Clinical Efficacy of Tiotripium in Patients With Airflow Obstruction Due to TB Destroyed Lung
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- St-George respiratory questionnaire(SGRQ)
研究概览
简要总结
The aim of this study to evaluate clinical efficacy of tiotropium in patients with airflow obstruction due to Tuberculosis (TB) destroyed lung.
详细描述
Tuberculosis can cause lung parenchymal destruction, volume loss, secondary bronchiectasis. Patients with TB destroyed lung complain chronic respiratory symptoms, such as chronic cough, sputum, dyspnea, exercise intolerance, and acute exacerbations. Some of them have chronic airflow obstructions on pulmonary function tests, similar to those of smokers.
Previous large randomized controlled trials, targeting patients with smoking related moderate to severe COPD,demonstrated that tiotropium improved quality of life and respiratory symptom with tolerable long-term safety. The investigators want to evaluate whether tiotropium can improve chronic respiratory symptom,an lung function in patients with COPD due to TB destroyed lung.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •previous pulmonary tuberculosis history
- •never smoker or light smoker (<10 pack-year)
- •destruction of lung parenchyme, lung volume loss,secondary bronchiectasis due to tuberculosis in chest radiographs or chest CT, confirmed by board-certificate radiologist
- •airflow obstruction confirmed by pulmonary function test, FEV1/FVC <70%
排除标准
- •patients do not agree with study enrollment
- •patients with active tuberculosis or current antituberculous medication
- •patients under chemotherapy or other immunosuppressant therapy such as glucocorticoid.
- •active infection such as pneumonia, tuberculosis
- •patients who are illiterate
- •patients with dementia
- •pregnant or to be pregnant
- •previous lung resection surgery history
结局指标
主要结局
St-George respiratory questionnaire(SGRQ)
时间窗: 6 months after initiation of tiotropium once-daily inhalation
次要结局
- lung function(6mo after initiation of tiotropium once-daily inhalation)
- cough VAS(6mo after initiation of tiotropium once-daily inhalation)
- adverse reaction of tiotropium(6 months after initiation of tiotropium once-daily inhalation)