EUCTR2013-002938-20-GB进行中（未招募）1 期
An open label trial of azithromycin in chronic productive cough - An open label trial of azithromycin in chronic productive cough
niversity of Nottingham0 个研究点目标入组 50 人开始时间: 2013年9月11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
- 50
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
- •Selection criteria for patients with chronic productive cough:
- •- Age 18 or above (no upper age limit)
- •- Male or female
- •- Non-smokers for 10 years and <20 pack year equivalents in total
- •- Persistent productive cough for > 3 months in duration
- •- Use of effective contraception:
- •Acceptable contraceptive methods include: established use of oral, injected or implanted hormonal methods; placement of an intrauterine device (IUD) or intrauterine system (IUS); condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide; true abstinence (when this is in line with the preferred and usual lifestyle of the participant); or vasectomised partner.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 42
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •Exclusion criteria for patients with chronic productive cough:
- •- History of obvious inhaled irritant exposure
- •- Evidence of primary or secondary immunodeficiency.
- •- Clinically important bronchiectasis on HRCT scan
- •- Prolonged QT interval on baseline or 1 month ECG or significant cardiac pathology prior to commencing azithromycin
- •- Pregnancy or intent to become pregnant during course of study
- •- Contra-indication to bronchoscopy (British Thoracic Society Guidelines)
- •- Abnormal LFT’s (greater than 2x upper limit of normal)
研究者
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