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Determinants of Onset and Progression of COPD in Young Adults (EARLY COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
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
Hospital Parc Taulí, Sabadell
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
Information provided by (Responsible Party):
Borja Cosio, Hospital Son Espases

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.


Condition or disease
COPD

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Study Type : Observational
Actual Enrollment : 310 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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



Primary Outcome Measures :
  1. Differences in lung function measures between cases and controls [ Time Frame: At time of visit 1 (cross-sectional) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Smokers from 35 to 50 years who ever performed a spirometry in the selected primary care centers. Selected subjects will not have exacerbation symptoms (fever, new onset or increased cough, increase sputum volume and/or purulence, acute rhinitis) within 8 weeks prior to the recruitment (from beginning of the symptoms).
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 …

Information from the National Library of Medicine

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


Locations
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Spain
Hospital Son Espases
Palma Mallorca, Mallorca, Spain
Sponsors and Collaborators
Borja Cosio
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
Hospital Parc Taulí, Sabadell
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
Investigators
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Principal Investigator: Borja Cosio, Medical Doctor Spanish Research Center for Respiratory Diseases
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Responsible Party: Borja Cosio, Dr Fco. de Borja García-Cosío Piqueras, Hospital Son Espases
ClinicalTrials.gov Identifier: NCT02352220    
Other Study ID Numbers: PI13-02225
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018