EUCTR2008-008228-34-GB进行中（未招募）不适用
Determination of the pharmacokinetics of inhaled mannitol after single and multiple dosing in cystic fibrosis patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18
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
- •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 greater than or equal to 18 years for adults)
- •Have FEV1 > 30 % and < 90% predicted
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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
- •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
- •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.
研究者
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