NCT00381147已完成3 期
Phase III, Randomized, Double Blind Study of Low Dose Long Term Clarithromycin Versus Placebo in Treatment of Chronic Pulmonary Lesions Due to Sulfur Mustard
Baqiyatallah Medical Sciences University2 个研究点 分布在 2 个国家开始时间: 2006年9月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
We looked for the effectiveness of low-dose long-term prescription of clarithromycin in mustard-induced chronic pulmonary lesions, especially bronchiolitis obliterans
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •His/her own will to participate
- •Documented chemical exposure
- •Clinical, spirometric and radiological findings were compatible with BO on High Resolution Computed Tomography (HRCT)
排除标准
- •any drug reactions during the trial
- •history of sensitivity to macrolides
- •diarrhea, gray stool, jaundice, eosinophilia, acute cholestatic hepatitis, pruritis, dark urine, abdominal pain, osteomatosis, depression, taste change, behavioural changes, early fatigue, odynophagia, glossitis , dizziness
- •co-adminstration of: terfenadine, theophylline, carbamazepine, ergotamine, dihydroergotamine, warfarin, cisapride, digoxin, triazolam, phenytoin, steroids, any immunosuppressive, any systemic antibiotics
- •using drugs that he/she cannot discontinue
- •using drugs with potential interaction
- •subject will to exit from the trial
- •history of lobe resection of lung
- •history of exacerbation in the last month prior to the beginning of trial
- •continuous need to oxygen
- •use of corticosteroids in last week prior to the trial beginning
- •Radiographic evidence of pneumonia, active tuberculosis, lung carcinoma, or an infection that necessitated the use of an antibiotic
- •exacerbating of subjects
- •creatinine srum level more than normal
- •increasing ALT, AST levels
- •total bilirubin more twice than normal
- •subjects who did not use their drugs properly
研究者
研究点 (2)
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