COPD
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Spanish Research Center for Respiratory Diseases
Hospital Son Espases
Hospital Clinic of Barcelona
Hospital del Mar
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Hospital Universitario 12 de Octubre
Parc Taulí Hospital Universitari
Hospitales Universitarios Virgen del Rocío
Hospital Universitari de Bellvitge
Hospital Arnau de Vilanova
Hospital Universitario Central de Asturias
University Hospital of the Nuestra Señora de Candelaria
University Hospital A Coruña
Barcelona Institute for Global Health
Boehringer Ingelheim
Borja Cosio
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
35 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
\*\*Inclusion Criteria: COPD case: * Subjects between 35 and 50 years * Post-bronchodilator spirometry with FEV1/FVC \<70% * Smoker or ex-smoker with total cumulative exposure \> 10 pack-years Smoking control: * Subjects between 35 and 50 years * Post-bronchodilator spirometry with FEV1/FVC \>=70% * Smoker or ex-smoker with total cumulative exposure\> 10 pack-years *
Exclusion criteria
For cases: * Chronic inflammatory diseases including autoimmune diseases under treatment. * HIV * Active cancer * Cystic or saccular bronchiectasis * Conditions that may interfere with follow-up: frequent change of residence, psychiatric disorders, dementia… For controls: * Chronic inflammatory diseases including autoimmune diseases under treatment * HIV * Active cancer * Chronic respiratory diseases: * active tuberculosis * interstitial lung diseases * cystic or saccular bronchiectasis * ever diagnosed asthma * deficit of alpha1-antitrypsin * Conditions that may interfere with follow-up: frequent change of residence, psychiatric disorders, dementia …
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in lung function measures between cases and controls | At time of visit 1 (cross-sectional) |
Countries
Spain
Outcome results
None listed