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: 304
• Locations: 0 countries
• Sites: N/A

Brief Summary

A double-dummy, double-blind, randomized, parallel-group, active controlled study 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.

Conditions

Asthma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Trough FEV1 at Week 26.

  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 26

Secondary Outcomes (6)

• Change from Baseline in Trough FEV1 at Week 52

  Baseline, Week 52

• Change from Baseline in Asthma Control Questionnaire (ACQ-5) score at Week 26 and Week 52

  Baseline, Week 26, Week 52

• Change from Baseline in average Morning and Evening PEFR over 26 weeks and over 52 weeks treatment periods

  Baseline, Week 26, Week 52

• Change from Baseline in average Rescue medication use (daily, daytime, and nighttime) over 26 and 52 week treatment periods

  Baseline, Week 26, Week 52

• Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ(S)-12) total score at Week 26 and Week 52

  Baseline, Week 26, Week 52

Study Arms (2)

QVM149

EXPERIMENTAL

QVM149 (Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg ) od delivered via Breezhaler® and Placebo to Salmeterol Xinafoate 50 μg / Fluticasone Propionate 500 μg bid delivered via Girohaler®

Drug: QVM149; Drug: Placebo to Salmeterol Xinafoate / Fluticasone Propionate; Drug: Run-In Medication; Drug: Rescue Medication; Device: Concept 1 Device; Device: Girohaler

Salmeterol Xinafoate / Fluticasone Propionate Arm

ACTIVE COMPARATOR

Salmeterol Xinafoate 50 μg / Fluticasone Propionate 500 μg bid delivered via Girohaler® and Placebo to QVM149 (Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg ) od delivered via Breezhaler®.

Drug: Salmeterol Xinafoate / Fluticasone Propionate; Drug: Placebo to QVM149; Drug: Run-In Medication; Drug: Rescue Medication; Device: Concept 1 Device; Device: Girohaler

Interventions

QVM149 DRUG

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

QVM149

Salmeterol Xinafoate / Fluticasone Propionate DRUG

Salmeterol Xinafoate 50 μg / Fluticasone Propionate 500 μg bid delivered via Girohaler®

Salmeterol Xinafoate / Fluticasone Propionate Arm

Placebo to QVM149 DRUG

Placebo to QVM149: 150 μg Indacaterol Acetate / 50 μg Glycopyrronium Bromide / 160 μg Mometasone Furoate od delivered via Breezhaler®

Salmeterol Xinafoate / Fluticasone Propionate Arm

Placebo to Salmeterol Xinafoate / Fluticasone Propionate DRUG

Placebo to Salmeterol Xinafoate 50 μg / Fluticasone Propionate 500 μg bid delivered via Girohaler®

QVM149

Run-In Medication DRUG

Salmeterol Xinafoate 50 μg / Fluticasone Propionate 250μg bid delivered via Girohaler® or equivalent DPI device

QVM149; Salmeterol Xinafoate / Fluticasone Propionate Arm

Rescue Medication DRUG

Salbutamol 100μg / Albuterol 90μg

QVM149; Salmeterol Xinafoate / Fluticasone Propionate Arm

Concept 1 Device DEVICE

Concept1 (Breezhaler) used for QVM149 and placebo delivery

QVM149; Salmeterol Xinafoate / Fluticasone Propionate Arm

Girohaler DEVICE

Girohaler for Comparator and Placebo delivery.

QVM149; Salmeterol Xinafoate / Fluticasone Propionate Arm

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 subjects aged from equal to or greater than 12 years old to less than 18 years old at Screening visit.
• Written and signed informed consent by parent(s)/legal guardian(s) for the pediatric participant and assent by the pediatric participant (depending on local requirements) must be obtained before any study-specific assessment is performed.
• Patients with a documented diagnosis of persistent asthma (according to GINA 2022) for a period of at least 1 year prior to Screening.
• Subjects who have used high dose ICS with LABA in combination for asthma for at least 3 months and at stable doses for at least 1 month prior to Screening.
• Subjects must be symptomatic / inadequately controlled according to the investigator's opinion despite treatment with high stable doses of ICS with LABA in combination before Screening.
• A history of one or more documented severe asthma exacerbations within the 12 months prior to Screening that required either:
• Treatment with systemic corticosteroids (tablets, suspension or injection). OR
• Hospitalization (defined as an in subject stay or greater than 24-hour stay in an observation area in the emergency room of other equivalent facility). NOTES: Investigators must use appropriate means to ensure the accuracy of the subject's exacerbation history (subject history at Screening documented in source notes, pharmacy records, hospital records, or chart records are acceptable).
• Subjects must have ACQ-5 score equal to or greater than 1.5 at end of run-in visit prior to randomization (prior to double-blind treatment) and qualify for treatment with high dose LABA/ICS/LAMA.
• Pre-bronchodilator FEV1 equal to or greater than 60 % and \< 90 % of the predicted normal value for the subject according to ATS/ERS 2019 criteria after withholding bronchodilators (see Table 6-8) at both Run-in and before randomization.
• Withholding period of bronchodilators prior to spirometry:
• SABA for equal to or greater than 6 hours
• FDC or free combinations of ICS/LABA for equal to or greater than 48 hours
• SAMA for equal to or greater than 8 hours
• Xanthines equal to or greater than 7 days

You may not qualify if:

• Subjects who have smoked or inhaled tobacco products within the 6 months period prior to Screening, or who have a smoking history of greater than 10 pack years (Note:1 pack is equivalent to 20 cigarettes. 10 pack years = 1 pack /day x 10 yrs., or ½ pack/day x 20 yrs.) or use of nicotine inhalers such as e-cigarettes at the time of Screening.
• Subjects who have had an asthma attack/exacerbation requiring systemic steroids OR hospitalization (\> 24 hours) OR emergency room visit (≤ 24 hours) within 6 weeks of Screening. If subjects experience an asthma attack/exacerbation requiring systemic steroids or emergency room visit between Screening and end of Run-in they may be rescreened 6 weeks after recovery from the exacerbation.
• Subjects who have ever required intubation for a severe asthma attack/exacerbation.
• Subjects who have a clinical condition which is likely to be worsened by ICS administration (e.g. glaucoma, cataract and fragility fractures) who are according to investigator's medical judgment at risk participating in the study.
• Subjects who have had a respiratory tract infection or asthma worsening as determined by investigator within 4 weeks prior to Screening or between Screening and end of Run-in.
• Subjects may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.
• Subjects with evidence upon visual inspection (laboratory culture is not required) of clinically significant (in the opinion of investigator) oropharyngeal candidiasis at End of Run-in or earlier, with or without treatment. Subjects may be re-screened once their candidiasis has been treated and has resolved.
• Subjects with any chronic conditions affecting the upper respiratory tract (eg. Chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.
• Subjects 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.
• Subjects with Type I diabetes or uncontrolled Type II diabetes.
• Subjects who have a clinically significant laboratory abnormality as per investigator judgement or abnormal liver chemistry results (i.e. ALT, AST, total bilirubin, alkaline phosphatase, GGT and albumin above the upper limit of normal) before the end of run-in.
• Use of other investigational drugs within 30 days or 5 half-lives of enrollment, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
• Subjects with a history of myocardial infarction (this should be confirmed clinically by the investigator) within the previous 12 months.
• Concomitant use of agents known to prolong the QTc interval unless it can be permanently discontinued for the duration of study.
• Subjects with a history of long QT syndrome or whose QTc measured at Run-in or baseline prior to randomization (Fridericia method) is prolonged (\> 450 msec for males and \> 460 msec for females) and confirmed by a central assessor or inability to determine the QTcF interval (these subjects should not be re-screened).

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 20, 2023
• Study Start (Estimated): May 29, 2026
• Primary Completion (Estimated): December 21, 2028
• Study Completion (Estimated): December 24, 2029
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share