A Cross Sectional Disease/Condition Focused Observational Study on Chronic Obstructive Pulmonary Disease (COPD)

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT02100332
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to establish the prevalence of comorbidities in Italian patients with chronic bronchitis with at least 2 exacerbations per year, and to document the appropriateness of instrumental diagnostic tests, such as spirometry of these patients.

Detailed Description

This is an observational study so participants will only take medication that is presently prescribed by their regular healthcare provider. No additional study medication will be administered. This study will enroll patients who have been previously diagnosed with COPD. This study will look at the medical history and other diseases that have been diagnosed in people who also have COPD.

The study will enroll approximately 3000 patients.

This multi-centre trial will be conducted in Italy. The overall time to participate in this study is at a single, regularly scheduled visit at the pulmonologists office. There will not be any follow up assessments.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2014-02-06
• Study First Submitted QC: 2014-03-26
• Study First Posted: 2014-03-31
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2016-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 860

Inclusion Criteria

1. Age 45-85, of either gender.
2. Signed informed consent.
3. Known COPD documented by spirometric exams showing fixed non reversible respiratory obstruction.
4. Forced Expired Volume measured after 1 second expiration (FEV-1) < 50% in a previous test (no time limits).
5. Symptoms of chronic bronchitis : chronic productive cough for 3 months at least in each of the 2 years prior to the index visits.
6. On treatment of bronchodilators (no restrictions) for the last 12 months at least.
7. History of at least 2 exacerbations (moderate/severe) in the last 12 months prior to index visit.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of Comorbidities	Comorbidities captured at the index visit and related to 12 Months Prior to Study Index Visit	The following comorbidities were accounted for (from the patient records): arterial hypertension, ischemic heart disease, other cardiac disorders, arrhythmia, congestive heart failure, diabetes, metabolic syndrome, known osteoporosis, depression, and chronic renal insufficiency.
Percentage of Participants having Annual Spirometric Tests	12 months prior and up to the Study Index Visit