Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2018-11-14
2019-01-21
Brief Summary
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Detailed Description
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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
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Study Design
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OTHER
PROSPECTIVE
Interventions
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PUMA Score questionnaire
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
40 Years
90 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Gustavo Zabert, MD
INDUSTRY
Responsible Party
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Gustavo Zabert, MD
Professor, MD
Principal Investigators
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Gustavo E Zabert, MD
Role: PRINCIPAL_INVESTIGATOR
ALAT
Ignacio Zabert, MD
Role: STUDY_DIRECTOR
ALAT
Fabian Mariluan, MD
Role: STUDY_DIRECTOR
ALAT
Locations
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Sistema Integrado de Salud
Tandil, Buenos Aires, Argentina
Hospital Perrando
Resistencia, Chaco Province, Argentina
Hospital "V Sanguinetti"
Comodoro Rivadavia, Chubut Province, Argentina
CEPROSS
San Salvador, Entre Ríos Province, Argentina
Hospital Alfredo Metraux,
Maipú, Mendoza Province, Argentina
Countries
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Central Contacts
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Facility Contacts
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Damian Silva, MD
Role: primary
Pedro Grabre, MD
Role: primary
Daniel Carles, MD
Role: backup
Diego Goffredo, MD
Role: primary
Walter Mattarucco, MD
Role: primary
Alfredo Moran, MD
Role: primary
References
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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.
Menezes 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.
Caballero 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.
Echazarreta 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.
Sobrino 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.
Schiavi 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.
Bergna 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.
Laniado-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.
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.
Stanley 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.
Price 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.
Other Identifiers
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IPUMA002
Identifier Type: -
Identifier Source: org_study_id