EUCTR2019-004182-41-FR进行中(未招募)1 期
Chronic airway disease, mucus rheology and exacerbations: a randomized controlled trial of COPD patients (COPD-CARhE) - (COPD-CARhE)
niversity hospital of Montpellier0 个研究点目标入组 72 人开始时间: 2019年12月2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
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Between 40 and 85 years old
- •Signed informed consent form
- •Subjects must be able to attend all scheduled visits and comply with all testing procedures
- •Beneficiary of the French social security system
- •Man or woman with COPD for at least 1 year defined according to the GOLD criteria and validated by the clinical investigator
- •Optimal treatment according to GOLD recommendations Grade of severity C or D
- •? 1 exacerbation in the last 12 months
- •Spontaneous or induced sputum production
- •ECG: QTc <450 ms in man, QTc<470 ms in woman
- •Normal Audiogram
- •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 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Pregnancy or breastfeeding
- •Patients who are prisoners or other forms of judicial protection
- •Patients under any form of tutorship / curatorship
- •The patient participates in another interventional protocol, or did so in the month prior to inclusion
- •Received azithromycin in the previous 3 months
- •History of allergy or intolerance to macrolides / azithromycin
- •Concomitant medication incompatible with azithromycin
- •Other respiratory diseases or associated lung infections
- •History of severe hepatic impairment (a liver function test will be performed if clinical suspicion)
研究者
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