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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 976
- Primary Endpoint
- Percentage of Participants with Chronic Bronchitis
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Written informed consent.
- •Age ≥ 40 years.
- •Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio (post-bronchodilator) <70%.
- •FEV1 (post-bronchodilator) < 80% of predicted.
Exclusion Criteria
- •Moderate and severe exacerbations during the last 4 weeks.
- •Already participated in the study (allowed to participate only once).
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Percentage of Participants with Moderate, Severe or Very Severe COPD(At the study visit (Day 1))
- Percentage of Participants with Risk Factors(12 months prior to study visit)
- Changes in Post-bronchodilator forced expiratory volume after 1 second (FEV1)(At the study visit, and 6 months and 12 Months prior to study visit)
- Percentage of Participants with Other Relevant Diseases(12 months prior to study visit)
- COPD Treatment(At the study visit (Day 1))
- Changes in post-bronchodilator ratio of FEV1 to forced vital capacity (FVC)(At the study visit, and 6 months and 12 Months prior to study visit)