EUCTR2011-004351-39-IT进行中（未招募）不适用
Phase II, randomized, double arm, multi-center study evaluating the efficacy and safety of azithromycin for the long term prophylactic treatment of COPD in primary antibody deficiency patients with clinical and spirometrically confirmed COPD suffering from repeated acute exacerbations
AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA0 个研究点开始时间: 2012年3月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •diagnosis of X-linked Agammaglobulinemia or Common Variable Immunodeficiency •male or female aged 12 to 74 years •clinical and spirometrically confirmed COPD •written informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 38
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •known allergic reaction to azithromycin • patients taking drugs that could adversely interact with macrolides • lymphoproliferative disease • Creatinine concentration >1.5 times the UNL • ASAT or ALAT concentration >2.5 times the UNL • HIV infection, acute hepatitis or clinically active chronic hepatitis • Pregnancy or breast feeding females planning to become pregnant during the course of the study • Any condition that is likely to interfere with the evaluation of the study drug or satisfactory conduct of the trial
研究者
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