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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03215147
Enrollment
100
Registered
2017-07-12
Start date
2017-06-07
Completion date
2020-02-28
Last updated
2017-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Disease, Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis, Airway Disease

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.

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

Interventions

DIAGNOSTIC_TESTConfirmation 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.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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%

Design outcomes

Primary

MeasureTime frameDescription
Number of participants who have asthma combined with idiopathic pulmonary fibrosisThrough study completion, an average of 2 yearConfirmation of asthma : pulmonary function test with bronchodilator response or Methacholine provocation test
Number of participants who have COPD combined with idiopathic pulmonary fibrosisThrough study completion, an average of 2 yearConfirmation of COPD : pulmonary function test with bronchodilator response
Number of participants who have Eosinophilic bronchitis combined with idiopathic pulmonary fibrosisThrough study completion, an average of 2 yearConfirmation of Eosinophilic bronchitis : pulmonary function test with bronchodilator response, induced sputum

Secondary

MeasureTime frameDescription
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 weeksSymptom severity : 6 minute walking test(6MWT)
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 weeksSymptom severity : EQ-5D-VAS
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 weeksSymptom severity : Cough Quality-of-Life Questionnaire(CQLQ)
Checking the improvement of CAT score to assess the quality of life between patients with airway disease and those without airway diseaseAfter treating the airway disease for 6~8 weeksQuality of life : COPD assessment test(CAT)
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 weeksQuality of life : COPD assessment test(CAT)
Checking the improvement of mMRC scores to assess symptom severity between patients with airway disease and those without airway diseaseAfter treating the airway disease for 6~8 weeksSymptom severity : mMRC
Checking the improvement of distance of 6MWT to assess symptom severity between patients with airway disease and those without airway diseaseAfter treating the airway disease for 6~8 weeksSymptom severity : 6 minute walking test(6MWT)
Checking the improvement of EQ-5D-VAS score to assess symptom severity between patients with airway disease and those without airway diseaseAfter treating the airway disease for 6~8 weeksSymptom severity : EQ-5D-VAS
Checking the improvement of CQLQ to assess symptom severity between patients with airway disease and those without airway diseaseAfter treating the airway disease for 6~8 weeksSymptom severity : Cough Quality-of-Life Questionnaire(CQLQ)
Checking the improvement of SGRQ score to assess the quality of life between patients with airway disease and those without airway diseaseAfter treating the airway disease for 6~8 weeksQuality of life : St George's Respiratory Questionnaire(SGRQ)
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 weeksQuality of life : St George's Respiratory Questionnaire(SGRQ)
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 weeksSymptom severity : mMRC

Countries

South Korea

Contacts

Primary ContactChoi Sun Mi
sunmich81@gmail.com02-2072-4915
Backup ContactPARK HEEMOON
coramdeo33@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026