Clinical trial NCT02128529: Epidemiology of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Keywords: COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-05-01
Enrollment: 976
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients with or without chronic bronchitis in Belgium and Luxembourg.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Participants with Chronic Bronchitis
timeFrame: 2 years prior to the study visit on Day 1
measure: Exacerbation Rate
timeFrame: 12 Months prior to the study visit
Secondary outcomes:
measure: Percentage of Participants with Moderate, Severe or Very Severe COPD
timeFrame: At the study visit (Day 1)
measure: Percentage of Participants with Risk Factors
timeFrame: 12 months prior to study visit
measure: Changes in Post-bronchodilator forced expiratory volume after 1 second (FEV1)
timeFrame: At the study visit, and 6 months and 12 Months prior to study visit
measure: Percentage of Participants with Other Relevant Diseases
timeFrame: 12 months prior to study visit
measure: COPD Treatment
timeFrame: At the study visit (Day 1)
measure: Changes in post-bronchodilator ratio of FEV1 to forced vital capacity (FVC)
timeFrame: At the study visit, and 6 months and 12 Months prior to study visit
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: