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临床试验/EUCTR2019-004182-41-FR
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

发起方
niversity hospital of Montpellier

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