Determinants of Onset and Progression of COPD in Young Adults

NCT02352220 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 310

Last updated 2018-02-27

No results posted yet for this study

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
  • Boehringer Ingelheim

    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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02352220 on ClinicalTrials.gov