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Completed

NCT Number: NCT01493544

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Belen de Escobar, Buenos Aires, Argentina

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of participants with an affirmative response to specific categories on the PUMA questionnaire.

    Time frame: 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.

  2. FEV1 spirometry measures.

    Time frame: 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.

  3. SaO2 (Arterial Oxygen Saturation) - pulse oximetry.

    Time frame: 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.

  4. Number of participants with an affirmative response to specific categories on the Medical History Questionnaire (if applicable).

    Time frame: 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.

  5. FEV1/FVC spirometry measures.

    Time frame: 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.

  6. Heart rate (HR) - pulse oximetry.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: PUMA PROJECT

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 16, 2011
Registry last updated
Apr 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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