Prevalence and Impact on Quality of Life of Airway Disease in Patients With Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants who have asthma combined with idiopathic pulmonary fibrosis
研究概览
简要总结
The investigators assess the prevalence of airway disease associated with idiopathic pulmonary fibrosis in Korea, and evaluate the effect of these airway diseases on the symptoms and quality of life of patients with idiopathic pulmonary fibrosis.
详细描述
Idiopathic pulmonary fibrosis (IPF) is defined as a specific form of chronic, progressive fibrosing interstitial pneumonia of unknown cause, occurring primarily in older adults, and limited to the lungs. It is characterized by progressive worsening of dyspnea and lung function and is associated with a poor prognosis.
The main symptoms of patients with IPF are dyspnea on exertion and a persistent dry cough or mildly productive cough.
In many IPF patients, cough is often the first symptom, preceding dyspnea on exertion sometimes by years. It affects upwards of 70-85% of patients with IPF.
Chronic obstructive pulmonary disease (prevalence rate 4-18%) and asthma (prevalence rate 5.9-9.9%) are the airway disease whose main symptoms are also dyspnea and cough.
To date, the effect of airway disease has not been well studied in patients with idiopathic pulmonary fibrosis, and the prevalence is unknown in Korea.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IPF patients
排除标准
- •Patients on systemic steroid
- •Patients with acute exacerbation within the last 6 months
- •PFT+BDR, MBPT contra-indication
- •SpO2 < 90%
结局指标
主要结局
Number of participants who have asthma combined with idiopathic pulmonary fibrosis
时间窗: Through study completion, an average of 2 year
Confirmation of asthma : pulmonary function test with bronchodilator response or Methacholine provocation test
Number of participants who have COPD combined with idiopathic pulmonary fibrosis
时间窗: Through study completion, an average of 2 year
Confirmation of COPD : pulmonary function test with bronchodilator response
Number of participants who have Eosinophilic bronchitis combined with idiopathic pulmonary fibrosis
时间窗: Through study completion, an average of 2 year
Confirmation of Eosinophilic bronchitis : pulmonary function test with bronchodilator response, induced sputum
次要结局
- The difference of CAT scores between patients with airway disease and those without airway disease.(baseline and after treating the airway disease for 6~8 weeks)
- The difference of SGRQ scores to assess quality of life between patients with airway disease and those without airway disease.(baseline and after treating the airway disease for 6~8 weeks)
- The difference of mMRC scores to assess symptom severity between patients with airway disease and those without airway disease.(baseline and after treating the airway disease for 6~8 weeks)
- The difference of EQ-5D-VAS scores to assess symptom severity between patients with airway disease and those without airway disease.(baseline and after treating the airway disease for 6~8 weeks)
- The difference of distance of 6MWT to assess symptom severity between patients with airway disease and those without airway disease.(baseline and after treating the airway disease for 6~8 weeks)
- The difference of CQLQ scores to assess symptom severity between patients with airway disease and those without airway disease.(baseline and after treating the airway disease for 6~8 weeks)
- Checking the improvement of CAT score to assess the quality of life between patients with airway disease and those without airway disease(After treating the airway disease for 6~8 weeks)
- Checking the improvement of SGRQ score to assess the quality of life between patients with airway disease and those without airway disease(After treating the airway disease for 6~8 weeks)
- Checking the improvement of mMRC scores to assess symptom severity between patients with airway disease and those without airway disease(After treating the airway disease for 6~8 weeks)
- Checking the improvement of distance of 6MWT to assess symptom severity between patients with airway disease and those without airway disease(After treating the airway disease for 6~8 weeks)
- Checking the improvement of EQ-5D-VAS score to assess symptom severity between patients with airway disease and those without airway disease(After treating the airway disease for 6~8 weeks)
- Checking the improvement of CQLQ to assess symptom severity between patients with airway disease and those without airway disease(After treating the airway disease for 6~8 weeks)
研究者
Sun Mi Choi
Assistant professor
Seoul National University Hospital