Determinants of Onset and Progression of COPD in Young Adults
NCT02352220 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 310
Last updated 2018-02-27
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.
Conditions
Sponsors & Collaborators
-
Spanish Research Center for Respiratory Diseases
collaborator OTHER -
Hospital Son Espases
collaborator OTHER -
Hospital Clinic of Barcelona
collaborator OTHER -
Hospital del Mar
collaborator OTHER -
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
collaborator OTHER -
Hospital Universitario 12 de Octubre
collaborator OTHER -
Parc Taulí Hospital Universitari
collaborator OTHER -
Hospitales Universitarios Virgen del Rocío
collaborator OTHER -
Hospital Universitari de Bellvitge
collaborator OTHER -
Hospital Arnau de Vilanova
collaborator OTHER -
Hospital Universitario Central de Asturias
collaborator OTHER -
University Hospital of the Nuestra Señora de Candelaria
collaborator OTHER -
University Hospital A Coruña
collaborator OTHER -
Barcelona Institute for Global Health
collaborator OTHER - collaborator INDUSTRY
-
Borja Cosio
lead OTHER
Principal Investigators
-
Borja Cosio, Medical Doctor · Spanish Research Center for Respiratory Diseases
Eligibility
- Min Age
- 35 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-01-31
- Primary Completion
- 2020-12-31
- Completion
- 2020-12-31
Countries
- Spain
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