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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

860 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-07-31

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.

Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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Drug Therapy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Chronic obstructive pulmonary disease

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AstraZeneca AstraZeneca

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Veruno (Novara), , Italy

Site Status

Countries

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Italy

Other Identifiers

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U1111-1152-9289

Identifier Type: REGISTRY

Identifier Source: secondary_id

RO-2455-402-IT

Identifier Type: -

Identifier Source: org_study_id