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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prevalence of Comorbidities of COPD in the Exacerbator Phenotype - A Cross Sectional Disease/Condition Focused Observational Study on COPD

Conditions
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Chronic Obstructive Pulmonary Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 45-85, of either gender. Signed informed consent. Known COPD documented by spirometric exams showing fixed non reversible respiratory obstruction. Forced Expired Volume measured after 1 second expiration (FEV-1) < 50% in a previous test (no time limits). Symptoms of chronic bronchitis : chronic productive cough for 3 months at least in each of the 2 years prior to the index visits. On treatment of bronchodilators (no restrictions) for the last 12 months at least. History of at least 2 exacerbations (moderate/severe) in the last 12 months prior to index visit. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic obstructive pulmonary disease<br>Patients with chronic obstructive pulmonary disease will undergo a single visit with the collection of data from his/her records. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Comorbidities | 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. | Comorbidities captured at the index visit and related to 12 Months Prior to Study Index Visit | 
| Percentage of Participants having Annual Spirometric Tests |  | 12 months prior and up to the Study Index Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy