Prevalence and Impact on Quality of Life of Airway Disease in Patients With Idiopathic Pulmonary Fibrosis
- Conditions
- Idiopathic Pulmonary FibrosisAirway Disease
- Registration Number
- NCT03215147
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
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.
- Detailed Description
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.
Unlike idiopathic pulmonary fibrosis, airway disease is a treatable, modifiable disease, so treatment of these diseases may improve QOL in IPF patients.
Therefore, this study's purpose is A. Identify the prevalence of airway disease in IPF patients B. Identify differences in QOL and symptoms according to presence of airway disease C. Identify the symptomatic improvement after active treatment for the airway diseases
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- IPF patients
- Patients on systemic steroid
- Patients with acute exacerbation within the last 6 months
- PFT+BDR, MBPT contra-indication
- SpO2 < 90%
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants who have asthma combined with idiopathic pulmonary fibrosis 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 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 Through study completion, an average of 2 year Confirmation of Eosinophilic bronchitis : pulmonary function test with bronchodilator response, induced sputum
- Secondary Outcome Measures
Name Time Method 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 Quality of life : COPD assessment test(CAT)
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 Quality of life : St George's Respiratory Questionnaire(SGRQ)
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 Symptom severity : mMRC
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 Symptom severity : EQ-5D-VAS
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 Symptom severity : 6 minute walking test(6MWT)
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 Symptom severity : Cough Quality-of-Life Questionnaire(CQLQ)
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 Quality of life : COPD assessment test(CAT)
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 Quality of life : St George's Respiratory Questionnaire(SGRQ)
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 Symptom severity : mMRC
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 Symptom severity : 6 minute walking test(6MWT)
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 Symptom severity : EQ-5D-VAS
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 Symptom severity : Cough Quality-of-Life Questionnaire(CQLQ)
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of