Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-02-25 @ 5:40 AM
Study NCT ID:
NCT02352220
Status:
UNKNOWN
Last Update Posted:
2018-02-27
First Post:
2014-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determinants of Onset and Progression of COPD in Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-24', 'studyFirstSubmitDate': '2014-12-02', 'studyFirstSubmitQcDate': '2015-01-27', 'lastUpdatePostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in lung function measures between cases and controls', 'timeFrame': 'At time of visit 1 (cross-sectional)'}]}, 'conditionsModule': {'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': "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.\n\nStudy 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.\n\nMethods: 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': True, 'eligibilityCriteria': '\\*\\*Inclusion Criteria:\n\nCOPD case:\n\n* Subjects between 35 and 50 years\n* Post-bronchodilator spirometry with FEV1/FVC \\<70%\n* Smoker or ex-smoker with total cumulative exposure \\> 10 pack-years\n\nSmoking control:\n\n* Subjects between 35 and 50 years\n* Post-bronchodilator spirometry with FEV1/FVC \\>=70%\n* Smoker or ex-smoker with total cumulative exposure\\> 10 pack-years\n\n * Exclusion Criteria:\n\nFor cases:\n\n* Chronic inflammatory diseases including autoimmune diseases under treatment.\n* HIV\n* Active cancer\n* Cystic or saccular bronchiectasis\n* Conditions that may interfere with follow-up: frequent change of residence, psychiatric disorders, dementia…\n\nFor controls:\n\n* Chronic inflammatory diseases including autoimmune diseases under treatment\n* HIV\n* Active cancer\n* Chronic respiratory diseases:\n* active tuberculosis\n* interstitial lung diseases\n* cystic or saccular bronchiectasis\n* ever diagnosed asthma\n* deficit of alpha1-antitrypsin\n* Conditions that may interfere with follow-up: frequent change of residence, psychiatric disorders, dementia …'}, 'identificationModule': {'nctId': 'NCT02352220', 'acronym': 'EARLY COPD', 'briefTitle': 'Determinants of Onset and Progression of COPD in Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Son Espases'}, 'officialTitle': 'Early COPD: Determinants of Onset and Progression of COPD in Young Adults', 'orgStudyIdInfo': {'id': 'PI13-02225'}}, 'contactsLocationsModule': {'locations': [{'city': 'Palma Mallorca', 'state': 'Mallorca', 'country': 'Spain', 'facility': 'Hospital Son Espases'}], 'overallOfficials': [{'name': 'Borja Cosio, Medical Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spanish Research Center for Respiratory Diseases'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Borja Cosio', 'class': 'OTHER'}, 'collaborators': [{'name': 'Spanish Research Center for Respiratory Diseases', 'class': 'OTHER'}, {'name': 'Hospital Son Espases', 'class': 'OTHER'}, {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, {'name': 'Hospital del Mar', 'class': 'OTHER'}, {'name': 'Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz', 'class': 'OTHER'}, {'name': 'Hospital Universitario 12 de Octubre', 'class': 'OTHER'}, {'name': 'Parc Taulí Hospital Universitari', 'class': 'OTHER'}, {'name': 'Hospitales Universitarios Virgen del Rocío', 'class': 'OTHER'}, {'name': 'Hospital Universitari de Bellvitge', 'class': 'OTHER'}, {'name': 'Hospital Arnau de Vilanova', 'class': 'OTHER'}, {'name': 'Hospital Universitario Central de Asturias', 'class': 'OTHER'}, {'name': 'University Hospital of the Nuestra Señora de Candelaria', 'class': 'OTHER'}, {'name': 'University Hospital A Coruña', 'class': 'OTHER'}, {'name': 'Barcelona Institute for Global Health', 'class': 'OTHER'}, {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr Fco. de Borja García-Cosío Piqueras', 'investigatorFullName': 'Borja Cosio', 'investigatorAffiliation': 'Hospital Son Espases'}}}}