ACTRN12608000348358已完成未知
The effect of continuous positive airway pressure treatment compared with usual therapy on markers of systemic inflammation, pulmonary function and respiratory-related quality of life in patients with combined chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA), a parallel group randomized trial.
HMRC Centre for Clinical Research Excellence in respiratory and sleep0 个研究点目标入组 40 人开始时间: 2008年7月23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
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Age >= 18 years
- •2. GOLD Stage III or IV (severe COPD): post-bronchodilator forced expiratory volume in 1 second/forced vital (FEV1/FVC) < 0.70, FEV1 <50% predicted.
- •3. An established clinical history of COPD
- •4. Ex-smokers with a smoking history of at least 10 pack-years. Ex-smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
- •5. Moderate to severe Obstructive Sleep Apnoea (Apnoea Hypopnea Index >= 15)
排除标准
- •A subject will not be eligible for inclusion in this study if any of
- •the following criteria apply:
- •-Subjects who have a moderate exacerbation (that required systemic corticosteroid therapy or antibiotics) of COPD in the previous month or a severe exacerbation (that required hospitalization) in the 3 months prior to baseline visit.
- •-Current respiratory disorders other than COPD and asthma (e.g., lung cancer, sarcoidosis, tuberculosis, lung fibrosis, bronchiectasis)
- •-Had lung-volume reduction surgery and/or a lung transplant
- •-Requirement for nocturnal non-invasive ventilation or long term oxygen therapy (defined as oxygen therapy prescribed for 12 hours or more per day) at start of study
- •-Receiving long-term oral corticosteroid therapy (defined as continuous use for greater than 6 weeks. Courses of oral corticosteroids separated by a period of less than 7 days will be considered as continuous use).
- •- Severe OSA (minimum oxygen saturation < 65% or Respiratory Disturbance Index (RDI) > 80) requiring immediate treatment due to severity or increased associated risk (eg Transport worker
- •-Current treatment with CPAP (defined as CPAP usage within 3 months of baseline visit).
- •-Unwilling to use CPAP therapy.
- •-Serious, uncontrolled non-respiratory disease (including serious psychological disorders) likely to interfere with the study and/or likely to cause death within the 6-month study duration.
- •-Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
- •-Participation in any other interventional research study in the last 4 weeks before baseline visit.
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