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

AstraZeneca

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT02100332

U1111-1152-9289 (Registry Identifier)

RO-2455-402-IT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 860 patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No 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

Trial design

860 participants in 1 patient group

Chronic obstructive pulmonary disease

Description:

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