COPD Clinical Trial
Official title:
Early COPD: Determinants of Onset and Progression of COPD in Young Adults
COPD (Chronic Obstructive Pulmonary Disease) is a Public Health problem due to its impact in
the patient's quality of life, high prevalence, growing incidence and socioeconomic
implication. COPD natural history and first stages determinants are unknown. Knowing them
will help to understand the natural history of the disease and to design interventions that
can modify the prognosis of the disease.
Study objectives: (1) To characterize an early COPD population from a multidimensional point
of view including demographic, social, family and clinical data, lung function, exercise
capacity, image, microbiology, quality of life, exacerbations, comorbidities and blood and
sputum biomarkers. (2) To compare this patients with smoking subjects, with normal lung
function, matched by age, sex and site. (3) To create an early COPD cohort to be followed in
the future to understand the complete natural history of the disease.
Methods: Design: multicenter cross-sectional study that will allow establishing a
well-characterized cohort of early COPD patients for later follow-up. Recruitment will be
done in Primary Care settings. Subjects: smokers (> 10 packs year) between 35-50 years old
with a spirometry (normal or obstructive) done in the last year. Diagnosis of COPD will be
based on the smoking history and a postbronchodilator test FEV1(Forced Expiratory Volume in
the first second) / FVC(Forced Vital Capacity) < 70%. Age, sex and site matched 'healthy'
smoker controls will be compared with the COPD cases. Variables that will be collected in the
reference hospitals are: health questionnaires, lung function test, exercise capacity, blood
and sputum samples, and low dose CT-scan. Statistical analysis: early COPD patient's
characteristics will be described and then, will be compared, with control subjects through a
conditional multiple logistic regression analysis.
n/a
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