A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma

NCT05562466 | Recruiting Phase 3 DMC

• 3 other identifiers: CQMF149G23012021-005591-192022-501899-26
• Study Type: interventional
• Target: 200
• Locations: 16 countries
• Sites: 62

Brief Summary

The purpose of this study is to evaluate the superiority in terms of efficacy and evaluate the safety of QMF149 (indacaterol (acetate) / mometasone (furoate)) compared to budesonide in children from 6 to less than 12 years of age with asthma.

• The study duration will be up to 37 weeks including an investigational treatment duration of 12 weeks and a comparator treatment duration of 12 weeks.
• The visit frequency will be 3 weeks for screening, run-in and wash-out period, 6 weeks interval for visits during each treatment period, 30 days for safety follow-up.

Conditions

Asthma

Keywords

Asthma; Pediatric; Breezhaler; QMF149; Budesonide

Outcome Measures

Primary Outcomes (1)

• Change from baseline in trough FEV1

  Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured by spirometry.

  Week 12 of each treatment period

Secondary Outcomes (5)

• Change from baseline in ACQ-IA score

  At week 12 of each treatment period

• Change from baseline in average Morning and Evening PEFR

  Over 12 weeks of each treatment period

• Change from baseline in average rescue medication use

  Over 12 weeks of each treatment period

• Annual rate of asthma exacerbations

  Over 12 weeks with each treatment

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

  From informed consent until 30 days after last dose of study treatment

Study Arms (2)

QMF149

EXPERIMENTAL

QMF149 75/40μg

Drug: QMF149

Budesonide

ACTIVE COMPARATOR

Budesonide 200μg o.d

Drug: Budesonide

Interventions

QMF149 DRUG

QMF149 75/40 μg o.d via Breezhaler

QMF149

Budesonide DRUG

Budesonide 200 μg o.d via Breezhaler

Budesonide

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female children ≥ 6 years and \<12 years in age at randomization.
• Parents/legal guardian must be willing and able to attend study visits and assist the child with the procedures outlined in the protocol (e.g. compliance with taking study medication and completing the diary) ((≥ 70% during the last 14 days of the Run-in period)).
• Confirmed/documented diagnosis of asthma, as defined by national or international asthma guidelines for at least 12 months prior to study enrollment.
• Written and signed informed consent by parent(s)/legal guardian(s) for the pediatric patient and assent by the pediatric patient (depending on local requirements) must be obtained before any study-specific assessment is performed.
• Patient receiving daily treatment of stable low dose ICS alone (i.e. up to 100ug daily dose of fluticasone propionate DPI or equivalent) without additional controller OR low dose ICS (up to 100ug daily dose of fluticasone propionate DPI or equivalent) with one additional controller prior to starting run-in and eligible after run-in on mono ICS alone (fluticasone 100ug/day) for at least 3 weeks (run-in period) prior to randomization.
• All patients must be symptomatic at randomization (Visit 30), as defined by ACQ-IA≥1.5. Patients previously on low dose ICS may be included for run-in only if ACQ-IA score ≥1.5 at Visit 20 and will be randomized if ACQ-IA score ≥1.5 at Visit 30.
• Patients previously on low dose ICS with one controller may do the wash out of the controller before the start of run-in and be included for run-in only if ACQ-IA score ≥ 1 and \<1.5 at Visit 20 and will be randomized if ACQ-IA score ≥1.5 at Visit 30.
• Pre-Bronchodilator FEV1 ≥50% of predicted normal at start of Run-in (Visit 20) and end of Run-in (Visit 30).
• Withholding period of bronchodilators prior to spirometry at all time:
• SABA for ≥ 6 hours. For loose combinations of ICS/LABA\* a wash-out of ≥ 48 hours before Visit 20 is required (14 days for once daily combinations, i.e. indacaterol), short acting anticholinergic (SAMA) for ≥ 8 hours and xanthines ≥7 days.
• \* In case of combination ICS/LABA at screening, ICS alone should be continued. Wash-out period of each drug should be adhered to as above and should not be longer. If wash-out period is considered to be longer, please contact the Novartis Medical Monitor.
• If patient fails to meet the pre FEV1 criteria for technical reasons, a rescreen is allowed once and in this circumstance, patients are not required to go back on prior medication (low dose ICS with or without controller) for the full 4 weeks duration and the rescreen can be scheduled at site's convenience. In this case all assessments must be done according to protocol's requirements.
• FEV1 bronchodilator responsiveness testing using up to 4 puffs of SABA (up to 400μg salbutamol or 360μg albuterol) at Run-in Visit (Visit 20): increase \> and/or = 12% (performed according to ATS/ERS 2019 guidelines). All patients must perform a bronchodilator responsiveness test at start of Run-in. If responsiveness is not demonstrated at Run-in, it may be repeated once on the same day. If responsiveness is still not demonstrated after repeat, documentation of historical reversibility is accepted. If not available patients must be screen failed. Spacers may be used for bronchodilator responsiveness testing.
• Demonstrate acceptable inhaler use technique with Breezhaler® at randomization, as well as acceptable use of other study devices and be able to complete spirometry procedures.
• A parent/legal guardian is to complete all e-Diary entries and attend all clinic visits with the patient. It is recommended, if possible, to have the same parent/legal guardian to complete the e-diary entries and attend clinic visits with the patient.

You may not qualify if:

• Prior intubation for asthma.
• Patients who have had a severe asthma exacerbation requiring in the previous month either systemic steroids or hospitalization due to asthma (\>24h) or emergency room visit (≤24 hours).
• Subjects receiving any medications in the classes specified in Table 6 6 unless they undergo the required washout period prior to Treatment Visit (Day 1) and follow the adjustment through the treatment period.
• Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
• History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years prior to screening, regardless of whether there is evidence of local recurrence or metastases.
• History or presence of impaired renal function as indicated by clinically significant abnormal creatinine or blood urea nitrogen (BUN) and/or urea values, or abnormal urinary constituents (e.g. albuminuria) according to investigator's judgement.
• Evidence of urinary obstruction, or difficulty in voiding
• Evidence of congenital renal abnormalities with an established effect on renal function
• Calculated eGFR \<60 mL/min/1.73m2 using the Bedside Schwartz formula.
• Patients who have had a respiratory tract infection as determined by the investigator within 4 weeks prior to Visit 1, or between Visit 1 and Visit 30.
• Patients may be re-screened once, 4 weeks after recovery from their respiratory tract infection.
• Any chronic condition of the respiratory tract which in the opinion of the investigator may interfere with study evaluation or optimal participation in the study.
• Patient with evidence upon visual inspection (laboratory culture not required) of clinically significant (upon the opinion of the investigator) oropharyngeal candidiasis at Visit 30 or earlier, with or without treatment, Patients may be rescreened once their candidiasis has been treated and has resolved.
• History of chronic lung disease other than asthma such as and not limited to, sarcoidosis interstitial lung disease, cystic fibrosis, mycobacterial or other infection (including active tuberculosis or atypical mycobacterial disease), chronic obstructive pulmonary disease (COPD) and asthma/COPD overlap syndrome (ACOS).
• Patients with a history of long QT syndrome or whose corrected QT interval (QTc) measured at start of Run-in or Baseline (Fridericia method) is prolonged (≥ 450 msec for boys and girls) and confirmed by a central assessor (these patients should not be rescreened).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (62)

Novartis Investigative Site

CABA, Buenos Aires, C1122AAK, Argentina

RECRUITING

Novartis Investigative Site

CABA, Buenos Aires, C1414AIF, Argentina

RECRUITING

Novartis Investigative Site

CABA, Buenos Aires, C1425BEN, Argentina

RECRUITING

Novartis Investigative Site

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

Novartis Investigative Site

Rosario, Santa Fe Province, S2000JKR, Argentina

RECRUITING

Novartis Investigative Site

Mendoza, 5500, Argentina

RECRUITING

Novartis Investigative Site

Graz, 8036, Austria

RECRUITING

Novartis Investigative Site

Salzburg, 5020, Austria

RECRUITING

Novartis Investigative Site

Sankt Pölten, 3100, Austria

RECRUITING

Novartis Investigative Site

Rousse, 7002, Bulgaria

RECRUITING

Novartis Investigative Site

Sevlievo, 5400, Bulgaria

RECRUITING

Novartis Investigative Site

Bucaramanga, Santander Department, 680001, Colombia

RECRUITING

Novartis Investigative Site

Ibague, Tolima Department, 730006, Colombia

RECRUITING

Novartis Investigative Site

Cali, Valle del Cauca Department, 760001, Colombia

RECRUITING

Novartis Investigative Site

Plzen Bory, 301 00, Czechia

RECRUITING

Novartis Investigative Site

Prague, 128 08, Czechia

RECRUITING

Novartis Investigative Site

Athens, 115 27, Greece

RECRUITING

Novartis Investigative Site

Chaïdári, 124 62, Greece

RECRUITING

Novartis Investigative Site

Heraklion Crete., 715 00, Greece

RECRUITING

Novartis Investigative Site

Pátrai, 265 04, Greece

RECRUITING

Novartis Investigative Site

Thessaloniki, 546 42, Greece

RECRUITING

Novartis Investigative Site

Guatemala City, GTM, 01011, Guatemala

RECRUITING

Novartis Investigative Site

Guatemala City, 01010, Guatemala

RECRUITING

Novartis Investigative Site

Budapest, 1033, Hungary

RECRUITING

Novartis Investigative Site

Gödöllő, 2100, Hungary

RECRUITING

Novartis Investigative Site

Szeged, 6720, Hungary

RECRUITING

Novartis Investigative Site

Szigetvár, 7900, Hungary

RECRUITING

Novartis Investigative Site

Brescia, BS, 25123, Italy

WITHDRAWN

Novartis Investigative Site

Catania, CT, 95123, Italy

RECRUITING

Novartis Investigative Site

Florence, FI, 50139, Italy

WITHDRAWN

Novartis Investigative Site

Pavia, PV, 27100, Italy

WITHDRAWN

Novartis Investigative Site

Roma, RM, 00161, Italy

RECRUITING

Novartis Investigative Site

Naples, 80138, Italy

RECRUITING

Novartis Investigative Site

Guadalajara, Jalisco, 44100, Mexico

RECRUITING

Novartis Investigative Site

Guadalajara, Jalisco, 44130, Mexico

RECRUITING

Novartis Investigative Site

San Juan del Río, Querétaro, 76800, Mexico

RECRUITING

Novartis Investigative Site

Villahermosa, Tabasco, 86035, Mexico

RECRUITING

Novartis Investigative Site

Querétaro, 76000, Mexico

RECRUITING

Novartis Investigative Site

Panama City, 8185, Panama

RECRUITING

Novartis Investigative Site

Lisbon, 1649-035, Portugal

RECRUITING

Novartis Investigative Site

Lisbon, 1998-018, Portugal

RECRUITING

Novartis Investigative Site

Porto, 4099-001, Portugal

WITHDRAWN

Novartis Investigative Site

Porto, 4100-180, Portugal

RECRUITING

Novartis Investigative Site

Timișoara, Timiș County, 300723, Romania

WITHDRAWN

Novartis Investigative Site

Bucharest, 050152, Romania

RECRUITING

Novartis Investigative Site

Bloemfontein, Free State, 9301, South Africa

RECRUITING

Novartis Investigative Site

Centurion, Gauteng, 0157, South Africa

RECRUITING

Novartis Investigative Site

Pretoria, Gauteng, 0181, South Africa

RECRUITING

Novartis Investigative Site

Raslouw Centurion, Gauteng, 0157, South Africa

RECRUITING

Novartis Investigative Site

Cape Town, Western Cape, 7130, South Africa

RECRUITING

Novartis Investigative Site

George, Western Cape, 6529, South Africa

RECRUITING

Novartis Investigative Site

Cape Town, Western Province, 7700, South Africa

RECRUITING

Novartis Investigative Site

Cape Town, 7531, South Africa

RECRUITING

Novartis Investigative Site

Esplugues, Barcelona, 08950, Spain

RECRUITING

Novartis Investigative Site

Sabadell, Barcelona, 08208, Spain

RECRUITING

Novartis Investigative Site

Barcelona, 08035, Spain

RECRUITING

Novartis Investigative Site

Córdoba, 14004, Spain

RECRUITING

Novartis Investigative Site

Madrid, 28034, Spain

RECRUITING

Novartis Investigative Site

Málaga, 29011, Spain

RECRUITING

Novartis Investigative Site

Haiphong, 180000, Vietnam

RECRUITING

Novartis Investigative Site

Hanoi, 100000, Vietnam

RECRUITING

Novartis Investigative Site

Ho Chi Minh City, 700000, Vietnam

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

QMF149; Budesonide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

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: Patients, investigator staff, persons performing the assessments, data analysts and the Sponsor Clinical Trial Team (CTT) will remain blind to the identity of the treatment from the time of randomization until database lock.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 30, 2022
• Study Start: May 11, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

BU (2); PA (1); VN (3); AR (6); GR (5); ME (5); GU (2); CO (3); PT (4); CZ (2); AU (3); ZA (8); HU (4); RO (2); ES (6); IT (6)