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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03215147
• Other study ID #: ILD Asthma
• Status: Recruiting
• Phase: N/A
• First received: June 18, 2017
• Last updated: July 9, 2017
• Start date: June 7, 2017
• Est. completion date: February 28, 2020

Study information

• Verified date: July 2017
• Source: Seoul National University Hospital
• Contact: Choi Sun Mi
• Phone: 02-2072-4915
• Email: sunmich81[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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%

Related Conditions & MeSH terms

• Airway Disease
• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Diagnostic Test:
• Confirmation of Airway Disease combined with IPF
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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