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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01493544
First received: December 12, 2011
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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.


Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prevalence Study and Regular Practice (Diagnosis and Treatment) Among General Practitioners in Populations at Risk of COPD in Latin America

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of participants with an affirmative response to specific categories on the PUMA questionnaire. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • FEV1 spirometry measures. [ Time Frame: Baseline and visit 2 up to 4 weeks after baseline (if applicable) ] [ Designated as safety issue: No ]

    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.


  • SaO2 (Arterial Oxygen Saturation) - pulse oximetry. [ Time Frame: Baseline and visit 2 up to 4 weeks after baseline (if applicable) ] [ Designated as safety issue: No ]
    The second visit will be scheduled only for those patients who do not meet criteria for deferring spirometry.

  • Number of participants with an affirmative response to specific categories on the Medical History Questionnaire (if applicable). [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • FEV1/FVC spirometry measures. [ Time Frame: Baseline and visit 2 up to 4 weeks after baseline (if applicable) ] [ Designated as safety issue: No ]

    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.


  • Heart rate (HR) - pulse oximetry. [ Time Frame: Baseline and visit 2 up to 4 weeks after baseline (if applicable) ] [ Designated as safety issue: No ]
    The second visit will be scheduled only for those patients who do not meet criteria for deferring spirometry.


Enrollment: 1907
Study Start Date: February 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493544

Locations
Argentina
Research Site
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
Capital Federal, Argentina
Colombia
Research Site
Medellin, Antioquia, Colombia
Research Site
Barranquilla, Atlantico, Colombia
Research Site
Manizales, Caldas, Colombia
Research Site
Armenia, Quindio, Colombia
Research Site
Cali, Valle Del Cauca, Colombia
Uruguay
Research Site
Montevideo, Uruguay
Venezuela
Research Site
Barquisimeto, Venezuela
Research Site
Caracas, Venezuela
Research Site
Maracaibo, Venezuela
Research Site
Porlamar, Venezuela
Research Site
Valencia, Venezuela
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Maria Montes de Oca, Internist - Pulmonologist Universidad Central de Venezuela
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01493544     History of Changes
Other Study ID Numbers: NIS-RLA-XXX-2011/1
Study First Received: December 12, 2011
Last Updated: April 25, 2013
Health Authority: Argentina: Human Research Bioethics Committee
Brazil: National Committee of Ethics in Research
Colombia: Institutional Review Board
Uruguay: Ethical Committee
Venezuela: Indendent Ethical Committee

Keywords provided by AstraZeneca:
COPD
smokers
primary care

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014