ISRCTN86496888已完成未知
Assessment of epithelial permeability in asthma through nuclear imaging: an observational trial
Southampton University Hospitals NHS Trust (UK)0 个研究点目标入组 40 人开始时间: 2009年7月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Subject must understand the procedures of the study and agree to participation in the study by providing written informed consent
- •2. Subject considered fit enough to undergo lung function testing including provocation tests
- •3. Either gender
- •4. Age 18 - 55 years at screening
- •Group specific:
- •1. Healthy controls:
- •1.1. Lifelong non-smoker
- •1.2. No history suggestive of airways disease
- •1.3. Normal spirometry, normal exhaled nitric oxide (NO), provocative concentration causing a 20% fall in forced expiratory volume in one second (FEV1) (PC20) (metacholine) greater than 8 mg/ml (non-cumulative)
- •1.4. No signs of concurrent respiratory infection at time of scanning or within previous 8 weeks
- •1.5. No significant cardiopulmonary/hepatic or renal co-morbidity
- •2. Smokers:
- •2.1. Daily smokers of tobacco cigarettes
- •2.2. Normal spirometry, normal exhaled NO, PC20 (metacholine) greater than 8 mg/ml (non-cumulative)
- •2.3. No signs of concurrent respiratory infection at time of scanning or within previous 8 weeks
- •3. Asthmatics - controlled:
- •3.1. Asthma defined as per BTS guidelines, on treatment with inhaled corticosteroids +/- long-acting beta-agonists
- •3.2. Lifelong non-smokers (never smoked)
- •3.3. Clinically stable with FEV1 greater than 70% post-bronchodilator use, with use of rescue bronchodilators less than 3 x week
- •3.4. No signs of concurrent respiratory infection at time of scanning or within previous 8 weeks
- •4. Asthmatics - uncontrolled:
- •4.1. Asthma defined as per BTS guidelines, on treatment with inhaled corticosteroids +/- long-acting beta-agonists
- •4.2. Lifelong non-smokers (never smoked)
- •4.3. Use of rescue bronchodilator greater than 3 times a week
- •4.4. No signs of concurrent respiratory infection at time of scanning or within previous 8 weeks
排除标准
- •1. Pregnancy (where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotrophin [hCG] laboratory test greater than 5 mIU/ml), an intention to become pregnant or breast-feeding (lactating)
- •2. Subjects with active lung disease other than asthma
- •3. Significant medical co-morbidity which in the view of the investigator could impact on the interpretation of results or participation in the trial
- •4. Active cancer or a history of cancer or radiotherapy
- •5. Current/previous users of recreational inhaled illicit drugs, e.g. cannabis, crack cocaine, etc.
- •6. Inability to lie flat for scan for 2 hours
- •7. Those who have participated in a clinical trial involving an investigational or marketed drug within 12 weeks of screening, or participated in any study involving radiation within 12 months of screening
- •8. Those in any situation which, in the opinion of the investigator, may interfere with optimal participation in the study
- •9. Those unable to optimally perform the breathing manoeuvres required for lung function testing, or deposition of the radio-labelled aerosol
- •10. Signs of concurrent respiratory tract infection on examination at the time of scanning or within previous 8 weeks (can be rescreened after 8 weeks if otherwise eligible)
研究者
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