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临床试验/NCT03215147
NCT03215147Unknown不适用

Prevalence and Impact on Quality of Life of Airway Disease in Patients With Idiopathic Pulmonary Fibrosis

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年6月7日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sun Mi Choi

Assistant professor

Seoul National University Hospital

研究点 (1)

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