EUCTR2016-005230-30-IT进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects with Cystic Fibrosis (HOPE-1 STUDY: HYDRATION FOR OPTIMAL PULMONARY EFFECTIVENESS) - HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 91
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
- •- Ability to provide written, personally signed, and dated informed consent
- •- Ability to self-administer the investigational product
- •- Diagnosis of cystic fibrosis as determined by the 2008 Cystic Fibrosis Foundation Consensus Guidelines
- •- Percent predicted forced expiratory volume in 1 second (ppFEV1) between 40.0% and 80.0% for cohort 1 and between 50.0% and 80% for cohort 2
- •- Stable CF lung disease
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- BMI < 18 kg/m2
- •- Use of a Cystic fibrosis transmembrane conductance regulator (CFTR) corrector or potentiator during the study or within 60 days before screening
- •- The presence of significant unstable comorbidities within 28 days before screening
研究者
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