EUCTR2008-002740-42-NL进行中（未招募）不适用
ong Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •Subjects may be included in the study if all of the following criteria are met. The subject must:
- •1. Have given written informed consent to participate in this study in accordance with local regulations.
- •2. Have a confirmed diagnosis of cystic fibrosis (positive sweat chloride value = 60 mEq/L) and/or genotype with two identifiable mutations consistent with CF, accompanied by one or more clinical features consistent with the CF phenotype).
- •3. Be aged = 6 years old.
- •4. Have FEV1 greater than or equal to 40 % and less than 90% predicted (using Wang < 8 years and NHanes III = 8years).
- •5. Be able to perform all the techniques necessary to measure lung function
- •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
- •Subjects are excluded from participating in this study if one or more of the following criteria are met. The subject must NOT:
- •1. 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.
- •2. Be considered terminally ill” or eligible for lung transplantation.
- •3. Have had a lung transplant.
- •4. Be using nebulized hypertonic saline in the 4 weeks prior to visit 1.
- •5. Have had a significant episode of hemoptysis (>60 mL) in the three months prior to enrolment.
- •6. Have had a myocardial infarction in the three months prior to enrolment.
- •7. Have had a cerebral vascular accident in the three months prior to enrolment.
- •8. Have had major ocular surgery in the three months prior to enrolment.
- •9. Have had major abdominal, chest or brain surgery in the three months prior to enrolment.
- •10. Have a known cerebral, aortic or abdominal aneurysm.
- •11. Be breast feeding or pregnant, or plan to become pregnant while in the study.
- •12. Be using an unreliable form of contraception (female subjects at risk of pregnancy only). 13. Be participating in another investigative drug study, parallel to, or within 4 weeks of visit 0. 14. Have a known allergy to mannitol.
- •15. Be using beta blockers.
- •16. Have uncontrolled hypertension –e.g. for adults: systolic BP > 190 and / or diastolic BP > 100.
- •17. 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.
- •18. Be ‘MTT positive or incomplete’. (As evaluated in section 3.3.8.5 of the protocol).
研究者
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