Prevalence Study and Regular Practice Among General Practitioners in Populations at Risk of Chronic Obstructive Pulmonary Disease (COPD) in Latin America (PUMA PROJECT)
25 april 2013 uppdaterad av: AstraZeneca
Prevalence Study and Regular Practice (Diagnosis and Treatment) Among General Practitioners in Populations at Risk of COPD in Latin America
PUMA is an observational, multicentre, multinational, cross-sectional study with primary care physicians (primary care, general and family physicians).
Participants will be selected sequentially among patients at risk for Chronic Obstructive Pulmonary Disease (COPD) who attend primary care consultation (primary care, general and family physicians).
The inclusion visit will be a regularly scheduled or spontaneous consultation for patients, and this appointment with the physician will not depend on the study.
During the appointment, data will be collected from the patient and the physician.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
PREVALENCE STUDY AND REGULAR PRACTICE (DIAGNOSIS AND TREATMENT) AMONG GENERAL PRACTICIONERS IN POPULATIONS AT RISK OF COPD IN LATIN AMERICA
Studietyp
Observationell
Inskrivning (Faktisk)
1907
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Capital Federal, Argentina
- Research Site
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Buenos Aires
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Escobar, Buenos Aires, Argentina
- Research Site
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Ezeiza, Buenos Aires, Argentina
- Research Site
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Los Polvorines, Buenos Aires, Argentina
- Research Site
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Martinez, Buenos Aires, Argentina
- Research Site
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Quilmes, Buenos Aires, Argentina
- Research Site
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Ramos Mejia, Buenos Aires, Argentina
- Research Site
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Antioquia
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Medellin, Antioquia, Colombia
- Research Site
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Atlantico
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Barranquilla, Atlantico, Colombia
- Research Site
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Caldas
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Manizales, Caldas, Colombia
- Research Site
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Quindio
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Armenia, Quindio, Colombia
- Research Site
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Valle Del Cauca
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Cali, Valle Del Cauca, Colombia
- Research Site
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Montevideo, Uruguay
- Research Site
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Barquisimeto, Venezuela
- Research Site
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Caracas, Venezuela
- Research Site
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Maracaibo, Venezuela
- Research Site
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Porlamar, Venezuela
- Research Site
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Valencia, Venezuela
- Research Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Patients aged 40 or more, smokers or former smokers and/or people exposed to biomass combustion, who attend primary care consultation.
Beskrivning
Inclusion Criteria:
- Men or women aged more or equal than 40
- Current or former smokers and/or patients exposed to biomass combustion:
Cigarettes: more or equal than 10 packs/year; Pipes: more or equal than 50 pipes/year; Cigars: more or equal than 50 cigars/year; Combustion: more or equal 100 hours/firewood/year
Exclusion Criteria:
- Pregnancy
- Patients with contraindications for spirometry
- Physical or mental disability rendering the patient unable to undergo a spirometry test and to contribute data to the study
- Heart rate ≥ 120 beats by minute
- Patients currently undergoing treatment for tuberculosis
- A patient who is participating in an interventional clinical trial or was previously included in this study
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of participants with an affirmative response to specific categories on the PUMA questionnaire.
Tidsram: Baseline
|
PUMA Questionnaire: Based on the PLATINO questionnaire.
Applied to patients to describe different aspects potentially related to Chronic Obstructive Pulmonary Disease (COPD) such as: respiratory symptoms, smoking, respiratory medication, health care resources usage, comorbidieties, etc., as well as the registration of procedures (spirometry and oximetry) carried out and anthropometric data.
|
Baseline
|
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FEV1 spirometry measures.
Tidsram: Baseline and visit 2 up to 4 weeks after baseline (if applicable)
|
FEV1 is the volume of air expelled from the lungs in 1 second. The second visit will be scheduled only for those patients who do not meet criteria for deferring spirometry. |
Baseline and visit 2 up to 4 weeks after baseline (if applicable)
|
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SaO2 (Arterial Oxygen Saturation) - pulse oximetry.
Tidsram: Baseline and visit 2 up to 4 weeks after baseline (if applicable)
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The second visit will be scheduled only for those patients who do not meet criteria for deferring spirometry.
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Baseline and visit 2 up to 4 weeks after baseline (if applicable)
|
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Number of participants with an affirmative response to specific categories on the Medical History Questionnaire (if applicable).
Tidsram: Baseline
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Questionnaire based on the patient's personal medical history at the site.
Its application will be subject to the existence of a prior medical history for the patient at site.
If the patient has no prior medical history at site, then this questionnaire will not apply.
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Baseline
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FEV1/FVC spirometry measures.
Tidsram: Baseline and visit 2 up to 4 weeks after baseline (if applicable)
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Ratio of Forced Expiratory Volume in 1 second (volume of air expelled from the lungs in 1 second) by the Forced Vital Capacity (FVC, the volume of air that can forcibly be blown out after full inspiration) is a spirometric measure (lung function test) used to demonstrate airway obstruction. The second visit will be scheduled only for those patients who do not meet criteria for deferring spirometry. |
Baseline and visit 2 up to 4 weeks after baseline (if applicable)
|
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Heart rate (HR) - pulse oximetry.
Tidsram: Baseline and visit 2 up to 4 weeks after baseline (if applicable)
|
The second visit will be scheduled only for those patients who do not meet criteria for deferring spirometry.
|
Baseline and visit 2 up to 4 weeks after baseline (if applicable)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: Maria Montes de Oca, Internist - Pulmonologist, Universidad Central de Venezuela
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2012
Primärt slutförande (Faktisk)
1 oktober 2012
Avslutad studie (Faktisk)
1 oktober 2012
Studieregistreringsdatum
Först inskickad
12 december 2011
Först inskickad som uppfyllde QC-kriterierna
15 december 2011
Första postat (Uppskatta)
16 december 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
26 april 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 april 2013
Senast verifierad
1 april 2013
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NIS-RLA-XXX-2011/1
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .