EUCTR2017-001272-40-SE进行中（未招募）1 期
A 12-week, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of QAW039 when added to standard-of-care asthma therapy in patients with uncontrolled asthma - ZEA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 650
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
- •-A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months.
- •-Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose ICS plus long-acting beta agonist (LABA), or low dose ICS plus leukotriene receptor antagonist (LTRA), or medium dose ICS plus LABA for at least 3 months prior to Visit 1 and the doses have been stable for at least 4 weeks prior to Visit 1.
- •-FEV1 of =85% for patients aged =18 years. FEV1 of =90% for patients aged 12 to <18 years.
- •-Daytime asthma symptom score (0 to 6 scale) of =1 per day during 4 of the last 7 days of the placebo run-in period.
- •-Total daily SABA use =1 puff per day during 4 of the last 7 days of the placebo run-in period.
- •-Demonstrated reversible airway obstruction.
- •-Asthma control questionnaire (ACQ) score = 1.5.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 65
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 455
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 130
排除标准
- •-Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
- •-A resting QTcF (Fridericia) =450 msec (male) or =460 msec (female).
- •-Pregnant or nursing (lactating) women.
- •-Serious co-morbidities.
- •-Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin.
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