Measurement of Exhaled NO and Bronchial Provocation Test With Mannitol as a Predictor of Response to Inhaled Corticosteroids in Chronic Cough
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The intensity of coughing on a 10-cm visual scale
研究概览
简要总结
Chronic cough is defined by its persistence beyond 8 weeks. Many conditions can explain the existence of a bronchial inflammation. In the management of chronic cough, the search for bronchial hyperreactivity (HRB) is recommended. The treatment relies primarily on the prescription of inhaled corticosteroids. It has been shown recently that the existence of an HRB with Methacholine (bronchial provocation test used in routine) does predict the effectiveness of inhaled corticosteroid treatment in no more than 50% of cases.
It is now possible to assess the bronchial inflammation by rapid, non-invasive and reproducible tests such that the fraction of exhaled nitric oxide (FeNO) and bronchial provocation test with mannitol. In a retrospective study, it was shown that an increased value of FeNO (cut-off > 35 ppb) predicts a positive response to treatment with a sensitivity of 90% and a specificity of 80%.
详细描述
The purpose of this study is to show that the use of the prospective value of exhaled NO can predict response to treatment with inhaled corticosteroids in adult with chronic cough. In addition we will assess the interest of the prognosis of bronchial provocation test with mannitol in this indication.
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
- •Chronic Cough during 2 months
- •Social Security regimen affiliated
- •Consent form signed
排除标准
- •Smoking active
- •Treatment with angiotensin converting enzyme inhibitor
- •Clinical signs of obvious gastroesophageal reflux
- •Clinical rhinosinusitis
- •Recent respiratory infection (< 1 month)
- •Corticosteroid Treatment(oral or inhaled) within 2 weeks
- •VEMS < 1 L or < 80% of the theoretical value
- •Existence of an obstructive ventilatory disorder defined as a report (FEV/FVC) < 90% of the theoretical value
结局指标
主要结局
The intensity of coughing on a 10-cm visual scale
时间窗: 6 weeks after treatment with inhaled corticosteroids
次要结局
- Sensitivity, specificity, positive predictive value and negative predictive value of the threshold value of 35 ppb FeNo to the clinical response seen as positive if the EVA reduces cough of at least 2 cm(6 weeks after treatment with inhaled corticosteroids)
- Sensitivity, specificity, positive predictive value and negative predictive value of response to bronchial provocation test with mannitol on the clinical response seen as positive if the EVA reduces cough of at least 2 cm(6 weeks after treatment with inhaled corticosteroids)
- Correlation between the value of FeNo and dose of mannitol causing a fall of 15% of maximum volume expired second (PD15)(6 weeks after treatment with inhaled corticosteroids)
- Score quality of life of the Leicester Cough Questionnaire(6 weeks after treatment with inhaled corticosteroids)