Epidemiology of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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|ClinicalTrials.gov Identifier: NCT02128529|
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : November 2, 2016
|Condition or disease|
|Chronic Obstructive Pulmonary Disease Chronic Bronchitis|
|Study Type :||Observational|
|Actual Enrollment :||976 participants|
|Official Title:||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|
|Study Start Date :||October 2010|
|Primary Completion Date :||April 2011|
|Study Completion Date :||April 2011|
Chronic obstructive pulmonary disease
Patients with chronic obstructive pulmonary disease will undergo a single visit with the collection of data from his/her records.
- Percentage of Participants with Chronic Bronchitis [ Time Frame: 2 years prior to the study visit on Day 1 ]Chronic bronchitis is defined as the presence of cough and sputum production for at least 3 months in each of 2 consecutive years.
- Exacerbation Rate [ Time Frame: 12 Months prior to the study visit ]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.
- Percentage of Participants with Moderate, Severe or Very Severe COPD [ Time Frame: At the study visit (Day 1) ]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.
- Percentage of Participants with Risk Factors [ Time Frame: 12 months prior to study visit ]Risk factors are defined as smoking status and exposure to environmental risk factors (mineral dusts, organic dusts, fumes and vapours or metallic dusts).
- Changes in Post-bronchodilator forced expiratory volume after 1 second (FEV1) [ Time Frame: At the study visit, and 6 months and 12 Months prior to study visit ]
- Percentage of Participants with Other Relevant Diseases [ Time Frame: 12 months prior to study visit ]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).
- COPD Treatment [ Time Frame: At the study visit (Day 1) ]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.
- Changes in post-bronchodilator ratio of FEV1 to forced vital capacity (FVC) [ Time Frame: At the study visit, and 6 months and 12 Months prior to study visit ]
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): NCT02128529
|Study Director:||AstraZeneca AstraZeneca||AstraZeneca|