EUCTR2008-002644-42-GB进行中（未招募）不适用
A phase III multicenter, randomized, parallel, controlled, double blind study to investigate the safety and efficacy of inhaled mannitol over 12 months in the treatment of bronchiectasis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
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:
- •1. Have given written informed consent to participate in this study in accordance with local regulations
- •2. Have documented evidence of confirmed diagnosis of (non-CF) bronchiectasis by CT, HRCT or bronchogram
- •3. Be aged 18 – 80 years inclusive
- •4. Have FEV1 40 - 80% predicted* or =1.0L (according to NHANESIII predicted tables)
- •5. Documented history of at least 2 pulmonary exacerbations, each requiring antibiotic therapy, per year for the 2 years prior to study entry
- •6. Have chronic sputum production of >1 tablespoonful per day on the majority of days in the 3 months prior to visit 0
- •7. Have chronic chest congestion ( defined as chronic excessive accumulation of mucus in the lungs)
- •8. Be able to perform all the techniques necessary to measure lung function
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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. Have bronchiectasis as a consequence of cystic fibrosis or focal endobronchial lesion
- •3. Be considered terminally ill” or listed for transplantation
- •4. Be using hypertonic saline in the 4 weeks prior to commencing treatment
- •5. Have previously used inhaled mannitol for more than a day
- •6. Have had a significant episode of hemoptysis (>60 mL) in the previous 6 months
- •7. Have had antibiotics in the 4 weeks prior to V1 except chronic macrolide therapy
- •8. Have active signs and symptoms of asthma *
- •9. Have smoked within the last 3 months or ex-smokers with greater than 20 pack years (number of pack years = (number of cigarettes per day / 20) x number of years smoked, e.g., 20 cigarettes per day for 20 years, or 40 cigarettes per day for 10 years).
- •10. Have had a myocardial infarction in the three months prior to enrolment
- •11. Have had a cerebral vascular accident in the three months prior to enrolment
- •12. Have had major ocular surgery in the three months prior to enrolment
- •13. Have had major abdominal, chest or brain surgery in the three months prior to enrolment
- •14. Have a known cerebral, aortic or abdominal aneurysm
- •15. Have actively treated Mycobacterium tuberculosis
- •16. Have actively treated nontuberculous mycobacterial infection
- •17. Have end stage interstitial lung disease
- •18. Have active malignancy including melanoma (other skin carcinomas and remissions > 2 years exempted)
- •19. Be breast feeding or pregnant, or plan to become pregnant while in the study
- •20. Be using an unreliable form of contraception (female subjects at risk of pregnancy only)
- •21. Be participating in another investigational drug study, parallel to, or within 4 weeks of study entry
- •22. Have a known intolerance to mannitol or ß2-agonists
- •23. Have uncontrolled hypertension – e.g. for adults: systolic BP > 190 and or diastolic BP > 100
- •24. Subject has a condition or is 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
研究者
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