Individualized Diagnosis and Treatment of Extraesophageal Reflux in Patients With Chronic Cough
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- EER severity and type and allergy
研究概览
简要总结
Chronic cough is a very unpleasant symptom, significantly reduces the patient's quality of life, and bothers the neighborhood. A very common cause or co-factor of chronic cough is extraesophageal reflux (EER).
The aim of the project is the precise diagnosis of EER in patients with chronic cough (in patients with a simultaneously diagnosed allergic cause and without it).
详细描述
Chronic cough is a very unpleasant symptom, significantly reduces the patient's quality of life, and bothers the neighborhood. A very common cause or co-factor of chronic cough is extraesophageal reflux (EER). Liquid reflux, or even just aerosol reflux, causes mucosal inflammation and sensitizes the mucous membrane of the airways, which is then sensitive to even slight noxa. The cough then further damages the mucosa, creating a vicious circle. EER can be the main cause of chronic cough, but also a worsening cofactor of cough in patients with other causes (allergic and non-allergic bronchial asthma, chronic rhinosinusitis, and others).
The aim of the project is the precise diagnosis of EER in patients with chronic cough (in patients with a simultaneously diagnosed allergic cause and without it). Accurate diagnosis and assessment of severity allow patients to be divided into 2 groups. The group with mild symptoms and the findings will be treated in the first phase with diet and lifestyle modifications. With a positive response to this "conservative" type of treatment, patients would not have to undergo a series of tests. Patients with severe problems and confirmed EER will be treated individually according to recommended measures.
Study protocol
- signing of Informed Consent
- anamnestic questionnaire (age, sex, weight, height, smoking, alcohol, reflux disease, treatment of allergic disease, pyrosis, treatment of reflux disease)
Allergology examination
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-80 years
- •patients with chronic cough (cough that lasts 3 months or longer)
- •consent with participation in the study
排除标准
- •patients using ACE inhibitors or Angiotensin II receptor blockers
- •patients with head and neck cancer
- •patients after radiotherapy in the head and neck area
- •patients with airway or lung cancer
- •patients with chronic lung disease except for bronchial asthma (COPD, interstitial lung disease, bronchiectasis, respiratory bronchiolitis)
- •patients with chronic rhinosinusitis
结局指标
主要结局
EER severity and type and allergy
时间窗: 6 months
Comparison of extraesophageal reflux severity and type in patients with chronic cough with or without concomitant allergic cause of cough. The number of EER events on impedance and improvement of RSA - Short version scale (Reflux Sign Assessment - Short version) will be observed and compared with improvement of objective measurements and clinical findings.
次要结局
- Asthma severity and control(6 months)
- Allergic diseases and chronic cough with concomitant extraesophageal reflux(6 months)
- Individual phenotypes of bronchial asthma in patients with EER(6 months)
- Diet and life-style modifications and asthma(6 months)