Prevalence Study and Regular Practice Among General Practitioners in Populations at Risk of Chronic Obstructive Pulmonary Disease (COPD) in Latin America (PUMA PROJECT)

April 25, 2013 updated by: AstraZeneca

Prevalence Study and Regular Practice (Diagnosis and Treatment) Among General Practitioners in Populations at Risk of COPD in Latin America

PUMA is an observational, multicentre, multinational, cross-sectional study with primary care physicians (primary care, general and family physicians). Participants will be selected sequentially among patients at risk for Chronic Obstructive Pulmonary Disease (COPD) who attend primary care consultation (primary care, general and family physicians). The inclusion visit will be a regularly scheduled or spontaneous consultation for patients, and this appointment with the physician will not depend on the study. During the appointment, data will be collected from the patient and the physician.

Study Overview

Status

Completed

Conditions

Detailed Description

PREVALENCE STUDY AND REGULAR PRACTICE (DIAGNOSIS AND TREATMENT) AMONG GENERAL PRACTICIONERS IN POPULATIONS AT RISK OF COPD IN LATIN AMERICA

Study Type

Observational

Enrollment (Actual)

1907

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

  • Argentina
      • Capital Federal, Argentina
        • Research Site
    • Buenos Aires
      • Escobar, Buenos Aires, Argentina
        • Research Site
      • Ezeiza, Buenos Aires, Argentina
        • Research Site
      • Los Polvorines, Buenos Aires, Argentina
        • Research Site
      • Martinez, Buenos Aires, Argentina
        • Research Site
      • Quilmes, Buenos Aires, Argentina
        • Research Site
      • Ramos Mejia, Buenos Aires, Argentina
        • Research Site
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Research Site
    • Atlantico
      • Barranquilla, Atlantico, Colombia
        • Research Site
    • Caldas
      • Manizales, Caldas, Colombia
        • Research Site
    • Quindio
      • Armenia, Quindio, Colombia
        • Research Site
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia
        • Research Site
  • Uruguay
      • Montevideo, Uruguay
        • Research Site
  • Venezuela
      • Barquisimeto, Venezuela
        • Research Site
      • Caracas, Venezuela
        • Research Site
      • Maracaibo, Venezuela
        • Research Site
      • Porlamar, Venezuela
        • Research Site
      • Valencia, Venezuela
        • Research Site

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged 40 or more, smokers or former smokers and/or people exposed to biomass combustion, who attend primary care consultation.

Description

Inclusion Criteria:

  • Men or women aged more or equal than 40
  • Current or former smokers and/or patients exposed to biomass combustion:

Cigarettes: more or equal than 10 packs/year; Pipes: more or equal than 50 pipes/year; Cigars: more or equal than 50 cigars/year; Combustion: more or equal 100 hours/firewood/year

Exclusion Criteria:

  • Pregnancy
  • Patients with contraindications for spirometry
  • Physical or mental disability rendering the patient unable to undergo a spirometry test and to contribute data to the study
  • Heart rate ≥ 120 beats by minute
  • Patients currently undergoing treatment for tuberculosis
  • A patient who is participating in an interventional clinical trial or was previously included in this study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with an affirmative response to specific categories on the PUMA questionnaire.
Time Frame: Baseline
PUMA Questionnaire: Based on the PLATINO questionnaire. Applied to patients to describe different aspects potentially related to Chronic Obstructive Pulmonary Disease (COPD) such as: respiratory symptoms, smoking, respiratory medication, health care resources usage, comorbidieties, etc., as well as the registration of procedures (spirometry and oximetry) carried out and anthropometric data.
Baseline
FEV1 spirometry measures.
Time Frame: Baseline and visit 2 up to 4 weeks after baseline (if applicable)

FEV1 is the volume of air expelled from the lungs in 1 second.

The second visit will be scheduled only for those patients who do not meet criteria for deferring spirometry.
Baseline and visit 2 up to 4 weeks after baseline (if applicable)
SaO2 (Arterial Oxygen Saturation) - pulse oximetry.
Time Frame: Baseline and visit 2 up to 4 weeks after baseline (if applicable)
The second visit will be scheduled only for those patients who do not meet criteria for deferring spirometry.
Baseline and visit 2 up to 4 weeks after baseline (if applicable)
Number of participants with an affirmative response to specific categories on the Medical History Questionnaire (if applicable).
Time Frame: Baseline
Questionnaire based on the patient's personal medical history at the site. Its application will be subject to the existence of a prior medical history for the patient at site. If the patient has no prior medical history at site, then this questionnaire will not apply.
Baseline
FEV1/FVC spirometry measures.
Time Frame: Baseline and visit 2 up to 4 weeks after baseline (if applicable)

Ratio of Forced Expiratory Volume in 1 second (volume of air expelled from the lungs in 1 second) by the Forced Vital Capacity (FVC, the volume of air that can forcibly be blown out after full inspiration) is a spirometric measure (lung function test) used to demonstrate airway obstruction.

The second visit will be scheduled only for those patients who do not meet criteria for deferring spirometry.
Baseline and visit 2 up to 4 weeks after baseline (if applicable)
Heart rate (HR) - pulse oximetry.
Time Frame: Baseline and visit 2 up to 4 weeks after baseline (if applicable)
The second visit will be scheduled only for those patients who do not meet criteria for deferring spirometry.
Baseline and visit 2 up to 4 weeks after baseline (if applicable)

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Chair: Maria Montes de Oca, Internist - Pulmonologist, Universidad Central de Venezuela

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

December 12, 2011

First Submitted That Met QC Criteria

December 15, 2011

First Posted (Estimate)

December 16, 2011

Study Record Updates

Last Update Posted (Estimate)

April 26, 2013

Last Update Submitted That Met QC Criteria

April 25, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-RLA-XXX-2011/1

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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