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

Chronic Obstructive Pulmonary Disease Clinical Trial

— PUMA PROJECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01493544
• Other study ID #: NIS-RLA-XXX-2011/1
• Status: Completed
• Phase: N/A
• First received: December 12, 2011
• Last updated: April 25, 2013
• Start date: February 2012
• Est. completion date: October 2012

Study information

• Verified date: April 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Human Research Bioethics CommitteeBrazil: National Committee of Ethics in ResearchColombia: Institutional Review BoardUruguay: Ethical CommitteeVenezuela: Indendent Ethical Committee
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1907
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Argentina	Research Site	Capital Federal
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
Colombia	Research Site	Armenia	Quindio
Colombia	Research Site	Barranquilla	Atlantico
Colombia	Research Site	Cali	Valle Del Cauca
Colombia	Research Site	Manizales	Caldas
Colombia	Research Site	Medellin	Antioquia
Uruguay	Research Site	Montevideo
Venezuela	Research Site	Barquisimeto
Venezuela	Research Site	Caracas
Venezuela	Research Site	Maracaibo
Venezuela	Research Site	Porlamar
Venezuela	Research Site	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Argentina,  Colombia,  Uruguay,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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)	No
Primary	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)	No
Primary	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	No
Primary	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)	No
Primary	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)	No