Chronic Obstructive Pulmonary DiseasePUMA PROJECTNCT01493544
Prevalence Study and Regular Practice Among General Practitioners in Populations at Risk of Chronic Obstructive Pulmonary Disease (COPD) in Latin America
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 18 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 1,907 participants
- Where
- 18 sitesin 4 countries
- Study dates
- Feb 2012to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 40 or more, smokers or former smokers and/or people exposed to biomass combustion, who attend primary care consultation.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
Argentina7 sites
Research Site
Belen de Escobar, Buenos Aires
Research Site
Capital Federal, Buenos Aires F.D.
Research Site
Ezeiza, Buenos Aires
Research Site
Los Polvorines, Buenos Aires
Research Site
Martínez, Buenos Aires
Research Site
Quilmes, Buenos Aires
Research Site
Ramos Mejía, Buenos Aires
Colombia5 sites
Research Site
Armenia, Quindío Department
Research Site
Barranquilla, Atlántico
Research Site
Cali, Valle del Cauca Department
Research Site
Manizales, Caldas Department
Research Site
Medellín, Antioquia
Venezuela5 sites
Research Site
Barquisimeto
Research Site
Caracas
Research Site
Maracaibo
Research Site
Porlamar
Research Site
Valencia
About this study
Official title: Prevalence Study and Regular Practice (Diagnosis and Treatment) Among General Practitioners in Populations at Risk of 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.
Read the detailed description
PREVALENCE STUDY AND REGULAR PRACTICE (DIAGNOSIS AND TREATMENT) AMONG GENERAL PRACTICIONERS IN POPULATIONS AT RISK OF COPD IN LATIN AMERICA
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, smokers, primary care
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Baseline and visit 2 up to 4 weeks after baseline (if applicable)
SaO2 (Arterial Oxygen Saturation) - pulse oximetry.
The second visit will be scheduled only for those patients who do not meet criteria for deferring spirometry.
Measured: Baseline and visit 2 up to 4 weeks after baseline (if applicable)
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.
Measured: Baseline
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.
Measured: Baseline and visit 2 up to 4 weeks after baseline (if applicable)
Heart rate (HR) - pulse oximetry.
The second visit will be scheduled only for those patients who do not meet criteria for deferring spirometry.
Measured: Baseline and visit 2 up to 4 weeks after baseline (if applicable)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startFeb 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,907 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Montes de Oca, Internist - Pulmonologist, Study chair, Universidad Central de Venezuela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493544
- Sponsor's protocol ID
- NIS-RLA-XXX-2011/1
- Acronym
- PUMA PROJECT
- Status last verified
- Apr 2013
- First submitted
- 12 Dec 2011
- Last updated
- 26 Apr 2013
- Results posted
- No
Publications
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.
PubMed 27319305
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence Study and Regular Practice (Diagnosis and Treatment) Among General Practitioners in Populations at Risk of COPD in Latin America
- ClinicalTrials.gov ID
- NCT01493544
- Acronym / sponsor ID
- PUMA PROJECT / NIS-RLA-XXX-2011/1
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, smokers, primary care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,907 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 16 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 40 or more, smokers or former smokers and/or people exposed to biomass combustion, who attend primary care consultation.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
- Derived from this study: PubMed 27319305Lopez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Montes de Oca, Internist - Pulmonologist study chair
Universidad Central de Venezuela
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 18 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Argentina, Colombia, Venezuela, Uruguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with an affirmative response to specific categories on the PUMA questionnaire. (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01493544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2013; AzTrials last refreshed its copy on 28 Oct 2026.