PUMA Implementation 2

• Conditions: Adult; COPD; Spirometry; Primary Care; Diagnosis; Risk Factors; Screening Score

• Registration Number: NCT03713931
• Lead Sponsor: Gustavo Zabert, MD

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.

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 Timeline

• Study First Submitted: 2018-10-18
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-22
• Study Start: 2018-11-14
• Status Verified: 2018-12
• Primary Completion: 2018-12-21
• Last Update Submitted: 2018-12-26
• Last Update Posted: 2018-12-27
• Study Completion: 2019-01-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
COPD prevalence	2 days	FEV1 / FVC post-BD \<0.70

Secondary Outcome Measures

Name	Time	Method
PUMA ≥ 5 prevalence	1 day	cases with PUMA´s score ≥ 5

Trial Locations

Locations (5)

CEPROSS; 🇦🇷 San Salvador, Entre Rios, Argentina

Hospital Alfredo Metraux,; 🇦🇷 Maipú, Mendoza, Argentina

Hospital "V Sanguinetti"; 🇦🇷 Comodoro Rivadavia, Chubut, Argentina

Sistema Integrado de Salud; 🇦🇷 Tandil, Buenos Aires, Argentina

Hospital Perrando; 🇦🇷 Resistencia, Chaco, Argentina