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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
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Chronic Obstructive Pulmonary Disease 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
Actual Enrollment : 976 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Chronic obstructive pulmonary disease
Patients with chronic obstructive pulmonary disease will undergo a single visit with the collection of data from his/her records.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COPD patients with or without chronic bronchitis in Belgium and Luxembourg.
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).
Contacts and Locations

Information from the National Library of Medicine

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


Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca AstraZeneca AstraZeneca
More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02128529     History of Changes
Other Study ID Numbers: RO-2455-401-BE
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: September 2016

Keywords provided by AstraZeneca:
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchitis
Acute Disease
Bronchitis, Chronic
Respiratory Tract Diseases
Bronchial Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes