EUCTR2019-000261-21-GB进行中（未招募）1 期
A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis - BALANCE - CF(TM) 1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 98
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
- •1. Male or female patients / 12 years of age or older at screening;
- •2. Documented diagnosis of cystic fibrosis including:
- •positive sweat chloride = 60 mEq/L, by pilocarpine iontophoresis or
- •a genotype with 2 identifiable mutations consistent with cystic fibrosis accompanied by one or more clinical features with cystic fibrosis phenotype;
- •3. FEV1 = 40% and = 90% of predicted values at screening and at predose at Visit 2 (randomisation).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 21
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 77
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Evidence of acute upper or lower respiratory tract infection within 4 weeks prior to randomisation based on investigator’s judgement;
- •2. Pulmonary exacerbation requiring use of i.v./oral/inhaled antibiotics or oral corticosteroids within 4 weeks prior to randomisation;
研究者
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