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

Asthma Clinical Trial

Official title:
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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This is a double-blind, randomized, active controlled, 2 period, 2 treatment (12 weeks duration each) cross-over multi-center study to evaluate the efficacy and safety of indacaterol (acetate)/ mometasone (furoate) compared to budesonide in terms of superiority in children from 6 to less than 12 years of age with asthma with FEV1 ≥50% of the predicted normal value for the participant. The study duration of 37 weeks includes: - a screening period of up to 3 weeks - a run-in period of 3 weeks (run-in medication: Fluticasone propionate 50μg bid) - a first treatment period of 12 weeks (either with QMF149 75/40μg o.d or budesonide 200 μg o.d via Breezhaler) - a wash out period of 3 weeks (wash-out medication: Fluticasone propionate 50μg bid) - a second treatment period of 12 weeks (cross over of the 2 treatment groups with either QMF149 75/40μg o.d or budesonide 200 μg o.d via Breezhaler) - a safety follow-up period of 4 weeks during which the patient will be back on standard of care treatment as appropriate At the completion of the follow-up period, patient's safety information as well as survival status will be collected. ;

Study Design

Related Conditions & MeSH terms

Asthma

Clinical Trial Details

NCT number	NCT05562466
Study type	Interventional
Source	Novartis
Contact	Novartis Pharmaceuticals
Phone	+41613241111
Email	novartis.email@novartis.com
Status	Recruiting
Phase	Phase 3
Start date	May 11, 2023
Completion date	June 11, 2026

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04410523` - Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma	Phase 2
Completed	`NCT04624425` - Additional Effects of Segmental Breathing In Asthma	N/A
Active, not recruiting	`NCT03927820` - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
Completed	`NCT04617015` - Defining and Treating Depression-related Asthma	Early Phase 1
Recruiting	`NCT03694158` - Investigating Dupilumab's Effect in Asthma by Genotype	Phase 4
Terminated	`NCT04946318` - Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma	Phase 2
Completed	`NCT04450108` - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients	N/A
Completed	`NCT03086460` - A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)	Phase 2
Completed	`NCT01160224` - Oral GW766944 (Oral CCR3 Antagonist)	Phase 2
Completed	`NCT03186209` - Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)	Phase 3
Completed	`NCT02502734` - Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma	Phase 3
Completed	`NCT01715844` - L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics	Phase 1
Terminated	`NCT04993443` - First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036	Phase 1
Completed	`NCT02787863` - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology	Phase 4
Recruiting	`NCT06033833` - Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study	Phase 2
Completed	`NCT03257995` - Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.	Phase 2
Completed	`NCT02212483` - Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients	N/A
Recruiting	`NCT04872309` - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Withdrawn	`NCT01468805` - Childhood Asthma Reduction Study	N/A
Recruiting	`NCT05145894` - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.