AdultIPUMA2NCT03713931
PUMA Implementation 2
An observational study of Adult and Risk Factors, run by Gustavo Zabert, MD at 5 sites in Argentina.
Trial summary
COPD is underdiagnosed and spirometry is not widely available in primary care settings. This study explore the value of PUMA´s questionnaire in a case finding strategy to detect patients to perform spirometry in a real world scenario of primary care health venues. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Adult, Risk Factors, Primary Care
- What is being tested?
- PUMA Score questionnaire
- How many people
- 1,000 participants
- Where
- 5 sitesArgentina
- Study dates
- 14 Nov 2018to 21 Jan 2019
- How long will I take part?
- 1 Month
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population for this active case finding study will be patients older than 40 years old, smokers or ever-smokers of more than 10 pack-years, who attend to the first level of care in the real world scenario of primary care facilities (for example: community hospital, university institutions or other environments) without respiratory specialists.
Who may be able to join
- Outpatients who attend the first level of care for any reason in usual care
- Informed consent: subjects must give their signed and dated informed consent to participate.
- Age older 40 years of age
- Smoker or ex-smoker of more than 10 years package
Who cannot join
- pregnancy,
- patients with contraindication for spirometry (thoracic, abdominal or neurological surgery,
- acute coronary syndrome, retinal detachment, hospitalization for any cardiac problem in the last 3 months)
- patients who at the time of performing the spirometry heart rate ≥ 120 bpm,
- patients with physical or mental incapacity to answer the questionnaire
- patients with physical or mental disability complete the study procedures,
- patients being treated for tuberculosis or any other infectious respiratory disease
- current participants of a clinical trial.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Argentina5 sites, 5 recruiting
- Recruiting
Hospital "V Sanguinetti"
Comodoro Rivadavia, Chubut Province, 9000
Diego Goffredo, MD, +5492974161910, diegoffre@hotmail.com
Diego Goffredo, MD
- Recruiting
Hospital Alfredo Metraux,
Maipu, Mendoza Province, 5569
Alfredo Moran, MD, +5492615435230, alfredomorandoc@hotmail.com
Alfredo Moran, MD
- Recruiting
Hospital Perrando
Resistencia, Chaco Province, 3500
Pedro Grabre, MD, +5493624599052, pedrogragbre@hotmail.com
Daniel Carles, MD, +5493624669957, selracdaniel@yahoo.com.ar
- Recruiting
CEPROSS
San Salvador, Entre Ríos Province, 3218
Walter Mattarucco, MD, +5491154856437, waltermattarucco@gmail.com
Walter Mattarucco, MD
- Recruiting
Sistema Integrado de Salud
Tandil, Buenos Aires, 7000
Damian Silva, MD, +5492494496783, damiansilva2012@gmail.com
Damian Silva, MD
About this study
Official title: BUSQUEDA ACTIVA DE CASOS DE EPOC EN EL PRIMER NIVEL DE ATENCION: USO DEL SCORE PUMA PARA TAMIZAJE DE EPOC
COPD is underdiagnosed and spirometry is not widely available in primary care settings. This study explore the value of PUMA´s questionnaire in a case finding strategy to detect patients to perform spirometry in a real world scenario of primary care health venues.
Read the detailed description
PUMA (Prevalence StUdy and Regular Practice, Diagnosis and TreatMent, Among General Practitioners in Populations at Risk of COPD in Latin America) study, a multicenter, multinational, cross-sectional, non-interventionist study, explored COPD prevalence among high risk patients assisted in primary care centers in 4 Latin American countries High risk condition was defined if the patient was older than 40 years and current or former smokers (≥10 pack-years, ≥50 pipes/year, or ≥50 cigars/year), and/or reported exposure to biomass smoke, such as wood or coal, for cooking or heating (exposure ≥100h/year). Patients were enrolled during routine, spontaneous or scheduled visits to their medical appointment neither related with the study nor respiratory services or specialists as well. COPD was defined as post-bronchodilator (post-BD) forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) <0.70 and the lower limit of normal (LLN) of FEV1/FVC.
Based on PUMA study data, a simple and a weighted score was constructed with seven variables: sex, age, pack-years smoking, dyspnea, sputum, cough and previous spirometry selected from the PLATINO questionnaire. The score had a mean accuracy for detecting COPD (post-BD FEV1/FVC <0.70) for high risk population of 76% and 79% for the simple and weighted scores, respectively.
This study is a prospective case finding study based on PUMA score as screening tool in unselected high risk patients attending to a primary care health care venue in real world scenario (e.g. community hospital, university institutions or other primary care settings). Patients older than 40 years of age and ever smoker of at least 10 pack year will be asked to complete the PUMA questionnaire through an specially designed application and electronic database (RedCap). All patients who with PUMA score ≥ 5, will be referred to perform spirometry at the institution.
Recruitment will be done by primary care physicians during regular consultations for any reason and spirometry will be performed by qualified technicians using the EasyOne® (nnd) spirometer. The quality of the spirometry will be evaluated by the central team that may request a second measurement to satisfy quality.
COPD will be diagnosed with fixed FEV1/FVC ratio (forced expiratory volume in the first second or FEV1 divided by forced vital capacity or FVC) less than 0.7.
Results will be reported to the primary care doctor and the patient
- Conditions
- Adult, Risk Factors, Primary Care, COPD, Screening Score, Spirometry
- Being tested
- PUMA Score questionnaire
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUMA Score questionnaireDiagnostic test
Also called Spirometry
Every patient who meet the criteria for active search (older than 40 years, smokers or ex-smokers of more than 10 pack-years who attend the usual care in the first level of care) will be scored with the PUMA´s questionnaire in an application and electronic database (RedCap) specially designed for the active search of cases.
Patients with PUMA´s score ≥ 5, and without exclusion criteria for spirometry will be referred to perform spirometry at the institution
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD prevalence
FEV1 / FVC post-BD <0.70
Measured: 2 days
Secondary outcomes (1)
PUMA ≥ 5 prevalence
cases with PUMA´s score ≥ 5
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start14 Nov 2018
- Primary completion21 Dec 2018 (estimated)
- Study completion21 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AdultStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Gustavo Zabert, MD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Gustavo Zabert, MD, Asociacion Latinoamericana de Torax
- Investigators
- Gustavo E Zabert, MD, Principal investigator, ALATIgnacio Zabert, MD, Study director, ALATFabian Mariluan, MD, Study director, ALAT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713931
- Sponsor's protocol ID
- IPUMA002
- Acronym
- IPUMA2
- Status last verified
- Dec 2018
- First submitted
- 18 Oct 2018
- Last updated
- 27 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Questionnaire and spirometric data will be available for review and analysis
Publications
Buist AS, McBurnie MA, Vollmer WM, Gillespie S, Burney P, Mannino DM, Menezes AM, Sullivan SD, Lee TA, Weiss KB, Jensen RL, Marks GB, Gulsvik A, Nizankowska-Mogilnicka E; BOLD Collaborative Research Group. International variation in the prevalence of COPD (the BOLD Study): a population-based prevalence study. Lancet. 2007 Sep 1;370(9589):741-50. doi: 10.1016/S0140-6736(07)61377-4.
PubMed 17765523Menezes AM, Perez-Padilla R, Jardim JR, Muino A, Lopez MV, Valdivia G, Montes de Oca M, Talamo C, Hallal PC, Victora CG; PLATINO Team. Chronic obstructive pulmonary disease in five Latin American cities (the PLATINO study): a prevalence study. Lancet. 2005 Nov 26;366(9500):1875-81. doi: 10.1016/S0140-6736(05)67632-5.
PubMed 16310554Caballero A, Torres-Duque CA, Jaramillo C, Bolivar F, Sanabria F, Osorio P, Orduz C, Guevara DP, Maldonado D. Prevalence of COPD in five Colombian cities situated at low, medium, and high altitude (PREPOCOL study). Chest. 2008 Feb;133(2):343-9. doi: 10.1378/chest.07-1361. Epub 2007 Oct 20.
PubMed 17951621Echazarreta AL, Arias SJ, Del Olmo R, Giugno ER, Colodenco FD, Arce SC, Bossio JC, Armando G, Soriano JB; Grupo de estudio EPOC.AR. Prevalence of COPD in 6 Urban Clusters in Argentina: The EPOC.AR Study. Arch Bronconeumol (Engl Ed). 2018 May;54(5):260-269. doi: 10.1016/j.arbres.2017.09.018. Epub 2017 Dec 6. English, Spanish.
PubMed 29221827Sobrino E, Irazola VE, Gutierrez L, Chen CS, Lanas F, Calandrelli M, Ponzo J, Mores N, Seron P, Lee A, He J, Rubinstein AL. Estimating prevalence of chronic obstructive pulmonary disease in the Southern Cone of Latin America: how different spirometric criteria may affect disease burden and health policies. BMC Pulm Med. 2017 Dec 11;17(1):187. doi: 10.1186/s12890-017-0537-9.
PubMed 29228947Schiavi E, Stirbulov R, Hernandez Vecino R, Mercurio S, Di Boscio V; Puma Team. COPD screening in primary care in four Latin American countries: methodology of the PUMA Study. Arch Bronconeumol. 2014 Nov;50(11):469-74. doi: 10.1016/j.arbres.2014.03.006. Epub 2014 May 9. English, Spanish.
PubMed 24816036Bergna MA, Garcia GR, Alchapar R, Altieri H, Casas JC, Larrateguy L, Nannini LJ, Pascansky D, Grabre P, Zabert G, Miravitlles M. Development of a simple binary response questionnaire to identify airflow obstruction in a smoking population in Argentina. Eur Respir Rev. 2015 Jun;24(136):320-6. doi: 10.1183/16000617.00005214.
PubMed 26028643Laniado-Laborin R, Rendon A, Bauerle O. Chronic obstructive pulmonary disease case finding in Mexico in an at-risk population. Int J Tuberc Lung Dis. 2011 Jun;15(6):818-23. doi: 10.5588/ijtld.10.0546.
PubMed 21575305Lopez 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 27319305Stanley AJ, Hasan I, Crockett AJ, van Schayck OC, Zwar NA. Validation of the COPD Diagnostic Questionnaire in an Australian general practice cohort: a cross-sectional study. Prim Care Respir J. 2014 Mar;23(1):92-7. doi: 10.4104/pcrj.2014.00015.
PubMed 24570082Price DB, Tinkelman DG, Nordyke RJ, Isonaka S, Halbert RJ; COPD Questionnaire Study Group. Scoring system and clinical application of COPD diagnostic questionnaires. Chest. 2006 Jun;129(6):1531-9. doi: 10.1378/chest.129.6.1531.
PubMed 16778271
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BUSQUEDA ACTIVA DE CASOS DE EPOC EN EL PRIMER NIVEL DE ATENCION: USO DEL SCORE PUMA PARA TAMIZAJE DE EPOC
- ClinicalTrials.gov ID
- NCT03713931
- Acronym / sponsor ID
- IPUMA2 / IPUMA002
- Conditions
- Adult, Risk Factors, Primary Care, COPD, Screening Score, Spirometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Gustavo Zabert, MDIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 21 Dec 2018 (estimated)
- Study completion
- 21 Jan 2019 (estimated)
- First posted
- 22 Oct 2018 (actual)
- 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.
COPD is underdiagnosed and spirometry is not widely available in primary care settings. This study explore the value of PUMA´s questionnaire in a case finding strategy to detect patients to perform spirometry in a real world scenario of primary care health venues.
Detailed description
PUMA (Prevalence StUdy and Regular Practice, Diagnosis and TreatMent, Among General Practitioners in Populations at Risk of COPD in Latin America) study, a multicenter, multinational, cross-sectional, non-interventionist study, explored COPD prevalence among high risk patients assisted in primary care centers in 4 Latin American countries High risk condition was defined if the patient was older than 40 years and current or former smokers (≥10 pack-years, ≥50 pipes/year, or ≥50 cigars/year), and/or reported exposure to biomass smoke, such as wood or coal, for cooking or heating (exposure ≥100h/year). Patients were enrolled during routine, spontaneous or scheduled visits to their medical appointment neither related with the study nor respiratory services or specialists as well. COPD was defined as post-bronchodilator (post-BD) forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) <0.70 and the lower limit of normal (LLN) of FEV1/FVC.
Based on PUMA study data, a simple and a weighted score was constructed with seven variables: sex, age, pack-years smoking, dyspnea, sputum, cough and previous spirometry selected from the PLATINO questionnaire. The score had a mean accuracy for detecting COPD (post-BD FEV1/FVC <0.70) for high risk population of 76% and 79% for the simple and weighted scores, respectively.
This study is a prospective case finding study based on PUMA score as screening tool in unselected high risk patients attending to a primary care health care venue in real world scenario (e.g. community hospital, university institutions or other primary care settings). Patients older than 40 years of age and ever smoker of at least 10 pack year will be asked to complete the PUMA questionnaire through an specially designed application and electronic database (RedCap). All patients who with PUMA score ≥ 5, will be referred to perform spirometry at the institution.
Recruitment will be done by primary care physicians during regular consultations for any reason and spirometry will be performed by qualified technicians using the EasyOne® (nnd) spirometer. The quality of the spirometry will be evaluated by the central team that may request a second measurement to satisfy quality.
COPD will be diagnosed with fixed FEV1/FVC ratio (forced expiratory volume in the first second or FEV1 divided by forced vital capacity or FVC) less than 0.7.
Results will be reported to the primary care doctor and the patient
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population for this active case finding study will be patients older than 40 years old, smokers or ever-smokers of more than 10 pack-years, who attend to the first level of care in the real world scenario of primary care facilities (for example: community hospital, university institutions or other environments) without respiratory specialists.
Key inclusion criteria (4 listed)
- Outpatients who attend the first level of care for any reason in usual care
- Informed consent: subjects must give their signed and dated informed consent to participate.
- Age older 40 years of age
- Smoker or ex-smoker of more than 10 years package
Key exclusion criteria (8 listed)
- pregnancy,
- patients with contraindication for spirometry (thoracic, abdominal or neurological surgery,
- acute coronary syndrome, retinal detachment, hospitalization for any cardiac problem in the last 3 months)
- patients who at the time of performing the spirometry heart rate ≥ 120 bpm,
- patients with physical or mental incapacity to answer the questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PUMA Score questionnaireAlso: SpirometryEvery patient who meet the criteria for active search (older than 40 years, smokers or ex-smokers of more than 10 pack-years who attend the usual care in the first level of care) will be scored with the PUMA´s questionnaire in an application and electronic database (RedCap) specially designed for the active search of cases. Patients with PUMA´s score ≥ 5, and without exclusion criteria for spirometry will be referred to perform spirometry at the institution | Diagnostic test | – |
Primary outcome
COPD prevalence
Time frame: 2 days
FEV1 / FVC post-BD <0.70
1 secondary outcome
PUMA ≥ 5 prevalence
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2018.
- Results publication: PubMed 17765523Buist AS, McBurnie MA, Vollmer WM, Gillespie S, Burney P, Mannino DM, Menezes AM, Sullivan SD, Lee TA, Weiss KB, Jensen RL, Marks GB, Gulsvik A, Nizankowska-Mogilnicka E; BOLD Collaborative Research Group. International variation in the prevalence of COPD (the BOLD Study): a population-based prevalence study. Lancet. 2007 Sep 1;370(9589):741-50. doi: 10.1016/S0140-6736(07)61377-4.
- Results publication: PubMed 16310554Menezes AM, Perez-Padilla R, Jardim JR, Muino A, Lopez MV, Valdivia G, Montes de Oca M, Talamo C, Hallal PC, Victora CG; PLATINO Team. Chronic obstructive pulmonary disease in five Latin American cities (the PLATINO study): a prevalence study. Lancet. 2005 Nov 26;366(9500):1875-81. doi: 10.1016/S0140-6736(05)67632-5.
- Results publication: PubMed 17951621Caballero A, Torres-Duque CA, Jaramillo C, Bolivar F, Sanabria F, Osorio P, Orduz C, Guevara DP, Maldonado D. Prevalence of COPD in five Colombian cities situated at low, medium, and high altitude (PREPOCOL study). Chest. 2008 Feb;133(2):343-9. doi: 10.1378/chest.07-1361. Epub 2007 Oct 20.
- Results publication: PubMed 29221827Echazarreta AL, Arias SJ, Del Olmo R, Giugno ER, Colodenco FD, Arce SC, Bossio JC, Armando G, Soriano JB; Grupo de estudio EPOC.AR. Prevalence of COPD in 6 Urban Clusters in Argentina: The EPOC.AR Study. Arch Bronconeumol (Engl Ed). 2018 May;54(5):260-269. doi: 10.1016/j.arbres.2017.09.018. Epub 2017 Dec 6. English, Spanish.
- Results publication: PubMed 29228947Sobrino E, Irazola VE, Gutierrez L, Chen CS, Lanas F, Calandrelli M, Ponzo J, Mores N, Seron P, Lee A, He J, Rubinstein AL. Estimating prevalence of chronic obstructive pulmonary disease in the Southern Cone of Latin America: how different spirometric criteria may affect disease burden and health policies. BMC Pulm Med. 2017 Dec 11;17(1):187. doi: 10.1186/s12890-017-0537-9.
- Results publication: PubMed 24816036Schiavi E, Stirbulov R, Hernandez Vecino R, Mercurio S, Di Boscio V; Puma Team. COPD screening in primary care in four Latin American countries: methodology of the PUMA Study. Arch Bronconeumol. 2014 Nov;50(11):469-74. doi: 10.1016/j.arbres.2014.03.006. Epub 2014 May 9. English, Spanish.
- Results publication: PubMed 26028643Bergna MA, Garcia GR, Alchapar R, Altieri H, Casas JC, Larrateguy L, Nannini LJ, Pascansky D, Grabre P, Zabert G, Miravitlles M. Development of a simple binary response questionnaire to identify airflow obstruction in a smoking population in Argentina. Eur Respir Rev. 2015 Jun;24(136):320-6. doi: 10.1183/16000617.00005214.
- Results publication: PubMed 21575305Laniado-Laborin R, Rendon A, Bauerle O. Chronic obstructive pulmonary disease case finding in Mexico in an at-risk population. Int J Tuberc Lung Dis. 2011 Jun;15(6):818-23. doi: 10.5588/ijtld.10.0546.
- Results publication: 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.
- Results publication: PubMed 24570082Stanley AJ, Hasan I, Crockett AJ, van Schayck OC, Zwar NA. Validation of the COPD Diagnostic Questionnaire in an Australian general practice cohort: a cross-sectional study. Prim Care Respir J. 2014 Mar;23(1):92-7. doi: 10.4104/pcrj.2014.00015.
- Results publication: PubMed 16778271Price DB, Tinkelman DG, Nordyke RJ, Isonaka S, Halbert RJ; COPD Questionnaire Study Group. Scoring system and clinical application of COPD diagnostic questionnaires. Chest. 2006 Jun;129(6):1531-9. doi: 10.1378/chest.129.6.1531.
- Individual participant dataSharing planned: Yes. Questionnaire and spirometric data will be available for review and analysis
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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.
Gustavo E Zabert, MD principal investigator
ALAT
Ignacio Zabert, MD study director
ALAT
Fabian Mariluan, MD study director
ALAT
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult and Risk Factors, run by Gustavo Zabert, MD at 5 sites in Argentina.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 27 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Argentina. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gustavo E Zabert, MD (+5492994422470 ext. 175, gzabert@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD prevalence (time frame: 2 days). 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 NCT03713931, which also lists 11 linked publications.
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 27 Dec 2018.