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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02100332

Acronym

PREFER

Enrollment

860

Registered

2014-03-31

Start date

2012-11-30

Completion date

2014-07-31

Last updated

2016-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Drug Therapy

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

45 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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	—

Countries

Italy

Outcome results