EUCTR2013-005357-79-BG进行中（未招募）1 期
ong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects
Pharmaxis Limited0 个研究点目标入组 440 人开始时间: 2016年1月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 440
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
- •The subject must meet all of the following criteria:
- •1. Have given written informed consent to participate in this trial 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 at least 18 years old;
- •4. Have FEV1 > 40 % and < 90% predicted (using NHanes III [1]);
- •5. Be able to perform all the techniques necessary to measure lung function;
- •6.Be adherent with maintenance therapies (antibiotics and or rhDNase), if used, for at least 80% of the time in the two weeks prior to visit 1 and
- •7. If rhDNase and/or maintenance antibiotic are being used treatment must have been established at least 1 month prior to screening (Visit 0). The subject should remain on the rhDNase and / or maintenance antibiotics for the duration of the trial. The subject should not commence treatment with rhDNase or maintenance antibiotics during the trial.
- •Are the trial subjects under 18? no
- •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 418
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •The subject must NOT meet any of the following criteria:
- •1. Be investigators, site personnel directly affiliated with this trial, 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 maintenance nebulized hypertonic saline in the 2 weeks prior to visit 1;
- •5. Have had a significant episode of hemoptysis (> 60 mL) in the three months prior to Visit 0;
- •6. Have had a myocardial infarction in the three months prior to Visit 0;
- •7. Have had a cerebral vascular accident in the three months prior to Visit 0;
- •8. Have had major ocular surgery in the three months prior to Visit 0;
- •9. Have had major abdominal, chest or brain surgery in the three months prior to Visit 0;
- •10. Have a known cerebral, aortic or abdominal aneurysm;
- •11. Be breast feeding or pregnant, or plan to become pregnant while in the trial;
- •12. Be using an unreliable form of contraception (female subjects at risk of pregnancy only);
- •13. Be participating in another investigative drug trial, parallel to, or within 4 weeks of screening (Visit 0);
- •14. Have a known allergy to mannitol;
- •15. Be using non-selective oral beta blockers;
- •16. Have uncontrolled hypertension –i.e. 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 subject’s participation in the trial;or
- •18. Have a failed or incomplete MTT (as evaluated in Section 8.1.1.1).
研究者
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