Epidemiology of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Chronic Bronchitis

• Registration Number: NCT02128529
• Lead Sponsor: AstraZeneca

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 Timeline

• Study Start: 2010-10
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2014-04-29
• Study First Submitted QC: 2014-04-29
• Study First Posted: 2014-05-01
• Status Verified: 2016-09
• Last Update Submitted: 2016-10-31
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 976

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Chronic Bronchitis	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	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 Outcome Measures

Name	Time	Method
Percentage of Participants with Risk Factors	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)	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	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	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)	At the study visit, and 6 months and 12 Months prior to study visit
Percentage of Participants with Moderate, Severe or Very Severe COPD	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.