The Value of FeNO, Blood Eosinophils and TIgE in Predicting the Response to Corticosteroid in Patients With Chronic Cough
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 502
- 试验地点
- 1
- 主要终点
- Cough VAS change from baseline to the 4th week
研究概览
简要总结
To investigate the value of blood eosinophils, FeNO and total IgE in predicting the response to inhaled corticosteroid in patients with chronic cough.
详细描述
Chronic cough is a frequent complaint in respiratory specialists clinic. CVA, UACS, EB, GERC and AC are common causes of chronic cough, among whom, CVA, EB and AC can be classified as corticosteroid responsive cough.
To recognize the eosinophilic airway inflammation and assess the response of inhaled corticosteroid, induced sputum analysis is the most widely used examination but not all the subjects can provide an suitable sample of sputum for measurements and it's time-consuming.
Recently, blood eosinophils, FeNO and total IgE were detected to be biomarkers of eosinophilic airway inflammation for asthmatics. However, whether can they predict the response to corticosteroid in chronic cough remains uncertain.
The present prospective, multi-center, randomized placebo-controlled study aims to explore the value of blood eosinophils, FeNO and total IgE in predicting the response to inhaled corticosteroid in patients with chronic cough.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •Age: 18-70 years;
- •Coughing lasting ≥ 8 weeks；
- •No abnormality in chest imaging in the past 3 months (or there is abnormality but the investigator judges it not the cause of chronic cough)；
- •FEV1% pred>70%；FEV1/FVC>70%；
- •VAS≥30 in the past 48 hours;
- •Non-smokers or patients smoked less than 10 pack-years;
- •Candidates voluntarily participate in and abide by the relevant regulations of the study, can cooperate with corresponding inspections, follow the follow-up plan, and voluntarily sign written informed consent.
排除标准
- •Patients received inhaled or oral corticosteroids or leukotriene receptor antagonist in previous 4 weeks;
- •Patients with history of upper respiratory tract infection in the past 8 weeks;
- •Patients taking angiotensin-converting enzyme inhibitors in previous 8 weeks;
- •Female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study;
- •Combined with a definite history of pulmonary diseases such as bronchiectasis, pulmonary interstitial disease, and pulmonary hypertension. Combined with other serious diseases (such as cardiovascular system diseases, metabolic system diseases, immune system diseases, nervous system diseases, etc.) that may affect the normal process of this study;
- •Participating in other drug clinical trial projects.
研究组 & 干预措施
Foster treatment group
Participant inhales Foster (Inhaled Beclometasone Dipropionate and Formoterol Inhalation Aerosol) 1 puff bid for 4 weeks.
干预措施: Beclometasone Dipropionate and Formoterol Inhalation Aerosol (Drug)
Placebo controlled group
Participant inhales matched placebo 1 puff bid for 4 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Cough VAS change from baseline to the 4th week
时间窗: the 4th week
the percentage change in cough VAS score from baseline at week 4, calculated as (VAS baseline-VAS week 4) / VAS baseline×100%.
次要结局
- LCQ change from baseline to the 4th week(the 4th week)
- Cough VAS change from baseline to the 4th week(the 4th week)
- CET change from baseline at week 4(the 4th week)
- patient-reported global treatment response(the 4th week)
研究者
Kefang Lai
professor
The First Affiliated Hospital of Guangzhou Medical University