Epidemiology of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease (COPD)
2016년 10월 31일 업데이트: AstraZeneca
A Cross-sectional Observational Study in Pulmonology Departments in Belgium and Luxembourg to Investigate the Epidemiology of Chronic Bronchitis in Patients Suffering From Moderate to Very Severe COPD
The purpose of this study was to investigate the prevalence of chronic bronchitis in patients suffering from moderate to very severe chronic obstructive pulmonary disease (COPD), and to assess the difference in exacerbation rates in patients suffering from moderate to very severe COPD with chronic bronchitis vs. a population of patients without chronic bronchitis.
연구 개요
상태
완전한
상세 설명
This was an observational study so participants only took medication that was prescribed by their regular healthcare provider.
No additional study medication was administered.
This study enrolled patients who were previously diagnosed with moderate to very severe chronic obstructive pulmonary disease (COPD).
This study looked at the prevalence of chronic bronchitis in patients suffering from moderate, severe or very severe COPD, and it also compared worsening of COPD in patients with or without chronic bronchitis.
This study enrolled 976 patients.
This multi-centre trial was conducted in Belgium and Luxembourg.
The overall time to participate in this study was at a single, regularly scheduled visit at the pulmonologists office.
There were no follow-up assessments for this study.
연구 유형
관찰
등록 (실제)
976
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
40년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
COPD patients with or without chronic bronchitis in Belgium and Luxembourg.
설명
Inclusion Criteria:
- 1. Written informed consent. 2. Age ≥ 40 years. 3. Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio (post-bronchodilator) <70%. 4. FEV1 (post-bronchodilator) < 80% of predicted.
Exclusion Criteria:
- 1. Moderate and severe exacerbations during the last 4 weeks. 2. Pregnancy. 3. Already participated in the study (allowed to participate only once).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Chronic obstructive pulmonary disease
Patients with chronic obstructive pulmonary disease will undergo a single visit with the collection of data from his/her records.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Participants with Chronic Bronchitis
기간: 2 years prior to the study visit on Day 1
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Chronic bronchitis is defined as the presence of cough and sputum production for at least 3 months in each of 2 consecutive years.
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2 years prior to the study visit on Day 1
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Exacerbation Rate
기간: 12 Months prior to the study visit
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An exacerbation is defined as an event in the natural course of the disease characterised by a change in the patient's baseline dyspnoea, cough, and/or sputum that is beyond normal day-to-day variations, is acute in onset, and may warrant a change in regular medication in a patient with underlying COPD for three or more days.
Exacerbation rate is defined as number of exacerbations per year.
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12 Months prior to the study visit
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Participants with Moderate, Severe or Very Severe COPD
기간: At the study visit (Day 1)
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COPD severity will be assessed based on post-bronchodilator forced expiratory volume after 1 second (FEV1) and post-bronchodilator ratio of FEV1 to forced vital capacity (FVC) and then classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD): Moderate - FEV1/FVC<0.7, FEV1 50-79% normal; Severe - FEV1/FVC<0.70, FEV1 30-49% normal; Very Severe - FEV1/FVC<0.70, FEV1 <30% predicted or FEV1<50% predicted plus chronic respiratory failure.
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At the study visit (Day 1)
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Percentage of Participants with Risk Factors
기간: 12 months prior to study visit
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Risk factors are defined as smoking status and exposure to environmental risk factors (mineral dusts, organic dusts, fumes and vapours or metallic dusts).
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12 months prior to study visit
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Changes in Post-bronchodilator forced expiratory volume after 1 second (FEV1)
기간: At the study visit, and 6 months and 12 Months prior to study visit
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At the study visit, and 6 months and 12 Months prior to study visit
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Percentage of Participants with Other Relevant Diseases
기간: 12 months prior to study visit
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Relevant disease are defined as respiratory diseases (allergy, asthma, chronic respiratory failure), cardiovascular diseases (ischaemic heart disease, heart failure, hypertension), and other diseases (which could be related to COPD) (osteoporosis, skeletal muscle wasting, cachexia, diabetes mellitus, depression, normocytic, anaemia, gastroesophageal reflux disease and lung cancer).
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12 months prior to study visit
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COPD Treatment
기간: At the study visit (Day 1)
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COPD treatments are defined as inhaled therapies, oral therapies and other therapies administered within the last 12 months as influenza vaccination and smoking cessation therapy.
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At the study visit (Day 1)
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Changes in post-bronchodilator ratio of FEV1 to forced vital capacity (FVC)
기간: At the study visit, and 6 months and 12 Months prior to study visit
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At the study visit, and 6 months and 12 Months prior to study visit
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스폰서
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연구 주요 날짜
연구 시작
2010년 10월 1일
기본 완료 (실제)
2011년 4월 1일
연구 완료 (실제)
2011년 4월 1일
연구 등록 날짜
최초 제출
2014년 4월 29일
QC 기준을 충족하는 최초 제출
2014년 4월 29일
처음 게시됨 (추정)
2014년 5월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 11월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 10월 31일
마지막으로 확인됨
2016년 9월 1일
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