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
Location: See all (57) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 11
Healthy Volunteers: f
View:

• 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.

• A one-time repeat of percent predicted FEV1 (pre-bronchodilator FEV1) within 5 days of the Visit is allowed at Visit 20 as well as Visit 30. That would provide sufficient time to receive confirmation from the spirometry data central reviewer of the validity of the assessment. At Visit 20, the Run-in medication should be dispensed only once the repeat spirometry was qualified, and if all inclusion criteria at Visit 20 are successfully met.

• 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.

⁃ Have a documented negative COVID-19 test (validated PCR or antigenic test)) within 3 days prior to randomization visit.

⁃ For optional Pharmacokinetics (PK) analysis: Participants willing to participate in the optional PK analysis will need to weigh at least 25 kg at screening.

Locations
Other Locations
Argentina
Novartis Investigative Site
RECRUITING
Caba
Novartis Investigative Site
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Caba
Novartis Investigative Site
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Caba
Novartis Investigative Site
RECRUITING
Mendoza
Novartis Investigative Site
RECRUITING
Rosario
Novartis Investigative Site
RECRUITING
Rosario
Austria
Novartis Investigative Site
RECRUITING
Graz
Novartis Investigative Site
RECRUITING
Salzburg
Novartis Investigative Site
RECRUITING
Sankt Pölten
Bulgaria
Novartis Investigative Site
RECRUITING
Rousse
Novartis Investigative Site
RECRUITING
Sevlievo
Colombia
Novartis Investigative Site
RECRUITING
Bucaramanga
Novartis Investigative Site
RECRUITING
Ibagué
Novartis Investigative Site
RECRUITING
Santiago De Cali
Greece
Novartis Investigative Site
RECRUITING
Chaïdári
Novartis Investigative Site
RECRUITING
Heraklion Crete
Novartis Investigative Site
RECRUITING
Pátrai
Novartis Investigative Site
RECRUITING
Thessaloniki
Guatemala
Novartis Investigative Site
RECRUITING
Guatemala City
Novartis Investigative Site
RECRUITING
Guatemala City
Hungary
Novartis Investigative Site
RECRUITING
Budapest
Novartis Investigative Site
RECRUITING
Gödöllő
Novartis Investigative Site
RECRUITING
Szeged
Novartis Investigative Site
RECRUITING
Szigetvár
Italy
Novartis Investigative Site
RECRUITING
Brescia
Novartis Investigative Site
RECRUITING
Catania
Novartis Investigative Site
RECRUITING
Florence
Novartis Investigative Site
RECRUITING
Napoli
Novartis Investigative Site
RECRUITING
Pavia
Novartis Investigative Site
RECRUITING
Roma
Mexico
Novartis Investigative Site
RECRUITING
Guadalajara
Novartis Investigative Site
RECRUITING
Guadalajara
Novartis Investigative Site
RECRUITING
Querétaro
Novartis Investigative Site
RECRUITING
San Juan Del Río
Novartis Investigative Site
RECRUITING
Villahermosa
Panama
Novartis Investigative Site
RECRUITING
Panama City
Portugal
Novartis Investigative Site
RECRUITING
Lisbon
Novartis Investigative Site
WITHDRAWN
Porto
Novartis Investigative Site
RECRUITING
Porto
Romania
Novartis Investigative Site
RECRUITING
Bucharest
Novartis Investigative Site
WITHDRAWN
Timișoara
South Africa
Novartis Investigative Site
RECRUITING
Bloemfontein
Novartis Investigative Site
RECRUITING
Cape Town
Novartis Investigative Site
RECRUITING
Cape Town
Novartis Investigative Site
RECRUITING
Cape Town
Novartis Investigative Site
RECRUITING
George
Novartis Investigative Site
RECRUITING
Pretoria
Novartis Investigative Site
RECRUITING
Raslouw Centurion
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Córdoba
Novartis Investigative Site
RECRUITING
Esplugues De Llobregat
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Málaga
Novartis Investigative Site
RECRUITING
Sabadell
Viet Nam
Novartis Investigative Site
RECRUITING
Haiphong
Novartis Investigative Site
RECRUITING
Hanoi
Novartis Investigative Site
RECRUITING
Ho Chi Minh City
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Backup
Novartis Pharmaceuticals
Time Frame
Start Date: 2023-05-11
Estimated Completion Date: 2028-05-30
Participants
Target number of participants: 200
Treatments
Experimental: QMF149
QMF149 75/40μg
Active_comparator: Budesonide
Budesonide 200μg o.d
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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