Prevalence Study and Regular Practice Among General Practitioners in Populations at Risk of Chronic Obstructive Pulmonary Disease (COPD) in Latin America
PUMA PROJECT
1 other identifier
observational
1,907
4 countries
18
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2012
Shorter than P25 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2011
CompletedFirst Posted
Study publicly available on registry
December 16, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedApril 26, 2013
April 1, 2013
8 months
December 12, 2011
April 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Number of participants with an affirmative response to specific categories on the PUMA questionnaire.
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.
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.
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).
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.
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.
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)
Eligibility Criteria
Patients aged 40 or more, smokers or former smokers and/or people exposed to biomass combustion, who attend primary care consultation.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (18)
Research Site
Belén de Escobar, Buenos Aires, Argentina
Research Site
Ezeiza, Buenos Aires, Argentina
Research Site
Los Polvorines, Buenos Aires, Argentina
Research Site
Martínez, Buenos Aires, Argentina
Research Site
Quilmes, Buenos Aires, Argentina
Research Site
Ramos Mejía, Buenos Aires, Argentina
Research Site
Capital Federal, Buenos Aires F.D., Argentina
Research Site
Medellín, Antioquia, Colombia
Research Site
Barranquilla, Atlántico, Colombia
Research Site
Manizales, Caldas Department, Colombia
Research Site
Armenia, Quindío Department, Colombia
Research Site
Cali, Valle del Cauca Department, Colombia
Research Site
Montevideo, Montevideo Department, Uruguay
Research Site
Barquisimeto, Venezuela
Research Site
Caracas, Venezuela
Research Site
Maracaibo, Venezuela
Research Site
Porlamar, Venezuela
Research Site
Valencia, Venezuela
Related Publications (1)
Lopez Varela MV, Montes de Oca M, Rey A, Casas A, Stirbulov R, Di Boscio V; PUMA Team. Development of a simple screening tool for opportunistic COPD case finding in primary care in Latin America: The PUMA study. Respirology. 2016 Oct;21(7):1227-34. doi: 10.1111/resp.12834. Epub 2016 Jun 20.
PMID: 27319305DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Maria Montes de Oca, Internist - Pulmonologist
Universidad Central de Venezuela
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2011
First Posted
December 16, 2011
Study Start
February 1, 2012
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
April 26, 2013
Record last verified: 2013-04