Prevalence of Hyperventilation Syndrome in Difficult Asthmatics Uncontrolled Despite a Daily Maximal Doses of Inhaled Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 2
- 主要终点
- Diagnostic of the hyperventilation syndrome
研究概览
简要总结
Most of asthmatics patients remain uncontrolled despite an inhaled steroids treatment. Chronic hyperventilation syndrome (also called Idiopathic Hyperventilation) occurs in 20 to 40% of asthmatic patients. The purpose of the study is to assess the prevalence of chronic hyperventilation syndrome in a specific population of difficult-to-treat asthmatics patients, those who receive daily high doses of inhaled steroids (≥ 1000 µg of fluticasone with an additional treatment by a long-acting beta 2-agonist (LABA) and who remain uncontrolled (Asthma control test (ACT) < 18). We plan to realize a systematic assessment of the diagnosis of chronic hyperventilation syndrome with the Nijmegen questionnaire, blood gases at rest, hyperventilation testing and Cardiopulmonary Exercise Testing(CPET). We also will collect demographic information as well as information about asthma history, asthma control and treatment.
详细描述
There is only one visit. During this visit, each patient will complete self-questionnaires like Nijmegen, Hospital Anxiety and Depression Scale(HAD), Short-Form 36(SF36), and Asthma Quality of Life Questionnaire (AQLQ), The participants will have baseline spirometry and fractional exhaled nitric oxide measured at expiratory flow of 50 mL/s (FENO50), blood gases at rest, an hyperventilation challenge and Cardiopulmonary Exercise Testing(CPET) to determine accurately the presence or not of chronic hyperventilation syndrome. The diagnosis is confirmed by two positive tests (Nijmegen, Hyperventilation challenge and blood gases) and the final decision of a medical committee. The first step is to determine the prevalence oh this syndrome in this specific population. The second step is to assess the sensitivity, the specificity, the false positive rate and the false negative rate of the different parameters measured during the tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women,
- •aged more than 18,
- •non smokers for two years or longer, less than 10 pack/years smoking history,
- •physician-diagnosed asthma,
- •uncontrolled asthma with Asthma control test (ACT) < 18,
- •historical of FEV1 reversibility,
- •daily inhaled steroids treatment by at least 2000microg eq beclomethasone,
- •Forced expiratory volume in 1 second (FEV1) > 50% predicted value
排除标准
- •other chronic pulmonary disease,
- •vocal cord dysfunction,
- •pregnancy,
- •Participation in another interventional research trial,
- •unable to provide consent,
- •asthma exacerbation within the last 4 weeks
研究组 & 干预措施
Severe uncontrolled asthma
Asthmatics patients with uncontrolled symptoms despite a daily treatment by high doses of inhaled steroids and LABA. Diagnostic of chronic hyperventilation syndrome.
干预措施: Diagnostic of chronic hyperventilation syndrome (Other)
结局指标
主要结局
Diagnostic of the hyperventilation syndrome
时间窗: Up to 4 hours
value of Nijmegen questionnaire, of blood gases at rest, of hyperventilation testing and of CPET
次要结局
- Assess the diagnosis value of the nijmegen questionnaire.(Up to 4 hours)
- Assess the diagnosis value of the blod gases at rest.(up to 4 hours)
- Assess the diagnosis value of the hyperventilation challenge.(Up to 4 hours)
- Assess the diagnosis value of the CPET.(Up to 4 hours)