Anti-inflammatory effects of tiotropium in patients with stable COPD - ANTIOFLAM

niversity Medical Center Groningen0 个研究点目标入组 50 人开始时间: 2018年11月1日最近更新: 2019年2月28日

试验速览

暂无简介。

•Men or women, age >= 40 years
•post-bronchodilator FEV1 >= 1.5 Litres
•smoking history of > 10 pack years.
•Being in a stable phase of COPD, as judged by the investigator. No courses of systemic steroids last 4 weeks
•Post-bronchodilator FEV1 / FVC ratio < 70% and post-bronchodilator FEV1 < 80%pred
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•Treatment with long-acting anticholinerigcs <4 weeks before the start of the study.
•Treatment with corticosteroids <4 weeks before the start of the study.
•Concomitant diagnosis of asthma.
•Females of childbearing potential without an efficient contraception unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH >40 mIU/mL or the use of one or more of the following acceptable methods of contraception:
•a) Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy).
•b) Hormonal contraception (implantable, patch, oral, injectable).
•c) Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository.
•d) Continuous abstinence.

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