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.
Asthma
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Phase 3
- Age range
- 12 years - 17 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 188 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
This is a double-dummy, double-blind, randomized, active controlled, two-way two-period treatment (12 weeks duration each) cross-over study.
The study duration of 36 weeks includes:
- a screening period of up to 15 days (rescue medication: short acting β2-agonist (SABA) salbutamol 100 μg or albuterol 90 μg via a Metered-Dose Inhaler (MDI) to use as-needed throughout the study).
- a run-in period of 14 days (run-in medication: salmeterol xinafoate 50 μg / fluticasone propionate 250μg bid delivered via Girohaler® or equivalent DPI device)
- two treatment period of 12 weeks each (either QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 µg bid, or salmeterol xinafoate/fluticasone propionate 50/500 µg bid and placebo to QVM149 150/50/160 µg od, separated by a 3 week washout period (wash-out medication: salmeterol xinafoate/fluticasone propionate 50/250 µg bid)
- a safety follow up period of 30 days during which the participant will be back on standard of care treatment as appropriate.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Quadruple masked
Arm 1: QVM149 first, then salmeterol xinafoate/fluticasone propionate
- QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg bid during treatment period 1.
- Then, after a 3-week washout period, salmeterol xinafoate/fluticasone propionate 50/500 μg bid and placebo to QVM149 150/50/160 µg od during treatment period 2.
Drug: QVM149 · Drug: Salmeterol Xinafoate / Fluticasone Propionate · Drug: Placebo to QVM149 · Drug: Placebo to salmeterol xinafoate / fluticasone propionate
Arm 2: Salmeterol xinafoate/fluticasone propionate first, then QVM149
- Salmeterol xinafoate/fluticasone propionate 50/500 μg bid and placebo to QVM149 150/50/160 µg od during treatment period 1.
- Then, after a 3-week washout period, QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg bid during treatment period 2.
Drug: QVM149 · Drug: Salmeterol Xinafoate / Fluticasone Propionate · Drug: Placebo to QVM149 · Drug: Placebo to salmeterol xinafoate / fluticasone propionate
QVM149 DRUG
QVM149: Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg once daily delivered via Breezhaler®
Salmeterol Xinafoate / Fluticasone Propionate DRUG
Salmeterol xinafoate 50 μg / fluticasone propionate 500 μg twice daily delivered via Girohaler®
Placebo to QVM149 DRUG
Placebo to QVM149 150/50/160 µg once daily delivered via Breezhaler®
Placebo to salmeterol xinafoate / fluticasone propionate DRUG
Placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg twice daily delivered via Girohaler®
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Change from Baseline in Trough FEV1
Time frame: Baseline, Week 12 of each treatment period.
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Secondary measures
Change from Baseline in Asthma Control Questionnaire (ACQ-5) score
Time frame: Baseline, Week 12 of each treatment period
The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. ACQ-5 score range from 0 to 6. Higher scores indicates worsening of condition.
Change from Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) total score
Time frame: Baseline, Week 12 of each treatment period
Pediatric Asthma Quality of Life Questionnaire is a 23-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma, with 7-point scale (7-not bothered at all, 1-extremely bothered). It consists of 3 domains: symptoms, activity limitation and emotional function. Higher scores indicate less impairment in HRQOL.
The overall PAQLQ score is the mean of all 23 responses and the individual domain scores are the means of the items in those domains.
Change from Baseline in average Rescue medication use (daily, daytime, and nighttime)
Time frame: Baseline, Week 12 of each treatment period
Rescue medication use over 12 weeks of each treatment period.
Number and severity of reported asthma exacerbations
Time frame: Baseline, Week 12 of each treatment period
Asthma exacerbations over 12 weeks of each treatment period
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From first dose up to 30 days after last dose (up to 31 weeks)
Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (27)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
27 locations
Novartis Investigative SiteRosario, Santa Fe Province, ArgentinaRecruiting
Novartis Investigative SiteStrasbourg, FranceRecruiting
Novartis Investigative SiteWesel, North Rhine-Westphalia, GermanyRecruiting
Novartis Investigative SiteBielefeld, GermanyRecruiting
Novartis Investigative SiteSzeged, HungaryRecruiting
Novartis Investigative SiteTarnów, Poland, PolandRecruiting
Novartis Investigative SiteBialystok, PolandRecruiting
Novartis Investigative SiteKrakow, PolandRecruiting
Novartis Investigative SiteLublin, PolandRecruiting
Novartis Investigative SitePiaseczno, PolandRecruiting
Novartis Investigative SiteTorun, PolandRecruiting
Novartis Investigative SiteBucharest, RomaniaRecruiting
Novartis Investigative SiteBratislava, Mestska Cast Ruzinov, SlovakiaRecruiting
Novartis Investigative SiteBanská Bystrica, SlovakiaRecruiting
Novartis Investigative SiteBratislava, SlovakiaRecruiting
Novartis Investigative SiteKošice, SlovakiaRecruiting
Novartis Investigative SiteEast London, Eastern Cape, South AfricaRecruiting
Novartis Investigative SiteGermiston, Gauteng, South AfricaRecruiting
Novartis Investigative SiteKrugersdorp, Gauteng, South AfricaRecruiting
Novartis Investigative SiteLenasia, Gauteng, South AfricaRecruiting
Novartis Investigative SitePaarl, Western Cape, South AfricaRecruiting
Novartis Investigative SiteCape Town, South AfricaRecruiting
Novartis Investigative SitePretoria, South AfricaRecruiting
Novartis Investigative SiteSantiago Compostela, A Coruna, SpainRecruiting
Novartis Investigative SiteSabadell, Barcelona, SpainRecruiting
Novartis Investigative SiteSeville, SpainRecruiting
Novartis Investigative SiteKaohsiung City, TaiwanRecruiting
Study team and timeline
- Lead sponsor
- Novartis Pharmaceuticals
- Study start
- Aug 4, 2026 Actual
- Primary completion
- Dec 30, 2028 Estimated
- Study completion
- Jan 30, 2029 Estimated
- First posted
- Mar 20, 2023 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
A Double-dummy, Double-blind, Randomized, Active Controlled, Two-way Cross-over Study With 12 Week Treatment Duration Period, to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Compared to Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026