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Clinical Trials/NCT03215147
NCT03215147
Unknown
Not Applicable

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

Seoul National University Hospital1 site in 1 country100 target enrollmentJune 7, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Idiopathic Pulmonary Fibrosis
Sponsor
Seoul National University Hospital
Enrollment
100
Locations
1
Primary Endpoint
Number of participants who have asthma combined with idiopathic pulmonary fibrosis
Last Updated
8 years ago

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. 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

Registry
clinicaltrials.gov
Start Date
June 7, 2017
End Date
February 28, 2020
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sun Mi Choi

Assistant professor

Seoul National University Hospital

Eligibility Criteria

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)

Study Sites (1)

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