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Clinical Trials/NCT02352220
NCT02352220
Unknown
Not Applicable

Early COPD: Determinants of Onset and Progression of COPD in Young Adults

Borja Cosio1 site in 1 country310 target enrollmentJanuary 2015
ConditionsCOPD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD
Sponsor
Borja Cosio
Enrollment
310
Locations
1
Primary Endpoint
Differences in lung function measures between cases and controls
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
December 2020
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Borja Cosio
Responsible Party
Sponsor Investigator
Principal Investigator

Borja Cosio

Dr Fco. de Borja García-Cosío Piqueras

Hospital Son Espases

Eligibility Criteria

Inclusion Criteria

  • 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

  • Chronic inflammatory diseases including autoimmune diseases under treatment.
  • 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
  • Active cancer
  • Chronic respiratory diseases:
  • active tuberculosis
  • interstitial lung diseases

Outcomes

Primary Outcomes

Differences in lung function measures between cases and controls

Time Frame: At time of visit 1 (cross-sectional)

Study Sites (1)

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