EUCTR2015-004143-39-DK进行中（未招募）1 期
A Phase 3 randomised, double-blind, controlled trial of inhaled 7%hypertonic saline versus0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6years of age inparallel with the North American SHIP clinical trial - Ship-CT study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Erasmus MC
- 入组人数
- 120
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
- •Diagnosis of CF as evidenced by one or more clinical features
- •consistent with the CF phenotype or positive CF newborn screen
- •AND one or more of the following criteria:
- •a) A documented sweat chloride = 60 mEq/L by quantitative
- •pilocarpine iontophoresis (QPIT)
- •b) A documented genotype with two disease-causing
- •mutations in the CFTR gene
- •2. Informed consent by parent or legal guardian
- •3. Age = 36 months and =72 months at screening visit
- •4. Ability to comply with medication use, study visits and study
- •procedures as judged by the site investigator
- •5. Ability to cooperate with chest CT at the enrolment visit as
- •determined by the lung function technician
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Acute intercurrent respiratory infection, defined as an increase in
- •cough, wheezing, or respiratory rate with onset within 3 weeks
- •preceding screening or enrolment visit
- •3. Acute wheezing at screening or enrolment visit
- •4. Oxygen saturation < 95% (<90% in centres located above 4000 feet
- •elevation) at screening or enrolment visit
- •5. Other major organ dysfunction, excluding pancreatic dysfunction
- •6. Physical findings that would compromise the safety of the
- •participant or the quality of the study data as determined by site
- •investigator
- •7. Investigational drug use within 30 days prior to screening or
- •enrolment visit
- •8. Treatment with inhaled HS at any concentration within 30 days prior
- •Chest CT within 8 months prior to screening or enrolment visit
- •9. Initiation (i.e. new prescription) of any inhaled hydrating agent such
- •as mannitol or mucolytic agents such as dornase alpha within 30
- •days prior to the screening or enrolment visit
- •10. Chronic lung disease not related to CF
- •11. Inability to tolerate first dose of study treatment at the enrolment
研究者
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