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.

NCT05776927 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: CQVM149C23012022-502365-26
• Study Type: interventional
• Target: 188
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Asthma

Keywords

Asthma; Adolescent; QVM149; Pediatric; LABA; LAMA; ICS; Triple Combination

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change from Baseline in Asthma Control Questionnaire (ACQ-5) score

  Baseline, Week 12 of each treatment period

• Change from Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) total score

  Baseline, Week 12 of each treatment period

• Change from Baseline in average Rescue medication use (daily, daytime, and nighttime)

  Baseline, Week 12 of each treatment period

• Number and severity of reported asthma exacerbations

  Baseline, Week 12 of each treatment period

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From first dose up to 30 days after last dose (up to 31 weeks)

Study Arms (2)

Arm 1: QVM149 first, then salmeterol xinafoate/fluticasone propionate

EXPERIMENTAL

* 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

EXPERIMENTAL

* 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

Interventions

QVM149 DRUG

QVM149: Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg once daily delivered via Breezhaler®

Arm 1: QVM149 first, then salmeterol xinafoate/fluticasone propionate; Arm 2: Salmeterol xinafoate/fluticasone propionate first, then QVM149

Salmeterol Xinafoate / Fluticasone Propionate DRUG

Salmeterol xinafoate 50 μg / fluticasone propionate 500 μg twice daily delivered via Girohaler®

Arm 1: QVM149 first, then salmeterol xinafoate/fluticasone propionate; Arm 2: Salmeterol xinafoate/fluticasone propionate first, then QVM149

Placebo to QVM149 DRUG

Placebo to QVM149 150/50/160 µg once daily delivered via Breezhaler®

Arm 1: QVM149 first, then salmeterol xinafoate/fluticasone propionate; Arm 2: Salmeterol xinafoate/fluticasone propionate first, then QVM149

Placebo to salmeterol xinafoate / fluticasone propionate DRUG

Placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg twice daily delivered via Girohaler®

Arm 1: QVM149 first, then salmeterol xinafoate/fluticasone propionate; Arm 2: Salmeterol xinafoate/fluticasone propionate first, then QVM149

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Use of long-acting muscarinic antagonist (LAMA) within 3 months prior to screening

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone-Salmeterol Drug Combination; Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All site staff, including pharmacist will be blinded. All sponsor staff will be blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A double-dummy, double-blind, randomized, active controlled study.

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 20, 2023
• Study Start: July 31, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): January 30, 2029
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share