EUCTR2016-001607-23-IT进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Children 6 to <12 Years of Age with Uncontrolled Persistent Asthma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 838
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Children 6 to <12 years of age, with a physician diagnosis of persistent asthma for =12 months prior to Screening, based on clinical history and examination, pulmonary function parameters according to Global initiative for asthma (GINA) 2015 Guidelines and the following criteria:
- •-Existing background therapy of medium-dose inhaled corticosteroids (ICS) with second controller medication (ie, long-acting ß2 agonist [LABA], leukotriene receptor antagonist [LTRA], long acting muscarinic antagonist [LAMA], or methylxanthines) or high-dose ICS alone or high dose ICS with second controller, for at least 3 months with a stable dose =1 month prior to Screening Visit 1.
- •-Pre-bronchodilator forced expiratory volume in 1 second (FEV1) =95% of predicted normal or pre bronchodilator FEV1/forced vital capacity (FVC) ratio <0.85 at Screening and Baseline Visits.
- •-Reversibility of at least 10% in FEV1 after the administration of albuterol/salbutamol or levalbuterol/levosalbutamol reliever medication before randomization. Documented reversibility or positive airway hyperresponsiveness to methacholine within 12 months prior to Screening V1 is considered acceptable.
- •-Must have experienced within 1 year prior to Screening Visit 1 a Severe Exacerbation Event.
- •- Evidence of uncontrolled asthma, with at least one of the following criteria during the 4 (±1) weeks Screening Period:
- •-Asthma Control Questionnaire–Interviewer Administered (ACQ-IA) ACQ-5 score =1.5 on at least one day of the Screening Period.
- •-Use of reliever medication (ie, albuterol/salbutamol or levalbuterol/levosalbutamol), other than as a preventive for exercise induced bronchospasm, on 3 or more days per week, in at least one week during the Screening Period.
- •-Sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening Period.
- •-Asthma symptoms 3 or more days per week in at least one week during the Screening Period.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 838
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Patients <6 or =12 years of age.
- •-Patients with <16 kg bodyweight.
- •-Any other chronic lung disease (cystic fibrosis, bronchopulmonary dysplasia, etc) which may impair lung function.
- •-A subject with any history of life threatening asthma (ie, extreme exacerbation that requires intubation).
- •-Co-morbid disease that might interfere with the evaluation of investigational medicinal product (IMP).
研究者
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