Prevalence and Impact on Quality of Life of Airway Disease in Patients With Idiopathic Pulmonary Fibrosis
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Number of participants who have asthma combined with idiopathic pulmonary fibrosis
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •IPF patients
Exclusion Criteria
- •Patients on systemic steroid
- •Patients with acute exacerbation within the last 6 months
- •PFT+BDR, MBPT contra-indication
- •SpO2 < 90%
Outcomes
Primary Outcomes
Number of participants who have asthma combined with idiopathic pulmonary fibrosis
Time Frame: 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
Time Frame: 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
Time Frame: Through study completion, an average of 2 year
Confirmation of Eosinophilic bronchitis : pulmonary function test with bronchodilator response, induced sputum
Secondary Outcomes
- 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)
Investigators
Sun Mi Choi
Assistant professor
Seoul National University Hospital