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Vol. 45. Issue 1.
Pages 4-11 (January 2009)
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Vol. 45. Issue 1.
Pages 4-11 (January 2009)
Original Article
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Phenotypic Characterization and Course of Chronic Obstructive Pulmonary Disease in the PAC-COPD Study: Design and Methods
Caracterización fenotípica y evolución de la EPOC en el estudio PAC-COPD: diseño y metodología
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Judith Garcia-Aymericha,
Corresponding author
jgarcia@creal.cat

Corresponding author.
, Federico P. Gómezb, Josep M. Antóa, on behalf of the PAC-COPD research group
a Center for Research in Environmental Epidemiology (CREAL), Institut Municipal d’Investigació Mèdica-Hospital del Mar, Universitat Pompeu Fabra, CIBER de Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain
b Servei de Pneumologia, Institut del Tòrax, Hospital Clínic, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), CIBER de Enfermedades Respiratorias, Barcelona, Spain
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Abstract
Background and Objectives

The Phenotype and Course of Chronic Obstructive Pulmonary Disease (PAC-COPD) study aims to improve our understanding of the phenotypic heterogeneity of this disease and the extent to which this heterogeneity is related to clinical course. The main objectives are a) to characterize the phenotypic variability in first-time hospitalizations for exacerbation of COPD and to propose a classification into subtypes, and b) to ascertain the association between the defined subtypes and the clinical and functional course of COPD.

Patients and Methods

This is a cross-sectional and cohort study of 342 patients with COPD from 9 tertiary hospitals in 3 autonomous communities. The minimum follow-up period is 5 years. The main variables of interest are respiratory symptoms, smoking, alcohol use, physical activity, use of health care services, medical care, treatment received, activities of daily living, comorbid conditions, sleepiness, anxiety and depression, quality of life, forced spirometry and bronchodilator tests, lung volume and inspiratory capacity measured by body plethysmography, carbon monoxide diffusing capacity, baseline arterial blood gas values, respiratory and peripheral muscle function, electrocardiogram, body weight and composition measured by bioelectric impedance, chest radiograph, skin prick test, capacity for exercise measured in the 6-minute walk test and cardiopulmonary exercise test, induced sputum (for quantitative microbiological culture and determination of inflammatory markers), nighttime pulse oximetry, chest computed tomography scan, and echocardiography. Levels of markers of inflammation and oxidative stress are measured in serum and plasma; these samples are also used for genetic analysis and will be stored for other possible measurements that might be required in the future. The statistical analysis combines factor analysis and survival models such as Cox regression analysis. This project will enable us to reconsider the definition and classification of COPD and to better understand the factors associated with its natural history.

Keywords:
Epidemiology
Phenotype
COPD
Resumen
Introducción y objetivos

El estudio Caracterización Fenotípica y Evolución de la Enfermedad Pulmonar Obstructiva Crónica (PAC-COPD) pretende mejorar la comprensión de la heterogeneidad fenotípica de esta enfermedad y el grado en que dicha heterogeneidad se relaciona con su evolución. Los principales objetivos son: a) caracterizar la variabilidad fenotípica de las personas que ingresan por primera vez por agudización de la enfermedad pulmonar obstructiva crónica (EPOC) y proponer una clasificación en subtipos, y b) estimar la asociación entre los subtipos definidos y la evolución clínica y funcional de la EPOC.

Pacientes y método

El diseño de investigación incluye un estudio transversal y un estudio de seguimiento de una cohorte de 342 pacientes con EPOC procedentes de 9 hospitales terciarios de 3 comunidades autónomas. El período de seguimiento abarca un mínimo de 5 años. Las principales medidas que se determinarán son las siguientes: síntomas respiratorios, tabaco, alcohol, actividad física, utilización de servicios sanitarios, atención médica, tratamientos recibidos, actividades de la vida diaria, comorbilidades, somnolencia, ansiedad y depresión, calidad de vida, espirometría forzada y prueba broncodilatadora, pletismografía corporal con volúmenes pulmonares y capacidad inspiratoria, capacidad de transferencia del monóxido de carbono, gasometría arterial basal, función de músculos respiratorios y periféricos, electrocardiograma, peso y composición nutricional mediante impedanciometría bioeléctrica, radiografía de tórax, pruebas cutáneas de alergia, capacidad de ejercicio según la prueba de la marcha de 6 min y prueba de ejercicio cardiopulmonar, esputo inducido (para cultivo microbiológico cuantitativo y determinación de marcadores de inflamación), pulsioximetría nocturna, tomografía computarizada pulmonar y ecocardiografía. Además, se obtienen muestras de suero y plasma para la medición de marcadores inflamatorios y de estrés oxidativo, análisis genéticos y otras posibles mediciones que puedan plantearse en el futuro. Para el análisis estadístico de los resultados se combinará el análisis factorial con modelos de supervivencia como la regresión de Cox. El proyecto permitirá replantear la definición y clasificación de la EPOC, así como comprender mejor los factores asociados a su evolución.

Palabras clave:
Epidemiología
Fenotipo
EPOC
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