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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03215147
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 32.7
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis; Airway Disease	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

1. Identify the symptomatic improvement after active treatment for the airway diseases

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prevalence and Impact on Quality of Life of Airway Disease in Patients With Idiopathic Pulmonary Fibrosis
• Actual Study Start Date: Jun 7, 2017
• Anticipated Primary Completion Date: Feb 28, 2020
• Anticipated Study Completion Date: Feb 28, 2020

Outcome Measures

Primary Outcome Measures

1. Number of participants who have asthma combined with idiopathic pulmonary fibrosis [Through study completion, an average of 2 year]

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

2. Number of participants who have COPD combined with idiopathic pulmonary fibrosis [Through study completion, an average of 2 year]

   Confirmation of COPD : pulmonary function test with bronchodilator response

3. Number of participants who have Eosinophilic bronchitis combined with idiopathic pulmonary fibrosis [Through study completion, an average of 2 year]

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

Secondary Outcome Measures

1. 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]

   Quality of life : COPD assessment test(CAT)

2. 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]

   Quality of life : St George's Respiratory Questionnaire(SGRQ)

3. 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]

   Symptom severity : mMRC

4. 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]

   Symptom severity : 6 minute walking test(6MWT)

5. 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]

   Symptom severity : EQ-5D-VAS

6. The difference of CQLQ 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]

   Symptom severity : Cough Quality-of-Life Questionnaire(CQLQ)

7. Checking the improvement of CAT score to assess the quality of life between patients with airway disease and those without airway disease [After treating the airway disease for 6~8 weeks]

   Quality of life : COPD assessment test(CAT)

8. Checking the improvement of SGRQ score to assess the quality of life between patients with airway disease and those without airway disease [After treating the airway disease for 6~8 weeks]

   Quality of life : St George's Respiratory Questionnaire(SGRQ)

9. Checking the improvement of mMRC scores to assess symptom severity between patients with airway disease and those without airway disease [After treating the airway disease for 6~8 weeks]

   Symptom severity : mMRC

10. Checking the improvement of distance of 6MWT to assess symptom severity between patients with airway disease and those without airway disease [After treating the airway disease for 6~8 weeks]

    Symptom severity : 6 minute walking test(6MWT)

11. Checking the improvement of EQ-5D-VAS score to assess symptom severity between patients with airway disease and those without airway disease [After treating the airway disease for 6~8 weeks]

    Symptom severity : EQ-5D-VAS

12. Checking the improvement of CQLQ to assess symptom severity between patients with airway disease and those without airway disease [After treating the airway disease for 6~8 weeks]

    Symptom severity : Cough Quality-of-Life Questionnaire(CQLQ)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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%

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sun Mi Choi, Assistant professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03215147
• Other Study ID Numbers: ILD Asthma
• First Posted: Jul 12, 2017
• Last Update Posted: Jul 12, 2017
• Last Verified: Jul 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sun Mi Choi, Assistant professor, Seoul National University Hospital: Idiopathic Pulmonary Fibrosis; Airway Disease
• Additional relevant MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis

Study Results

No Results Posted as of Jul 12, 2017