EUCTR2008-002740-42-FR进行中（未招募）1 期
ong Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 318
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 Wang32 <8 years and NHanes III33 >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).
研究者
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