EUCTR2015-004143-39-ES进行中（未招募）1 期
A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel 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
- 116
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 feature 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 pilocarpineiontophoresis (QPIT) b) A documented genotype with two disease-causing mutations in the CFTR gene
- •Informed consent by parent or legal guardian
- •Age = 36 months and =72 months at Screening visit
- •Ability to comply with medication use, study visits and study procedures as judged by the site investigator
- •***Ability to execute a technician controlled or spirometer controlled chest CT scan***????
- •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
- •Chest CT within 8 months prior to the Screening visit
- •Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset within 3 weeks preceding Screening or Enrolment visit
- •Acute wheezing at Screening or Enrollment visit
- •Oxygen saturation < 95% (<90% at centres above 4000 feet elevation) at Screening or Enrollment visit
- •Other major organ dysfunction, excluding pancreatic dysfunction
- •Physical findings that would compromise the safety of the participant or the quality of the study data as determined by site investigator
- •Investigational drug use within 30 days prior to Screening or Enrolment visit
- •Treatment with inhaled hypertonic saline at any concentration within 30 days prior to Screening or Enrolment visit
- •Start of any additional inhaled saline solution at any concentration, or other hydrating agent such as mannitol or mucolytic drug such as dornase alpha within 30 days prior or following the Screening or Enrollment visit
- •Chronic lung disease not related to CF
- •Inability to tolerate first dose of study treatment at the Enrolment visit
研究者
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