Determinants of Onset and Progression of COPD in Young Adults (EARLY COPD)
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|ClinicalTrials.gov Identifier: NCT02352220|
Recruitment Status : Unknown
Verified February 2018 by Borja Cosio, Hospital Son Espases.
Recruitment status was: Active, not recruiting
First Posted : February 2, 2015
Last Update Posted : February 27, 2018
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||310 participants|
|Official Title:||Early COPD: Determinants of Onset and Progression of COPD in Young Adults|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
- Differences in lung function measures between cases and controls [ Time Frame: At time of visit 1 (cross-sectional) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352220
|Hospital Son Espases|
|Palma Mallorca, Mallorca, Spain|
|Principal Investigator:||Borja Cosio, Medical Doctor||Spanish Research Center for Respiratory Diseases|