The CPASMA Trial: Is There an Improvement in Asthma in Patients With Both Asthma and Obstructive Sleep Apnoea Syndrome (OSAS) Treated With Continuous Positive Airway Pressure (CPAP) After Six Months?
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 10
- 主要终点
- Asthma control questionnaire
研究概览
简要总结
The CPASMA trial is a descriptive, prospective, multicentre clinical trial, with a before/after Continuous Positive Airway Pressure (CPAP) assessment in participating patients. It aims to answer the following question: Is there an improvement in asthma in those patients with both asthma and obstructive sleep apnoea syndrome (OSAS) treated with CPAP after six months?. It is hypothesized that treatment of OSAS with CPAP in patients with both OSAS and asthma concommitantly, may have a beneficial effect also on asthma outcomes. This clinical effect in asthma could be assessed objectively by applying validated questionnaires for quality of life and asthma control.
详细描述
Full protocol in Spanish, available upon request
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18 to 70 yrs.) with asthma who require treatment with CPAP because of OSAS (RDI> = 20 events per hour)
排除标准
- •unstable or severe comorbidity,
- •patients in treatment with drugs that interfere with the clinical course of asthma and/or OSAS,
- •cognitive/psychiatric disorders that preclude patient participation/cooperation,
- •COPD or other lung disease accompanied by chronic airflow limitation, and
- •any clinical condition considered severe enough by the investigators to preclude all the diagnostic and therapeutic procedures outlined in this protocol.
结局指标
主要结局
Asthma control questionnaire
时间窗: 6 months
Changes in clinical and functional variables and in the asthma control questionnaire (ACQ) in the period prior to start the CPAP treatment and after a 6-months follow-up period
次要结局
未报告次要终点
研究者
Dr. Joan B Soriano
Programme Director
Cimera