ACTRN12607000379415终止4 期
In bronchiectatic patients susceptible to airway narrowing after inhaling dry powder mannitol is a single dose of sodium cromoglycate or eformoterol more effective than placebo in preventing airway narrowing
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Subjects must: 1) Have given written informed consent to participate in this study, 2) Have symptomatic (i.e. daily production of sputum) non-cystic fibrosis (CF) bronchiectasis, confirmed by high resolution computed tomography (HRCT), 3) Be a non smoker, 5) Be able to perform reproducible spirometry, 4) Have an FEV1 1.2 Litres, 5) Be in a stable clinical condition at the time of, and for a period of 14 days prior to, recruitment into the study, 6) Have a positive response to inhaled mannitol, as measured by a fall in FEV1 of 15% after < 315mg of mannitol on Visit 1
排除标准
- •Subjects must not: 1) Have bronchiectasis as a consequence of cystic fibrosis or focal endobronchial lesion, 2) Be considered terminally ill” or listed for lung transplantation, 3) Have had a significant episode of haemoptysis (>60 mL) in the previous six months, 4) Have had an exacerbation for which they have been prescribed intravenous antibiotics in the 4 weeks prior to study entry, 5) Have a smoking history of >20 pack years or have smoked more than one cigarette a week within the previous three months, 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) Have active tuberculosis, 12) Have active malignancy including melanoma (other skin carcinomas and remissions exempted), 13) Be breast feeding or pregnant, or plan to become pregnant while in the study, 14) Be using an unreliable form of contraception (female subjects at risk of pregnancy only), 15) Be participating in another investigative drug study, parallel to, or within 4 weeks of study entry, 16) Have a known intolerance to mannitol or ß-agonists, 17) Have uncontrolled hypertension – systolic BP > 190 and/or diastolic BP > 100, 18) Have resting oximetry of less than 90%, 19) 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.
研究者
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