NCT03238989

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2014

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

10 years

First QC Date

July 27, 2017

Last Update Submit

August 1, 2017

Conditions

Interstitial Lung Disease

Keywords

Interstitial lung disease

Outcome Measures

Primary Outcomes (15)

  • St George's Respiratory Questionnaire(SGRQ)

    monitoring changes in clinical symptoms

    at baseline, every 1 year through study completion for 10 years

  • modified Medical Research Council (mMRC) dyspnea scale

    monitoring changes in clinical symptoms

    at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years

  • Borg dyspnea scale

    monitoring changes in clinical symptoms

    at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years

  • Hospital anxiety and depression score(HADS)

    monitoring changes in clinical symptoms

    at baseline, every 1 year through study completion for 10 years

  • chest X-ray

    monitoring changes in chest radiography

    at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years

  • Chest CT

    monitoring changes in chest radiography

    at baseline, every 1 year through study completion for 10 years

  • Paranasal sinus X-ray(PNS series)

    baseline PNS X-ray

    at baseline

  • Electrocardiogram(ECG)

    baseline ECG

    at baseline

  • Pulmonary function test with bronchodilator response test(PFT+BDR)

    monitoring changes in lung function

    at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years

  • Diffusing capacity of the lungs for carbon monoxide(DLCO)

    monitoring changes in lung function

    at baseline, after 1 month, after 3 month, and then every 1 year through study completion for 10 years

  • total lung capacity(TLC)

    monitoring changes in lung function

    at baseline

  • Bronchoscopic alveolar lavage(BAL)

    for diagnostic purposes if necessary

    at baseline

  • Video-assisted thoracoscopic surgery(VATS) lung biopsy

    for diagnostic purposes if necessary

    at baseline

  • echocardiography

    additionally tested at acute exacerbation

    at baseline

  • arterial blood gas analysis(ABGA)

    additionally tested at acute exacerbation

    at baseline

Interventions

monitoring changes in clinical symptoms, pulmonary function, and chest radiographyOTHER

For patients with interstitial lung disease, the investigators regularly monitor changes in clinical symptoms, pulmonary function, and chest radiography after basic questionnaire on symptoms, lifestyle, depression, and quality of life.

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

outpatient, ward

You may qualify if:

  • Patients older than 20 years diagnosed with interstitial lung disease
  • Diagnostic criteria for interstitial lung disease. If one of the following is met:
  • clinical suspicion of idiopathic pulmonary fibrosis (IPF); Characteristic chest CT findings with honeycomb cysts and fibrosis and reasonable clinical signs
  • suspected interstitial pneumonia, or confirmed by biopsy with no evidence of infection : IPF, Non-specific interstitial pneumonia(NSIP), Cryptogenic organizing pneumonia(COP), unclassified fibrosis
  • interstitial lung disease suspects with underlying rheumatic disease

You may not qualify if:

  • No specific criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Central Study Contacts

Choi Sun Mi

CONTACT

02-2072-4915sunmich81@gmail.com

PARK HEEMOON

CONTACT

coramdeo33@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 27, 2017

First Posted

August 3, 2017

Study Start

January 5, 2014

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 3, 2017

Record last verified: 2017-08

Locations

KR(1)