NL-OMON55417招募中4 期
Anti-inflammatory effects of tiotropium in patients with stable COPD-A randomized controlled double-blind study - ANTIOFLAM study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Men or women, age >= 40 years
- •post-bronchodilator FEV1 >= 0.8 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 <
排除标准
- •Treatment with long-acting anticholinerigcs <4 weeks before the start of the
- •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.
研究者
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