Interstitial Lung Disease Registry Construction

• Conditions: Interstitial Lung Disease

• Registration Number: NCT03238989
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is investigating the clinical course, treatment course, and prognosis of patients with interstitial lung disease.

Detailed Description

Interstitial lung disease refers to pulmonary disease that occurs in the interstitium of the lung.

It can be broadly classified into lung disease secondary to the cause of systemic disease or drug, and lung disease whose cause is unknown, and the latter is known as idiopathic interstitial pneumonia.

Idiopathic interstitial pneumonia is a lung disease showing various aspects of inflammatory response and fibrosis reaction, and the cause of the onset is not accurately known yet, also there is no effective treatment.

Idiopathic interstitial pneumonia, including idiopathic pulmonary fibrosis, progresses very slowly, but sometimes acute exacerbation without any obvious cause leads to death, rapidly.

Therefore, it is important to collect data prospectively for changes in clinical features, pulmonary function, imaging findings, and quality of life of these patients.

A prospective study of idiopathic interstitial pneumonia will provide important information on the clinical characteristics and admission history of patients with idiopathic interstitial pneumonia, and the idiopathic interstitial pneumonia registry system will serve as the basis for further prospective observational studies.

The aim of this study is to establish the registry of patients with interstitial lung disease and to prospectively review the clinical features and progression of the patients.

Study Timeline

• Study Start: 2014-01-05
• Study First Submitted: 2017-07-27
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-01
• Last Update Submitted: 2017-08-01
• Study First Posted: 2017-08-03
• Last Update Posted: 2017-08-03
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients older than 20 years diagnosed with interstitial lung disease

• Diagnostic criteria for interstitial lung disease. If one of the following is met:

  1. clinical suspicion of idiopathic pulmonary fibrosis (IPF); Characteristic chest CT findings with honeycomb cysts and fibrosis and reasonable clinical signs
  2. suspected interstitial pneumonia, or confirmed by biopsy with no evidence of infection : IPF, Non-specific interstitial pneumonia(NSIP), Cryptogenic organizing pneumonia(COP), unclassified fibrosis
  3. interstitial lung disease suspects with underlying rheumatic disease

Exclusion Criteria

• No specific criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
arterial blood gas analysis(ABGA)	at baseline	additionally tested at acute exacerbation
echocardiography	at baseline	additionally tested at acute exacerbation
St George's Respiratory Questionnaire(SGRQ)	at baseline, every 1 year through study completion for 10 years	monitoring changes in clinical symptoms
modified Medical Research Council (mMRC) dyspnea scale	at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years	monitoring changes in clinical symptoms
Borg dyspnea scale	at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years	monitoring changes in clinical symptoms
Hospital anxiety and depression score(HADS)	at baseline, every 1 year through study completion for 10 years	monitoring changes in clinical symptoms
chest X-ray	at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years	monitoring changes in chest radiography
Chest CT	at baseline, every 1 year through study completion for 10 years	monitoring changes in chest radiography
Paranasal sinus X-ray(PNS series)	at baseline	baseline PNS X-ray
Electrocardiogram(ECG)	at baseline	baseline ECG
Pulmonary function test with bronchodilator response test(PFT+BDR)	at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years	monitoring changes in lung function
Diffusing capacity of the lungs for carbon monoxide(DLCO)	at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years	monitoring changes in lung function
total lung capacity(TLC)	at baseline	monitoring changes in lung function
Bronchoscopic alveolar lavage(BAL)	at baseline	for diagnostic purposes if necessary
Video-assisted thoracoscopic surgery(VATS) lung biopsy	at baseline	for diagnostic purposes if necessary

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of