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

December 2, 2016 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

860

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Veruno (Novara), Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with COPD will be enrolled at hospital and pulmonology departments in Italy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Chronic obstructive pulmonary disease
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?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

February 6, 2014

First Submitted That Met QC Criteria

March 26, 2014

First Posted (Estimate)

March 31, 2014

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

December 2, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RO-2455-402-IT
  • U1111-1152-9289 (Registry Identifier: WHO (UTN))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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