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

NCT02128529 | Completed

• 1 other identifier: RO-2455-401-BE
• Study Type: observational
• Target: 976
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease; Chronic Bronchitis

Keywords

COPD

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants with Chronic Bronchitis

  Chronic bronchitis is defined as the presence of cough and sputum production for at least 3 months in each of 2 consecutive years.

  2 years prior to the study visit on Day 1

• Exacerbation Rate

  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.

  12 Months prior to the study visit

Secondary Outcomes (6)

• 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)

Study Arms (1)

Chronic obstructive pulmonary disease

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients with or without chronic bronchitis in Belgium and Luxembourg.

You may qualify if:

• \. 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.

You may not qualify if:

• \. Moderate and severe exacerbations during the last 4 weeks. 2. Pregnancy. 3. Already participated in the study (allowed to participate only once).

Sponsors & Collaborators

• AstraZeneca: lead

Related Links

• Full publication

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 1, 2014
• Study Start: October 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-09