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NCT Number: NCT02128529

Epidemiology of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease (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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Bronchial Diseases Bronchitis Bronchitis, Chronic Chronic Bronchitis Chronic Disease Disease Attributes Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

  1. 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.

  2. 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).

  3. 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

  4. 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).

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 1, 2014
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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