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

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.

Study Overview

• Status: Unknown
• Conditions: Idiopathic Pulmonary Fibrosis; Airway Disease
• Intervention / Treatment: Diagnostic test: Confirmation of Airway Disease combined with IPF

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

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Choi Sun Mi; Phone Number: 02-2072-4915; Email: sunmich81@gmail.com
• Study Contact Backup: Name: PARK HEEMOON; Email: coramdeo33@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Choi Sun Mi; Phone Number: 02-2072-4915; Email: sunmich81@gmail.com
    • Contact: PARK HEEMOON; Email: coramdeo33@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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%

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference of CAT scores between patients with airway disease and those without airway disease.	Quality of life : COPD assessment test(CAT)	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.	Quality of life : St George's Respiratory Questionnaire(SGRQ)	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.	Symptom severity : mMRC	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.	Symptom severity : 6 minute walking test(6MWT)	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.	Symptom severity : EQ-5D-VAS	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.	Symptom severity : Cough Quality-of-Life Questionnaire(CQLQ)	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	Quality of life : COPD assessment test(CAT)	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	Quality of life : St George's Respiratory Questionnaire(SGRQ)	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	Symptom severity : mMRC	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	Symptom severity : 6 minute walking test(6MWT)	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	Symptom severity : EQ-5D-VAS	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	Symptom severity : Cough Quality-of-Life Questionnaire(CQLQ)	After treating the airway disease for 6~8 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2017
• Primary Completion (Anticipated): February 28, 2020
• Study Completion (Anticipated): February 28, 2020

Study Registration Dates

• First Submitted: June 18, 2017
• First Submitted That Met QC Criteria: July 9, 2017
• First Posted (Actual): July 12, 2017

Study Record Updates

• Last Update Posted (Actual): July 12, 2017
• Last Update Submitted That Met QC Criteria: July 9, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Idiopathic Pulmonary Fibrosis; Airway Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: ILD Asthma

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No