EUCTR2017-001272-40-ES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
ovartis Farmacéutica, S.A.0 个研究点目标入组 650 人开始时间: 2017年11月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
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.
研究者
相似试验
进行中（未招募）
不适用
A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexateActive Rheumatoid ArthritisEUCTR2006-001550-27-DEovartis Pharma AG293
进行中（未招募）
1 期
Study of efficacy and safety of CSJ117 in patients with severe uncontrolled asthmaAsthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2019-004905-29-HUovartis Pharma AG625
进行中（未招募）
1 期
Study of efficacy and safety of CSJ117 in patients with severe uncontrolled asthmaAsthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2019-004905-29-DEovartis Pharma AG625
进行中（未招募）
1 期
Study of efficacy and safety of CSJ117 in patients with severe uncontrolled asthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersAsthmaEUCTR2019-004905-29-LVovartis Pharma AG625
进行中（未招募）
1 期
Study of efficacy and safety of CSJ117 in patients with severe uncontrolled asthmaAsthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2019-004905-29-PLovartis Pharma AG625