NCT00792714已完成1 期
Determination of the Pharmacokinetics of Inhaled Mannitol After Single and Multiple Dosing in Cystic Fibrosis Patients
Syntara8 个研究点 分布在 2 个国家目标入组 18 人开始时间: 2008年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 8
- 主要终点
- The general objective of the study is to estimate the systemic pharmacokinetics of mannitol after single and multiple dosing of IDPM 400 mg to adult and paediatric cystic fibrosis patients.
研究概览
简要总结
The general objective of the study is to estimate the systemic pharmacokinetics of mannitol after single and multiple dosing of IDPM 400 mg to adult and paediatric cystic fibrosis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have given written informed consent to participate in this study in accordance with local regulations
- •Have a confirmed diagnosis of cystic fibrosis (sweat test and/or genotype)
- •Be aged >6 years (6-11 for paediatrics, 12-17 for adolescents and 18 years for adults)
- •Have FEV1 > 30 % and < 90% predicted
排除标准
- •Be investigators, site personnel directly affiliated with this study, or their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.
- •Be considered "terminally ill" or listed for lung transplantation
- •Have had a lung transplant
- •Be using nebulised hypertonic saline
- •Have had a significant episode of haemoptysis (> 60 mL) in the three months prior to enrolment
- •Have had a myocardial infarction in the three months prior to enrolment
- •Have had a cerebral vascular accident in the three months prior to enrolment
- •Have had major ocular surgery in the three months prior to enrolment
- •Have had major abdominal, chest or brain surgery in the three months prior to enrolment
- •Have a known cerebral, aortic or abdominal aneurysm
- •Be breast feeding or pregnant, or plan to become pregnant while in the study
- •Be using an unreliable form of contraception (female patients at risk of pregnancy only)
- •Be participating in another investigative drug study, parallel to, or within 4 weeks of study entry (except inhaled mannitol)
- •Not able to maintain a mannitol free diet from Day -2 until Day 8 of the treatment phase.
- •Have a known allergy to mannitol
- •Be using beta blockers
- •Have uncontrolled hypertension - systolic blood pressure > 190 and / or diastolic blood pressure > 100
- •Have a condition or be in a situation which in the Investigator's opinion may put the subject at significant risk, may confound results or may interfere significantly with the patient's participation in the study
- •Be MTT positive.
结局指标
主要结局
The general objective of the study is to estimate the systemic pharmacokinetics of mannitol after single and multiple dosing of IDPM 400 mg to adult and paediatric cystic fibrosis patients.
时间窗: 8 days
次要结局
未报告次要终点
研究者
研究点 (8)
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