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

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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 |
**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%
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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 …

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
Spain | |
Hospital Son Espases | |
Palma Mallorca, Mallorca, Spain |
Principal Investigator: | Borja Cosio, Medical Doctor | Spanish Research Center for Respiratory Diseases |
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 |