NCT05776927招募中3 期
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.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 188
- 试验地点
- 18
- 主要终点
- Change from Baseline in Trough FEV1 at Week 26.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All site staff, including pharmacist will be blinded. All sponsor staff will be blinded.
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Arm 1: QVM149 first, then salmeterol xinafoate/fluticasone propionate
Experimental
- QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg bid during treatment period 1.
- Then, after a 3-week washout period, salmeterol xinafoate/fluticasone propionate 50/500 μg bid and placebo to QVM149 150/50/160 µg od during treatment period 2.
干预措施: Placebo to QVM149 (Drug)
Arm 2: Salmeterol xinafoate/fluticasone propionate first, then QVM149
Experimental
- Salmeterol xinafoate/fluticasone propionate 50/500 μg bid and placebo to QVM149 150/50/160 µg od during treatment period 1.
- Then, after a 3-week washout period, QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg bid during treatment period 2.
干预措施: Placebo to QVM149 (Drug)
Arm 1: QVM149 first, then salmeterol xinafoate/fluticasone propionate
Experimental
- QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg bid during treatment period 1.
- Then, after a 3-week washout period, salmeterol xinafoate/fluticasone propionate 50/500 μg bid and placebo to QVM149 150/50/160 µg od during treatment period 2.
干预措施: QVM149 (Drug)
Arm 1: QVM149 first, then salmeterol xinafoate/fluticasone propionate
Experimental
- QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg bid during treatment period 1.
- Then, after a 3-week washout period, salmeterol xinafoate/fluticasone propionate 50/500 μg bid and placebo to QVM149 150/50/160 µg od during treatment period 2.
干预措施: Placebo to salmeterol xinafoate / fluticasone propionate (Drug)
Arm 1: QVM149 first, then salmeterol xinafoate/fluticasone propionate
Experimental
- QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg bid during treatment period 1.
- Then, after a 3-week washout period, salmeterol xinafoate/fluticasone propionate 50/500 μg bid and placebo to QVM149 150/50/160 µg od during treatment period 2.
干预措施: Salmeterol Xinafoate / Fluticasone Propionate (Drug)
Arm 2: Salmeterol xinafoate/fluticasone propionate first, then QVM149
Experimental
- Salmeterol xinafoate/fluticasone propionate 50/500 μg bid and placebo to QVM149 150/50/160 µg od during treatment period 1.
- Then, after a 3-week washout period, QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg bid during treatment period 2.
干预措施: QVM149 (Drug)
Arm 2: Salmeterol xinafoate/fluticasone propionate first, then QVM149
Experimental
- Salmeterol xinafoate/fluticasone propionate 50/500 μg bid and placebo to QVM149 150/50/160 µg od during treatment period 1.
- Then, after a 3-week washout period, QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg bid during treatment period 2.
干预措施: Salmeterol Xinafoate / Fluticasone Propionate (Drug)
Arm 2: Salmeterol xinafoate/fluticasone propionate first, then QVM149
Experimental
- Salmeterol xinafoate/fluticasone propionate 50/500 μg bid and placebo to QVM149 150/50/160 µg od during treatment period 1.
- Then, after a 3-week washout period, QVM149 150/50/160 µg od and placebo to salmeterol xinafoate/fluticasone propionate 50/500 μg bid during treatment period 2.
干预措施: Placebo to salmeterol xinafoate / fluticasone propionate (Drug)
结局指标
主要结局
Change from Baseline in Trough FEV1 at Week 26.
时间窗: Baseline, Week 26
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Change from Baseline in Trough FEV1
时间窗: Baseline, Week 12 of each treatment period.
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
次要结局
- Change from Baseline in Trough FEV1 at Week 52(Baseline, Week 52)
- Change from Baseline in Asthma Control Questionnaire (ACQ-5) score at Week 26 and Week 52(Baseline, Week 26, Week 52)
- Change from Baseline in average Morning and Evening PEFR over 26 weeks and over 52 weeks treatment periods(Baseline, Week 26, Week 52)
- Change from Baseline in average Rescue medication use (daily, daytime, and nighttime) over 26 and 52 week treatment periods(Baseline, Week 26, Week 52)
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)(From first dose up to 30 days after last dose (up to 56 weeks))
- Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ(S)-12) total score at Week 26 and Week 52(Baseline, Week 26, Week 52)
- Change from Baseline in Asthma Control Questionnaire (ACQ-5) score(Baseline, Week 12 of each treatment period)
- Change from Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) total score(Baseline, Week 12 of each treatment period)
- Change from Baseline in average Rescue medication use (daily, daytime, and nighttime)(Baseline, Week 12 of each treatment period)
- Number and severity of reported asthma exacerbations(Baseline, Week 12 of each treatment period)
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)(From first dose up to 30 days after last dose (up to 31 weeks))
研究者
研究点 (18)
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