Exploring the Relationship Between pH of Exhaled Breath Condensate and Disease Severity as Well as Prognosis of Bronchiectasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Exhaled breath condensate pH and the disease severity
研究概览
简要总结
The measurement of markers in the expired breath condensate has proven to be a useful method for assessing and monitoring airway inflammation. The aim of this study is to determine the amounts of pH in the expired breath condensate of patients with bronchiectasis, and the relationship between pH and the severity of bronchiectasis.
详细描述
The aim of this study is to determine the amounts of pH in the expired breath condensate of patients with bronchiectasis, and the relationship between pH and the severity of bronchiectasis. Further clarify the link between EBC pH and the risk of future acute exacerbations, mortality and lung function decline through a one-year follow-up. Hoping to explore new validated biomarkers of the disease severity and progression in bronchiectasis. During the observation, EBC pH and other valid indicators will be measured when patients were enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Each subject must meet all of the following criteria to be included in this study:
- •Willing to join in and sign the informed consent form.
- •Age>18 years, the diagnosis of bronchiectasis need reference to the definition of "non-cystic fibrosis bronchiectasis guideline" published by British Thoracic Society in 2010 or 2012 China bronchiectasis expert consensus, clinical symptoms of cough and expectoration, with or without intermittent hemoptysis, and chest CT showed bronchiectasis there.
- •All patients were clinically stable and had no evidence of infection or acute infective exacerbation (lower or upper respiratory tract) for at least 4 weeks before the study.
- •Patients with good compliance: the subject must be willing to follow the test plan requirements in the research center to complete all the assessment of the visit.
- •Control Subjects:
- •All normal subjects had a negative history of allergy (negative skin prick tests to common allergens);
- •Normal lung function, and normal bronchial reactivity.
- •No history of any lung disease (except for the history of pneumonia in the past time and small pulmonary nodules).
排除标准
- •Subjects who meet any of the following criteria should be excluded from this study:
- •Patients with a history of other respiratory diseases (cystic fibrosis, allergic bronchopulmonary aspergillosis, asthma, 1-antitrypsin deficiency, pulmonary tuberculosis, COPD, lung cancer, interstitial lung disease)and atopic diseases were excluded；
- •Serious comorbidities (chronic renal failure, hepatic disease, etc.) ;
- •Patients were on inhaled or oral mucolytics, or were receiving oxygen therapy or long-term oral antibiotics；
- •Poor compliance or cannot cooperate judged by doctors;
- •Participated in other clinical trials for nearly three months;
结局指标
主要结局
Exhaled breath condensate pH and the disease severity
时间窗: One year
The Relationship between pH of exhaled breath condensate and disease severity of Bronchiectasis
次要结局
- Sputum bacteriological evaluation(One year)
- Blood gases parameters （PaO2, SaO2, PaCO2, pH）(30 days)
- SGRQ scores(30 days)
- Time to first exacerbation during the one-year follow up(30 days)
- Frequency of acute exacerbation during one year(30 days)
- The number of hospitalizations for exacerbation(30 days)
- Sputum and peripheral blood inflammatory index (including IL-6, IL-8, IL-1β, TNF-a)(One year)
- BSI scores(30 days)
- Lung function (FEV1 %, FVC %, FEV1/FVC %)(One year)
- Chest high-resolution computed tomography (CT)(One year)
- Sputum neutrophil cell(One year)
研究者
Jin-Fu Xu
Director, Head of respiratory medicine
Shanghai Pulmonary Hospital, Shanghai, China