Prevalence Study and Regular Practice Among General Practitioners in Populations at Risk of Chronic Obstructive Pulmonary Disease (COPD) in Latin America (PUMA PROJECT)
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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 |
|---|
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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 |
- 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) |
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 |
Patients aged 40 or more, smokers or former smokers and/or people exposed to biomass combustion, who attend primary care consultation.
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| 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 | |
| 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 Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013