PUMA Implementation 2

COPD Clinical Trial

— IPUMA2  

Official title:

BUSQUEDA ACTIVA DE CASOS DE EPOC EN EL PRIMER NIVEL DE ATENCION: USO DEL SCORE PUMA PARA TAMIZAJE DE EPOC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03713931
• Other study ID #: IPUMA002
• Status: Recruiting
• Start date: November 14, 2018
• Est. completion date: January 21, 2019

Study information

• Verified date: December 2018
• Source: Asociacion Latinoamericana de Torax
• Contact: Gustavo E Zabert, MD
• Phone: +5492994422470
• Email: gzabert[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 21, 2019
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Argentina	Hospital "V Sanguinetti"	Comodoro Rivadavia	Chubut
Argentina	Hospital Alfredo Metraux,	Maipú	Mendoza
Argentina	Hospital Perrando	Resistencia	Chaco
Argentina	CEPROSS	San Salvador	Entre Rios
Argentina	Sistema Integrado de Salud	Tandil	Buenos Aires

Sponsors (2)

Lead Sponsor	Collaborator
Gustavo Zabert, MD	AstraZeneca

Country where clinical trial is conducted

Argentina, 

References & Publications (11)

Bergna MA, García 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. Eu — View Citation

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 — View Citation

Caballero A, Torres-Duque CA, Jaramillo C, Bolívar 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. Epub 2007 — View Citation

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. 2018 May;54(5):260-269. doi: 10. — View Citation

Laniado-Laborin R, Rendón 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. — View Citation

López 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: 1 — View Citation

Menezes AM, Perez-Padilla R, Jardim JR, Muiño 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. 200 — View Citation

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. — View Citation

Schiavi E, Stirbulov R, Hernández 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. E — View Citation

Sobrino E, Irazola VE, Gutierrez L, Chen CS, Lanas F, Calandrelli M, Ponzo J, Mores N, Serón P, Lee A, He J, Rubinstein AL. Estimating prevalence of chronic obstructive pulmonary disease in the Southern Cone of Latin America: how different spirometric cri — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COPD prevalence	FEV1 / FVC post-BD <0.70	2 days
Secondary	PUMA = 5 prevalence	cases with PUMA´s score = 5	1 day