Clinical trial NCT01493544: Prevalence Study and Regular Practice Among General Practitioners in Populations at Risk of Chronic Obstructive Pulmonary Disease (COPD) in Latin America
Official title: Prevalence Study and Regular Practice (Diagnosis and Treatment) Among General Practitioners in Populations at Risk of COPD in Latin America
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
smokers
primary care
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-12-16
Enrollment: 1907
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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

Eligibility 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

Primary outcomes:
measure: Number of participants with an affirmative response to specific categories on the PUMA questionnaire.
timeFrame: Baseline
measure: FEV1 spirometry measures.
timeFrame: Baseline and visit 2 up to 4 weeks after baseline (if applicable)
measure: SaO2 (Arterial Oxygen Saturation) - pulse oximetry.
timeFrame: Baseline and visit 2 up to 4 weeks after baseline (if applicable)
measure: Number of participants with an affirmative response to specific categories on the Medical History Questionnaire (if applicable).
timeFrame: Baseline
measure: FEV1/FVC spirometry measures.
timeFrame: Baseline and visit 2 up to 4 weeks after baseline (if applicable)
measure: Heart rate (HR) - pulse oximetry.
timeFrame: Baseline and visit 2 up to 4 weeks after baseline (if applicable)
Secondary outcomes:
Other outcomes:
Locations:
city: Escobar
country: Argentina
facility: Research Site
state: Buenos Aires
city: Ezeiza
country: Argentina
facility: Research Site
state: Buenos Aires
city: Los Polvorines
country: Argentina
facility: Research Site
state: Buenos Aires
city: Martinez
country: Argentina
facility: Research Site
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Research Site
state: Buenos Aires
city: Ramos Mejia
country: Argentina
facility: Research Site
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Research Site
city: Medellin
country: Colombia
facility: Research Site
state: Antioquia
city: Barranquilla
country: Colombia
facility: Research Site
state: Atlantico
city: Manizales
country: Colombia
facility: Research Site
state: Caldas
city: Armenia
country: Colombia
facility: Research Site
state: Quindio
city: Cali
country: Colombia
facility: Research Site
state: Valle Del Cauca
city: Montevideo
country: Uruguay
facility: Research Site
city: Barquisimeto
country: Venezuela
facility: Research Site
city: Caracas
country: Venezuela
facility: Research Site
city: Maracaibo
country: Venezuela
facility: Research Site
city: Porlamar
country: Venezuela
facility: Research Site
city: Valencia
country: Venezuela
facility: Research Site
Study officials:
affiliation: Universidad Central de Venezuela
name: Maria Montes de Oca, Internist - Pulmonologist
role: STUDY_CHAIR
References:
citation: 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.