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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT01493544
• Lead Sponsor: AstraZeneca

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-16
• Study Start: 2012-02
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-25
• Last Update Posted: 2013-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1907

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with an affirmative response to specific categories on the PUMA questionnaire.	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.
FEV1 spirometry measures.	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.
SaO2 (Arterial Oxygen Saturation) - pulse oximetry.	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.
Number of participants with an affirmative response to specific categories on the Medical History Questionnaire (if applicable).	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.
FEV1/FVC spirometry measures.	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.
Heart rate (HR) - pulse oximetry.	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.

Trial Locations

Locations (1)

Research Site; 🇻🇪 Valencia, Venezuela