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.

Официальное название

A Double-dummy, Double-blind, Randomized, Active Controlled, Two-way Cross-over Study With 12 Week Treatment Duration Period, 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.

Обзор

The purpose of this study is to evaluate the efficacy and safety of indacaterol acetate / glycopyrronium bromide / mometasone furoate (QVM149) compared to salmeterol xinafoate / fluticasone propionate in children from 12 to less than 18 years of age with asthma with pre-bronchodilator FEV1 ≥ 50 % of the predicted normal value for the participant.

Подробное описание

This is a double-dummy, double-blind, randomized, active controlled, two-way two-period treatment (12 weeks duration each) cross-over study.

The study duration of 36 weeks includes:

* a screening period of up to 15 days (rescue medication: short acting β2-agonist (SABA) salbutamol 100 μg or albuterol 90 μg via a Metered-Dose Inhaler (MDI) to use as-needed throughout the study). * a run-in period of 14 days (run-in medication: salmeterol xinafoate 50 μg / fluticasone propionate 250μg bid delivered via Girohaler® or equivalent DPI device) * two treatment period of 12 weeks each (either QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 µg bid, or salmeterol xinafoate/fluticasone propionate 50/500 µg bid and placebo to QVM149 150/50/160 µg od, separated by a 3 week washout period (wash-out medication: salmeterol xinafoate/fluticasone propionate 50/250 µg bid) * a safety follow up period of 30 days during which the participant will be back on standard of care treatment as appropriate.

Вмешательства

• Препарат QVM149
  QVM149: Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg once daily delivered via Breezhaler®
• Препарат Salmeterol Xinafoate / Fluticasone Propionate
  Salmeterol xinafoate 50 μg / fluticasone propionate 500 μg twice daily delivered via Girohaler®
• Препарат Placebo to QVM149
  Placebo to QVM149 150/50/160 µg once daily delivered via Breezhaler®
• Препарат Placebo to salmeterol xinafoate / fluticasone propionate
  Placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg twice daily delivered via Girohaler®

Первичные конечные точки

• Change from Baseline in Trough FEV1 [Срок оценки: Baseline, Week 12 of each treatment period.]

Вторичные конечные точки (5)

• Change from Baseline in Asthma Control Questionnaire (ACQ-5) score [Срок оценки: Baseline, Week 12 of each treatment period]
• Change from Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) total score [Срок оценки: Baseline, Week 12 of each treatment period]
• Change from Baseline in average Rescue medication use (daily, daytime, and nighttime) [Срок оценки: Baseline, Week 12 of each treatment period]
• Number and severity of reported asthma exacerbations [Срок оценки: Baseline, Week 12 of each treatment period]
• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: From first dose up to 30 days after last dose (up to 31 weeks)]

Критерии участия

Критерии включения

• Male and female adolescent participants aged from ≥ 12 years old to less than 18 years old at screening visit
• Participants with a documented diagnosis of persistent asthma (according to Global Initiative for Asthma GINA 2024) for a period of at least 1 year prior to screening.
• Participants who have used medium or high dose ICS with LABA in combination (GINA 2024) for asthma for at least 3 months and at stable doses for at least 1 month prior to screening
• Participants must be symptomatic / inadequately controlled according to the Investigator's opinion despite treatment with medium or high stable doses of ICS with LABA in combination (GINA 2024) before screening
• Participants who demonstrate an increase in FEV1 of ≥ 12% within 15 to 30 minutes after administration of 200-400 μg salbutamol/180-360 μg albuterol at run-in visit
• Pre-bronchodilator FEV1 ≥ 50% of the predicted normal value for the participant according to American Thoracic Society/European Respiratory Society (ATS/ERS) 2019 criteria at both run-in and before randomization

Критерии исключения

• Participants who have had a severe asthma attack/exacerbation requiring systemic steroids OR hospitalization (> 24 hours) OR emergency room (ER) visit (≤ 24 hours) within 6 weeks of screening. If participants experience an asthma attack/exacerbation requiring systemic steroids or emergency room visit between screening and end of run-in they may be re-screened 6 weeks after recovery from the exacerbation
• Participants who have ever required intubation for a severe asthma attack/exacerbation
• Participants 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
• Participants with Type I diabetes or uncontrolled Type II diabetes
• Participants who have a clinically significant laboratory abnormality as per investigator judgement before the end of run-in
• Participants with a history of myocardial infarction (this should be confirmed clinically by the Investigator) within the previous 12 months
• Participants with a history of long QT syndrome or a family history of a first degree relative with sudden cardiac death under the age of 50 years, or participants whose QTc measured at run-in or at baseline (prior to randomization) (Fridericia method) is prolonged (> 450 msec for males and > 460 msec for females) and confirmed by a central assessor or the inability to determine the QT interval corrected by Fridericia's formula (QTcF) interval (these participants should not be re-screened)
• Female participants of childbearing potential defined as all females physiologically capable of becoming pregnant (e.g. are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of contraception as defined in the exclusion criteria
• Use of long-acting muscarinic antagonist (LAMA) within 3 months prior to screening

Other protocol-defined inclusion/exclusion criteria may apply.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05776927 · CQVM149C2301 · 2022-502365-26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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