LBCTR2020011378已完成3 期
A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Existing Asthma Therapy in Patients With Uncontrolled Severe Asthma.
ovartis Pharmaceuticals0 个研究点目标入组 9 人开始时间: 2020年6月16日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
研究概览
简要总结
Please reference this link about study results
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 12 至 99（—）
- 性别
- All
入选标准
- •Written informed consent.
- •Male and female patients aged more than or equal 12 years.
- •A diagnosis of severe asthma, uncontrolled on GINA 4 over 5 asthma medication.
- •Evidence of airway reversibility or airway hyper- reactivity.
- •FEV1 less than or equal 80 percent of the predicted normal value for patients aged more than or equal 18 years; FEV1 of less than or equal 90 percent for patients aged 12 to less than 18 years
- •An ACQ score more than or equal 1.5
- •A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.
排除标准
- •Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.
- •Subjects who have participated in another trial of QAW039.
- •A QTcF (Fridericia) more than or equal 450 msec (male) or more than or equal 460 msec (female).
- •History of malignancy with the exception of local basal cell carcinoma of the skin.
- •Pregnant or nursing (lactating) women.
- •Serious co-morbidities.
- •Patients on more than 20 mg of simvastatin, more than 40 mg of atorvastatin, more than 40 mg of pravastatin, or more than 2 mg of pitavastatin.
研究者
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