Prevalence and Impact on Quality of Life of Airway Disease in Patients With Idiopathic Pulmonary Fibrosis
2017년 7월 9일 업데이트: Sun Mi Choi, Seoul National University Hospital
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.
연구 개요
상세 설명
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
연구 유형
관찰
등록 (예상)
100
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Seoul, 대한민국
- 모병
- Seoul National University Hospital
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연락하다:
- Choi Sun Mi
- 전화번호: 02-2072-4915
- 이메일: sunmich81@gmail.com
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연락하다:
- PARK HEEMOON
- 이메일: coramdeo33@gmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
ILD registry(Seoul National University IRB, IRB No. 1312-048-542), outpatient department, ward
설명
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%
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of participants who have asthma combined with idiopathic pulmonary fibrosis
기간: Through study completion, an average of 2 year
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Confirmation of asthma : pulmonary function test with bronchodilator response or Methacholine provocation test
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Through study completion, an average of 2 year
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Number of participants who have COPD combined with idiopathic pulmonary fibrosis
기간: Through study completion, an average of 2 year
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Confirmation of COPD : pulmonary function test with bronchodilator response
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Through study completion, an average of 2 year
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Number of participants who have Eosinophilic bronchitis combined with idiopathic pulmonary fibrosis
기간: Through study completion, an average of 2 year
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Confirmation of Eosinophilic bronchitis : pulmonary function test with bronchodilator response, induced sputum
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Through study completion, an average of 2 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The difference of CAT scores between patients with airway disease and those without airway disease.
기간: baseline and after treating the airway disease for 6~8 weeks
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Quality of life : COPD assessment test(CAT)
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baseline and after treating the airway disease for 6~8 weeks
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The difference of SGRQ scores to assess quality of life between patients with airway disease and those without airway disease.
기간: baseline and after treating the airway disease for 6~8 weeks
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Quality of life : St George's Respiratory Questionnaire(SGRQ)
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baseline and after treating the airway disease for 6~8 weeks
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The difference of mMRC scores to assess symptom severity between patients with airway disease and those without airway disease.
기간: baseline and after treating the airway disease for 6~8 weeks
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Symptom severity : mMRC
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baseline and after treating the airway disease for 6~8 weeks
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The difference of distance of 6MWT to assess symptom severity between patients with airway disease and those without airway disease.
기간: baseline and after treating the airway disease for 6~8 weeks
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Symptom severity : 6 minute walking test(6MWT)
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baseline and after treating the airway disease for 6~8 weeks
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The difference of EQ-5D-VAS scores to assess symptom severity between patients with airway disease and those without airway disease.
기간: baseline and after treating the airway disease for 6~8 weeks
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Symptom severity : EQ-5D-VAS
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baseline and after treating the airway disease for 6~8 weeks
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The difference of CQLQ scores to assess symptom severity between patients with airway disease and those without airway disease.
기간: baseline and after treating the airway disease for 6~8 weeks
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Symptom severity : Cough Quality-of-Life Questionnaire(CQLQ)
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baseline and after treating the airway disease for 6~8 weeks
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Checking the improvement of CAT score to assess the quality of life between patients with airway disease and those without airway disease
기간: After treating the airway disease for 6~8 weeks
|
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
기간: After treating the airway disease for 6~8 weeks
|
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
기간: After treating the airway disease for 6~8 weeks
|
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
기간: After treating the airway disease for 6~8 weeks
|
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
기간: After treating the airway disease for 6~8 weeks
|
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
기간: After treating the airway disease for 6~8 weeks
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Symptom severity : Cough Quality-of-Life Questionnaire(CQLQ)
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After treating the airway disease for 6~8 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: 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
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 6월 7일
기본 완료 (예상)
2020년 2월 28일
연구 완료 (예상)
2020년 2월 28일
연구 등록 날짜
최초 제출
2017년 6월 18일
QC 기준을 충족하는 최초 제출
2017년 7월 9일
처음 게시됨 (실제)
2017년 7월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 7월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 7월 9일
마지막으로 확인됨
2017년 7월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
특발성 폐 섬유증에 대한 임상 시험
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