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.

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: QVM149; Drug: Salmeterol Xinafoate / Fluticasone Propionate; Drug: Placebo to QVM149; Drug: Placebo to salmeterol xinafoate / fluticasone propionate

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 188
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• Poland
  • Poland
    • Tarnów, Poland, Poland, 33-100
      • Recruiting
      • Novartis Investigative Site
• South Africa
  • Gauteng
    • Germiston, Gauteng, South Africa, 1401
      • Recruiting
      • Novartis Investigative Site
    • Krugersdorp, Gauteng, South Africa, 1739
      • Recruiting
      • Novartis Investigative Site
    • Lenasia, Gauteng, South Africa, 1827
      • Recruiting
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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; QVM149: Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg once daily delivered via Breezhaler®; Drug: Salmeterol Xinafoate / Fluticasone Propionate; Salmeterol xinafoate 50 μg / fluticasone propionate 500 μg twice daily delivered via Girohaler®; Drug: Placebo to QVM149; Placebo to QVM149 150/50/160 µg once daily delivered via Breezhaler®; Drug: Placebo to salmeterol xinafoate / fluticasone propionate; Placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg twice daily delivered via Girohaler®
Experimental: 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; QVM149: Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg once daily delivered via Breezhaler®; Drug: Salmeterol Xinafoate / Fluticasone Propionate; Salmeterol xinafoate 50 μg / fluticasone propionate 500 μg twice daily delivered via Girohaler®; Drug: Placebo to QVM149; Placebo to QVM149 150/50/160 µg once daily delivered via Breezhaler®; Drug: Placebo to salmeterol xinafoate / fluticasone propionate; Placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg twice daily delivered via Girohaler®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Trough FEV1	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.	Baseline, Week 12 of each treatment period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Asthma Control Questionnaire (ACQ-5) score	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.	Baseline, Week 12 of each treatment period
Change from Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) total score	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.	Baseline, Week 12 of each treatment period
Change from Baseline in average Rescue medication use (daily, daytime, and nighttime)	Rescue medication use over 12 weeks of each treatment period.	Baseline, Week 12 of each treatment period
Number and severity of reported asthma exacerbations	Asthma exacerbations over 12 weeks of each treatment period	Baseline, Week 12 of each treatment period
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)	Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.	From first dose up to 30 days after last dose (up to 31 weeks)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): January 30, 2029

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 18, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): August 26, 2026
• Last Update Submitted That Met QC Criteria: August 25, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Adolescent; Asthma; Pediatric; ICS; LABA; LAMA; Triple Combination; QVM149
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Organic Chemicals; Pharmaceutical Preparations; Polycyclic Compounds; Amines; Steroids; Fused-Ring Compounds; Alcohols; Amino Alcohols; Androstadienes; Androstenes; Androstanes; Ethanolamines; Phenethylamines; Ethylamines; Drug Combinations; Salmeterol Xinafoate; Albuterol; Fluticasone; Fluticasone-Salmeterol Drug Combination
• Other Study ID Numbers: CQVM149C2301; 2022-502365-26 (Other Identifier: EU CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No