severe asthma exacerbation history: In the past 12 months you must have had at least one severe asthma attack that required either (a) a course of systemic corticosteroids (steroid pills, liquid, or injection) or (b) a hospital stay of more than 24 hours.
  • ACQ‑5 score: At the end of the run‑in you must have an Asthma Control Questionnaire‑5 score of 1.5 or higher, which indicates that your asthma is not well controlled.
  • Lung function (FEV1) requirement: Before randomization you must have a pre‑bronchodilator FEV1 (the amount of air you can force out in one second) that is at least 50% of the predicted normal value for someone your age, height, and sex, after stopping short‑acting rescue medicines for the required washout times.
  • Reversibility test: During the run‑in you must show that your FEV1 increases by at least 12% within 15–30 minutes after taking a short‑acting bronchodilator (salbutamol or albuterol). If this is not shown, you may still be eligible if you have a documented positive test from the past two years.

Who cannot join the trial?

10 criteria

  • Smoked or used any tobacco product within the last 6 months, or have a smoking history of more than 10 pack‑years (one pack‑year means smoking one pack of 20 cigarettes every day for one year; for example, half a pack per day for 20 years also equals 10 pack‑years).
  • Have a laboratory test result that the doctor considers clearly abnormal before the run‑in period ends.
  • Had a severe asthma attack that needed systemic steroids (steroids taken by mouth or injection), or required a hospital stay longer than 24 hours, or an emergency‑room visit (up to 24 hours) within 6 weeks before screening.
  • Ever needed intubation (placement of a breathing tube) because of a severe asthma attack.
  • Have a medical condition that could get worse with inhaled corticosteroids (ICS), such as glaucoma (eye pressure problem), cataract (clouding of the eye lens), or fragility fractures (bones that break easily).
  • Had a respiratory (lung) infection or worsening of asthma within 4 weeks before screening or during the run‑in period.
  • Show signs of oropharyngeal candidiasis (oral thrush) when examined, even if it is being treated.
  • Have any long‑lasting condition affecting the upper airway, such as chronic sinusitis, that could interfere with the study.
  • Have other chronic lung diseases besides asthma, including sarcoidosis, interstitial lung disease, cystic fibrosis, significant bronchiectasis, or active tuberculosis.
  • Have type I diabetes or type II diabetes that is not well controlled.
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Investigated drugs

QVM149
QVM149 is an inhaled medication that combines three types of drugs: an inhaled steroid to reduce inflammation in the airways, a long‑acting bronchodilator that helps keep the airways open, and a long‑acting muscarinic antagonist that also helps relax the airway muscles. In this study it is taken once daily using a Breezhaler device and is being tested to see if it works better than the standard treatment for controlling asthma in teenagers. AirFluSal Forspiro
AirFluSal Forspiro is an inhaled powder that contains two medicines: an inhaled steroid that lowers airway inflammation and a long‑acting bronchodilator that helps keep the airways open. It is used twice daily and serves as the active comparator in this trial, meaning the researchers are comparing the new QVM149 medication against this established asthma treatment. Seretide Accuhaler
Seretide Accuhaler is a pre‑filled inhaler that also delivers an inhaled steroid together with a long‑acting bronchodilator. In the study it is given as part of the background therapy that participants continue to use, providing standard asthma maintenance treatment while the study drugs are being tested. Ventolin Evohaler
Ventolin Evohaler is a pressurised inhaler that provides a short‑acting bronchodilator. It works quickly to relieve sudden asthma symptoms such as wheezing or shortness of breath. In this trial it is used as a rescue inhaler that participants can take as needed for rapid symptom relief.

What is already known about the treatment

  • QVM149

    QVM149 is an inhalation powder delivered in a hard‑capsule Breezhaler that patients inhale once daily. It combines three approved drugs – mometasone furoate (a corticosteroid), glycopyrronium bromide (a long‑acting anticholinergic), and indacaterol acetate (a long‑acting beta2‑agonist) – all of which are listed in current asthma treatment guidelines. The three agents work together to lower airway inflammation, keep airway muscles relaxed, and maintain open airways throughout the day. Pharmacologically it is classified as an inhaled corticosteroid/long‑acting muscarinic antagonist/long‑acting beta2‑agonist triple therapy.

  • AirFluSal Forspiro

    AirFluSal Forspiro is an inhalation powder pre‑dispensed in a device that delivers 50 µg fluticasone propionate and 500 µg salmeterol per actuation, taken twice daily by inhalation. Both ingredients are approved and widely studied for asthma maintenance therapy. Fluticasone reduces inflammation in the airways, while salmeterol activates beta2 receptors to relax airway muscles and improve breathing. It is classified as an inhaled corticosteroid/long‑acting beta2‑agonist (ICS/LABA) combination.

  • Seretide Accuhaler

    Seretide Accuhaler provides an inhalation powder pre‑dispensed in an Accuhaler device, delivering fluticasone propionate and salmeterol together twice daily by inhalation. The product is approved and commonly used worldwide for long‑term asthma control. Fluticasone works by decreasing airway inflammation, and salmeterol keeps the airways open by stimulating beta2 receptors on smooth muscle. Its pharmacological class is inhaled corticosteroid plus long‑acting beta2‑agonist (ICS/LABA) fixed‑dose combo.

  • Ventolin Evohaler

    Ventolin Evohaler is a pressurised metered‑dose inhaler that releases 100 µg of salbutamol per puff, inhaled as needed for quick relief. Salbutamol is an approved short‑acting bronchodilator widely used in asthma treatment. It rapidly relaxes airway smooth muscle by activating beta2 receptors, providing fast symptom relief. The drug belongs to the short‑acting beta2‑agonist (SABA) class.

Investigated diseases

Asthma - Asthma is a chronic condition that causes the airways in the lungs to become inflamed and overly sensitive. The inflamed airways narrow, making it harder for air to flow in and out. People with asthma may notice wheezing, shortness of breath, chest tightness, and coughing, especially during physical activity or exposure to triggers such as dust, pollen, or cold air. Over time, repeated episodes can lead to increased airway responsiveness and more frequent symptoms. The condition often follows a pattern of periods with few symptoms alternating with times when symptoms become more noticeable.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2022-502365-26-00Protocol codeCQVM149C2301Estimated enrolment108 patientsSponsorNovartis Pharma AG

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