EUCTR2015-003537-99-Outside-EU/EEA进行中（未招募）1 期
A PHASE IV MULTICENTER, RANDOMIZED, OPEN LABEL, TWO-PERIOD CROSSOVER STUDY IN PATIENTS WITH CYSTIC FIBROSIS TO EVALUATE THE COMPARABLE EFFICACY AND SAFETY OF PULMOZYME® DELIVERED BY THE ERAPID™ NEBULIZER SYSTEM
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •- Male and female patients, >/= 6 years of age
- •- Confirmed diagnosis of cystic fibrosis (CF)
- •- Receiving Pulmozyme once daily chronically for treatment of CF for at least 6 months prior to screening
- •- Percent predicted FEV1 >/= 40% at screening based on the Wang (males < 18 years, females < 16 years) or Hankinson (males >/= 18 years, females >/= 16 years) standardized equations
- •- Able to reproducibly perform spirometry testing and comply with study assessments
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- An acute respiratory infection or pulmonary exacerbation within 4 weeks prior to randomization
- •- Initiation of any new chronic therapy (e.g. inhaled corticosteroids, inhaled oral antibiotics, high-dose ibuprofen, hypertonic saline, ivacaftor) for respiratory disease within 4 weeks prior to randomization
- •- Changes in chest physiotherapy schedule within 4 weeks prior to randomization
- •- Hospitalization within 4 weeks prior to randomization
- •- Planned hospitalization during the 6-week study
- •- History of organ transplantation
- •- Participation in an investigational drug or device study within 30 day prior to screening
研究者
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