NCT03215147

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.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Typical duration 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

June 7, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

July 12, 2017

Status Verified

July 1, 2017

Enrollment Period

2.7 years

First QC Date

June 18, 2017

Last Update Submit

July 9, 2017

Conditions

Idiopathic Pulmonary FibrosisAirway Disease

Keywords

Idiopathic Pulmonary FibrosisAirway Disease

Outcome Measures

Primary Outcomes (3)

  • Number of participants who have asthma combined with idiopathic pulmonary fibrosis

    Confirmation of asthma : pulmonary function test with bronchodilator response or Methacholine provocation test

    Through study completion, an average of 2 year

  • Number of participants who have COPD combined with idiopathic pulmonary fibrosis

    Confirmation of COPD : pulmonary function test with bronchodilator response

    Through study completion, an average of 2 year

  • Number of participants who have Eosinophilic bronchitis combined with idiopathic pulmonary fibrosis

    Confirmation of Eosinophilic bronchitis : pulmonary function test with bronchodilator response, induced sputum

    Through study completion, an average of 2 year

Secondary Outcomes (12)

  • 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 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 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

  • +7 more secondary outcomes

Interventions

Confirmation of Airway Disease combined with IPFDIAGNOSTIC_TEST

To confirm the airway disease combined with IPF, PFT+BDR+DLCO, MBPT, Induced sputum exam, MAST, Total IgE, serum Eosinophil count, FENO will be done at the time of registration and 6\~8 weeks later.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ILD registry(Seoul National University IRB, IRB No. 1312-048-542), outpatient department, ward

You may qualify if:

  • IPF patients

You may not qualify if:

  • Patients on systemic steroid
  • Patients with acute exacerbation within the last 6 months
  • PFT+BDR, MBPT contra-indication
  • SpO2 \< 90%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Officials

  • Choi Sun Mi

    Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine and Lung institute, Seoul National University College of Medicine, Seoul, Korea

    PRINCIPAL INVESTIGATOR

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
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 18, 2017

First Posted

July 12, 2017

Study Start

June 7, 2017

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

July 12, 2017

Record last verified: 2017-07

Locations

KR(1)