Prevalence Study and Regular Practice Among General Practitioners in Populations at Risk of Chronic Obstructive Pulmonary Disease (COPD) in Latin America (PUMA PROJECT)
2013年4月25日 更新者：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.
研究概览
地位
完全的
条件
详细说明
PREVALENCE STUDY AND REGULAR PRACTICE (DIAGNOSIS AND TREATMENT) AMONG GENERAL PRACTICIONERS IN POPULATIONS AT RISK OF COPD IN LATIN AMERICA
研究类型
观察性的
注册 (实际的)
1907
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Montevideo、乌拉圭
- Research Site
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Antioquia
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Medellin、Antioquia、哥伦比亚
- Research Site
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Atlantico
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Barranquilla、Atlantico、哥伦比亚
- Research Site
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Caldas
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Manizales、Caldas、哥伦比亚
- Research Site
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Quindio
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Armenia、Quindio、哥伦比亚
- Research Site
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Valle Del Cauca
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Cali、Valle Del Cauca、哥伦比亚
- Research Site
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Barquisimeto、委内瑞拉
- Research Site
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Caracas、委内瑞拉
- Research Site
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Maracaibo、委内瑞拉
- Research Site
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Porlamar、委内瑞拉
- Research Site
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Valencia、委内瑞拉
- Research Site
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Capital Federal、阿根廷
- Research Site
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Buenos Aires
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Escobar、Buenos Aires、阿根廷
- Research Site
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Ezeiza、Buenos Aires、阿根廷
- Research Site
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Los Polvorines、Buenos Aires、阿根廷
- Research Site
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Martinez、Buenos Aires、阿根廷
- Research Site
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Quilmes、Buenos Aires、阿根廷
- Research Site
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Ramos Mejia、Buenos Aires、阿根廷
- Research Site
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients aged 40 or more, smokers or former smokers and/or people exposed to biomass combustion, who attend primary care consultation.
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Number of participants with an affirmative response to specific categories on the PUMA questionnaire.
大体时间：Baseline
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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.
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Baseline
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FEV1 spirometry measures.
大体时间：Baseline and visit 2 up to 4 weeks after baseline (if applicable)
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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.
大体时间：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).
大体时间：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.
大体时间：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.
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 学习椅：Maria Montes de Oca, Internist - Pulmonologist、Universidad Central de Venezuela
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年2月1日
初级完成 (实际的)
2012年10月1日
研究完成 (实际的)
2012年10月1日
研究注册日期
首次提交
2011年12月12日
首先提交符合 QC 标准的
2011年12月15日
首次发布 (估计)
2011年12月16日
研究记录更新
最后更新发布 (估计)
2013年4月26日
上次提交的符合 QC 标准的更新
2013年4月25日
最后验证
2013年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.