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PUMA Implementation 2 (IPUMA2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03713931
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : December 27, 2018
Information provided by (Responsible Party):
Gustavo Zabert, MD, Asociacion Latinoamericana de Torax

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.

Condition or disease Intervention/treatment
Adult Risk Factors Primary Care COPD Screening Score Spirometry Diagnosis Diagnostic Test: PUMA Score questionnaire

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Actual Study Start Date : November 14, 2018
Estimated Primary Completion Date : December 21, 2018
Estimated Study Completion Date : January 21, 2019

Intervention Details:
  • 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

    Other Name: Spirometry

Primary Outcome Measures :
  1. COPD prevalence [ Time Frame: 2 days ]
    FEV1 / FVC post-BD <0.70

Secondary Outcome Measures :
  1. PUMA ≥ 5 prevalence [ Time Frame: 1 day ]
    cases with PUMA´s score ≥ 5

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03713931

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Contact: Gustavo E Zabert, MD +5492994422470 ext 175
Contact: Ignacio E Zabert, MD +5492994423254

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Sistema Integrado de Salud Recruiting
Tandil, Buenos Aires, Argentina, 7000
Contact: Damian Silva, MD    +5492494496783   
Principal Investigator: Damian Silva, MD         
Hospital Perrando Recruiting
Resistencia, Chaco, Argentina, 3500
Contact: Pedro Grabre, MD    +5493624599052   
Contact: Daniel Carles, MD    +5493624669957   
Principal Investigator: Pedro Grabre, MD         
Sub-Investigator: Daniel Grabre, MD         
Hospital "V Sanguinetti" Recruiting
Comodoro Rivadavia, Chubut, Argentina, 9000
Contact: Diego Goffredo, MD    +5492974161910   
Principal Investigator: Diego Goffredo, MD         
CEPROSS Recruiting
San Salvador, Entre Rios, Argentina, 3218
Contact: Walter Mattarucco, MD    +5491154856437   
Principal Investigator: Walter Mattarucco, MD         
Hospital Alfredo Metraux, Recruiting
Maipú, Mendoza, Argentina, 5569
Contact: Alfredo Moran, MD    +5492615435230   
Principal Investigator: Alfredo Moran, MD         
Sponsors and Collaborators
Gustavo Zabert, MD
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Principal Investigator: Gustavo E Zabert, MD ALAT
Study Director: Ignacio Zabert, MD ALAT
Study Director: Fabian Mariluan, MD ALAT

Additional Information:

Publications of Results:

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Responsible Party: Gustavo Zabert, MD, Professor, MD, Asociacion Latinoamericana de Torax Identifier: NCT03713931     History of Changes
Other Study ID Numbers: IPUMA002
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Questionnaire and spirometric data will be available for review and analysis
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No