PUMA Implementation 2

NCT03713931 | Unknown DMC

• 1 other identifier: IPUMA002
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Adult; Risk Factors; Primary Care; COPD; Screening Score; Spirometry; Diagnosis

Outcome Measures

Primary Outcomes (1)

• COPD prevalence

  FEV1 / FVC post-BD \<0.70

  2 days

Secondary Outcomes (1)

• PUMA ≥ 5 prevalence

  1 day

Interventions

PUMA Score questionnaire DIAGNOSTIC_TEST

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

Also known as: Spirometry

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gustavo Zabert, MD: lead
• AstraZeneca: collaborator

Study Sites (5)

Sistema Integrado de Salud

Tandil, Buenos Aires, 7000, Argentina

RECRUITING

Hospital Perrando

Resistencia, Chaco Province, 3500, Argentina

RECRUITING

Hospital "V Sanguinetti"

Comodoro Rivadavia, Chubut Province, 9000, Argentina

RECRUITING

CEPROSS

San Salvador, Entre Ríos Province, 3218, Argentina

RECRUITING

Hospital Alfredo Metraux,

Maipú, Mendoza Province, 5569, Argentina

RECRUITING

Related Publications (11)

• 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.

  PMID: 17765523 RESULT

• 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.

  PMID: 16310554 RESULT

• 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.

  PMID: 17951621 RESULT

• 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.

  PMID: 29221827 RESULT

• 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.

  PMID: 29228947 RESULT

• 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.

  PMID: 24816036 RESULT

• 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.

  PMID: 26028643 RESULT

• 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.

  PMID: 21575305 RESULT

• 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.

  PMID: 27319305 RESULT

• 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.

  PMID: 24570082 RESULT

• 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.

  PMID: 16778271 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Disease

Interventions

Spirometry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Gustavo E Zabert, MD

  ALAT

  PRINCIPAL INVESTIGATOR

• Ignacio Zabert, MD

  ALAT

  STUDY DIRECTOR

• Fabian Mariluan, MD

  ALAT

  STUDY DIRECTOR

Central Study Contacts

Gustavo E Zabert, MD

CONTACT

+5492994422470; gzabert@gmail.com

Ignacio E Zabert, MD

CONTACT

+5492994423254; izabert@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 22, 2018
• Study Start: November 14, 2018
• Primary Completion: December 21, 2018
• Study Completion: January 21, 2019
• Last Updated: December 27, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 6 month after last patient recruited
• Access Criteria: IPD will be shared with other research groups interested in similar initiatives. Information about proyect and responsable investigator/person will be requested. Each requests will be reviewed by PUMA 2 team and ALAT reserach board

Locations

AR (5)