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

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ClinicalTrials.gov Identifier: NCT03215147
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):
Sun Mi Choi, Seoul National University Hospital

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


Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: Prevalence and Impact on Quality of Life of Airway Disease in Patients With Idiopathic Pulmonary Fibrosis
Actual Study Start Date : June 7, 2017
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Number of participants who have asthma combined with idiopathic pulmonary fibrosis [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: After treating the airway disease for 6~8 weeks ]
    Symptom severity : Cough Quality-of-Life Questionnaire(CQLQ)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ILD registry(Seoul National University IRB, IRB No. 1312-048-542), outpatient department, ward
Criteria

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03215147


Contacts
Contact: Choi Sun Mi 02-2072-4915 sunmich81@gmail.com
Contact: PARK HEEMOON coramdeo33@gmail.com

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

Responsible Party: Sun Mi Choi, Assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03215147     History of Changes
Other Study ID Numbers: ILD Asthma
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 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, Seoul National University Hospital:
Idiopathic Pulmonary Fibrosis
Airway Disease

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial