RecruitingPhase 3NCT05562466

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

Double-blind, Randomized, Active-controlled, Two-way Cross-over Study, With 12-week Treatment Duration Per Period, to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate / Mometasone Furoate) Compared to Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma

Sponsor

Novartis Pharmaceuticals

Enrollment

200 participants

Start Date

May 11, 2023

Study Type

INTERVENTIONAL

Conditions

Asthma

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.

Eligibility

Min Age: 6 YearsMax Age: 11 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing a combination inhaler (indacaterol/mometasone, brand name QMF149) to a standard steroid inhaler (budesonide) in children aged 6 to under 12 with asthma. The goal is to see if the combination inhaler better controls asthma symptoms in this age group. **You may be eligible if...** - Your child is between 6 and 11 years old - Your child has had a confirmed asthma diagnosis for at least 12 months - Your child is currently on a low-dose inhaled corticosteroid (steroid inhaler) alone or with one other controller medication - Your child still has asthma symptoms despite current treatment (as measured by a symptom questionnaire score) - Your child's lung function meets minimum requirements - A parent or guardian can attend all study visits and help with the study procedures **You may NOT be eligible if...** - Your child's asthma is well-controlled on current therapy - Your child has severe or unstable asthma requiring emergency treatment - Your child has lung function below the study minimum Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGQMF149

QMF149 75/40 μg o.d via Breezhaler

DRUGBudesonide

Budesonide 200 μg o.d via Breezhaler

Locations(62)

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Mendoza, Argentina

Novartis Investigative Site

Graz, Austria

Novartis Investigative Site

Salzburg, Austria

Novartis Investigative Site

Sankt Pölten, Austria

Novartis Investigative Site

Rousse, Bulgaria

Novartis Investigative Site

Sevlievo, Bulgaria

Novartis Investigative Site

Bucaramanga, Santander Department, Colombia

Novartis Investigative Site

Ibague, Tolima Department, Colombia

Novartis Investigative Site

Cali, Valle del Cauca Department, Colombia

Novartis Investigative Site

Plzen Bory, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Athens, Greece

Novartis Investigative Site

Chaïdári, Greece

Novartis Investigative Site

Heraklion Crete., Greece

Novartis Investigative Site

Pátrai, Greece

Novartis Investigative Site

Thessaloniki, Greece

Novartis Investigative Site

Guatemala City, GTM, Guatemala

Novartis Investigative Site

Guatemala City, Guatemala

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Gödöllő, Hungary

Novartis Investigative Site

Szeged, Hungary

Novartis Investigative Site

Szigetvár, Hungary

Novartis Investigative Site

Brescia, BS, Italy

Novartis Investigative Site

Catania, CT, Italy

Novartis Investigative Site

Florence, FI, Italy

Novartis Investigative Site

Pavia, PV, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Naples, Italy

Novartis Investigative Site

Guadalajara, Jalisco, Mexico

Novartis Investigative Site

Guadalajara, Jalisco, Mexico

Novartis Investigative Site

San Juan del Río, Querétaro, Mexico

Novartis Investigative Site

Villahermosa, Tabasco, Mexico

Novartis Investigative Site

Querétaro, Mexico

Novartis Investigative Site

Panama City, Panama

Novartis Investigative Site

Lisbon, Portugal

Novartis Investigative Site

Lisbon, Portugal

Novartis Investigative Site

Porto, Portugal

Novartis Investigative Site

Porto, Portugal

Novartis Investigative Site

Timișoara, Timiș County, Romania

Novartis Investigative Site

Bucharest, Romania

Novartis Investigative Site

Bloemfontein, Free State, South Africa

Novartis Investigative Site

Centurion, Gauteng, South Africa

Novartis Investigative Site

Pretoria, Gauteng, South Africa

Novartis Investigative Site

Raslouw Centurion, Gauteng, South Africa

Novartis Investigative Site

Cape Town, Western Cape, South Africa

Novartis Investigative Site

George, Western Cape, South Africa

Novartis Investigative Site

Cape Town, Western Province, South Africa

Novartis Investigative Site

Cape Town, South Africa

Novartis Investigative Site

Esplugues, Barcelona, Spain

Novartis Investigative Site

Sabadell, Barcelona, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Córdoba, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Málaga, Spain

Novartis Investigative Site

Haiphong, Vietnam

Novartis Investigative Site

Hanoi, Vietnam

Novartis Investigative Site

Ho Chi Minh City, Vietnam

View Full Details on ClinicalTrials.gov

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NCT05562466

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