EUCTR2008-005909-19-GB进行中（未招募）1 期
Does extra fine HFA-BDP suppress small airways inflammation in COPD? - PAW002
The University of Dundee0 个研究点目标入组 24 人开始时间: 2009年1月7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
- 24
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
- •1) Male or female >40 years old.
- •2) Post bronchodilator FEV1/FVC ratio of <0.7 and FEV1<80% predicted
- •3) Smoking history of =15 pack years
- •4) Small airways inflammation, characterised by elevated CANO (>3ppb).
- •5) Ability to comply with the requirements of the protocol.
- •6) Ability to give informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Oral steroid use or exacerbation within 6 weeks. Greater than 2 exacerbations requiring treatment in the previous 6 months.
- •2) Requirement for domiciliary oxygen.
- •3) Diagnosis of asthma.
- •4) Significant concomitant respiratory disease including bronchiectasis, ABPA, cystic fibrosis or cor pulmonale.
- •5) Any other clinically significant medical condition that may either endanger the health or safety of the participant, or jeopardise the protocol.
- •6) Any significantly abnormal laboratory result as deemed by the investigators.
- •Use of oral corticosteroids within the last 2 months.
- •7) Pregnancy, planned pregnancy or lactation.
- •8) Known or suspected contra-indication to any of the IMPs.
- •9) Concomitant use of medicines (prescribed, over-the counter or herbal) that may interfere with the trial.
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