Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT01122758
Status:
UNKNOWN
Last Update Posted:
2012-11-28
First Post:
2010-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chronic Obstructive Pulmonary Disease (COPD) History Assessment In SpaiN (CHAIN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D012907', 'term': 'Smoking'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'complete blood and serum samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-11-27', 'studyFirstSubmitDate': '2010-05-11', 'studyFirstSubmitQcDate': '2010-05-12', 'lastUpdatePostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To better determine COPD with a multidimensional assessment and the phenotypic progression of COPD', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': '- Progression of the disease by degree of severity. - Effect of treatment on disease progression and variability of response according to phenotypes. - Geographical differences. - The impact of exacerbations. - The importance of comorbidities and', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cohort', 'COPD', 'Natural history', 'Phenotyping', 'Smoking'], 'conditions': ['COPD']}, 'referencesModule': {'references': [{'pmid': '40447521', 'type': 'DERIVED', 'citation': "Casanova C, Gonzalez-Davila E, de Torres JP, Cabrera C, Cosio BG, O'Donnel DE, Martinez-Gonzalez C, Solanes I, Fuster A, Gotera C, Marin A, Amado C, Iscar M, Marin JM, Neder JA, Feu N, Soriano JB, Lopez-Campos JL, Divo M, Peces-Barba G, Celli BR. Lung Diffusing Capacity Improves the Prognostic Validity of the GOLD Spirometric Staging in COPD. Arch Bronconeumol. 2025 May 16:S0300-2896(25)00178-4. doi: 10.1016/j.arbres.2025.05.004. Online ahead of print. English, Spanish."}, {'pmid': '33878339', 'type': 'DERIVED', 'citation': 'Casanova C, Gonzalez-Davila E, Martinez-Gonzalez C, Cosio BG, Fuster A, Feu N, Solanes I, Cabrera C, Marin JM, Balcells E, Peces-Barba G, de Torres JP, Marin-Oto M, Calle M, Golpe R, Ojeda E, Divo M, Pinto-Plata V, Amado C, Lopez-Campos JL, Celli BR. Natural Course of the Diffusing Capacity of the Lungs for Carbon Monoxide in COPD: Importance of Sex. Chest. 2021 Aug;160(2):481-490. doi: 10.1016/j.chest.2021.03.069. Epub 2021 Apr 18.'}, {'pmid': '33541356', 'type': 'DERIVED', 'citation': 'Calle Rubio M, Rodriguez Hermosa JL, de Torres JP, Marin JM, Martinez-Gonzalez C, Fuster A, Cosio BG, Peces-Barba G, Solanes I, Feu-Collado N, Lopez-Campos JL, Casanova C; CHAIN Study Investigators. COPD Clinical Control: predictors and long-term follow-up of the CHAIN cohort. Respir Res. 2021 Feb 4;22(1):36. doi: 10.1186/s12931-021-01633-y.'}, {'pmid': '30170807', 'type': 'DERIVED', 'citation': 'Soriano JB, Hahsler M, Soriano C, Martinez C, de-Torres JP, Marin JM, de Lucas P, Cosio BG, Fuster A, Casanova C; CHAIN investigators. Temporal transitions in COPD severity stages within the GOLD 2017 classification system. Respir Med. 2018 Sep;142:81-85. doi: 10.1016/j.rmed.2018.07.019. Epub 2018 Aug 3.'}, {'pmid': '29476876', 'type': 'DERIVED', 'citation': 'Martinez-Gonzalez C, Casanova C, de-Torres JP, Marin JM, de Lucas P, Fuster A, Cosio BG, Calle M, Peces-Barba G, Solanes I, Aguero R, Feu-Collado N, Alfageme I, Romero Plaza A, Balcells E, de Diego A, Marin Royo M, Moreno A, Llunell Casanovas A, Galdiz JB, Golpe R, Lacarcel Bautista C, Cabrera C, Marin A, Soriano JB, Lopez-Campos JL; CHAIN Study Investigators. Changes and Clinical Consequences of Smoking Cessation in Patients With COPD: A Prospective Analysis From the CHAIN Cohort. Chest. 2018 Aug;154(2):274-285. doi: 10.1016/j.chest.2018.02.007. Epub 2018 Feb 22.'}, {'pmid': '26291753', 'type': 'DERIVED', 'citation': 'Cosio BG, Soriano JB, Lopez-Campos JL, Calle-Rubio M, Soler-Cataluna JJ, de-Torres JP, Marin JM, Martinez-Gonzalez C, de Lucas P, Mir I, Peces-Barba G, Feu-Collado N, Solanes I, Alfageme I, Casanova C; CHAIN Study. Defining the Asthma-COPD Overlap Syndrome in a COPD Cohort. Chest. 2016 Jan;149(1):45-52. doi: 10.1378/chest.15-1055. Epub 2016 Jan 6.'}, {'pmid': '25612228', 'type': 'DERIVED', 'citation': 'Casanova C, Marin JM, Martinez-Gonzalez C, de Lucas-Ramos P, Mir-Viladrich I, Cosio B, Peces-Barba G, Solanes-Garcia I, Aguero R, Feu-Collado N, Calle-Rubio M, Alfageme I, de Diego-Damia A, Irigaray R, Marin M, Balcells E, Llunell A, Galdiz JB, Golpe R, Lacarcel C, Cabrera C, Marin A, Soriano JB, Lopez-Campos JL, Soler-Cataluna JJ, de-Torres JP; COPD History Assessment in Spain (CHAIN) Cohort. Differential Effect of Modified Medical Research Council Dyspnea, COPD Assessment Test, and Clinical COPD Questionnaire for Symptoms Evaluation Within the New GOLD Staging and Mortality in COPD. Chest. 2015 Jul;148(1):159-168. doi: 10.1378/chest.14-2449.'}, {'pmid': '24522636', 'type': 'DERIVED', 'citation': 'de Torres JP, Marin JM, Martinez-Gonzalez C, de Lucas-Ramos P, Mir-Viladrich I, Cosio B, Peces-Barba G, Calle-Rubio M, Solanes-Garcia I, Aguero Balbin R, de Diego-Damia A, Feu-Collado N, Alfageme Michavila I, Irigaray R, Balcells E, Llunell Casanovas A, Galdiz Iturri JB, Marin Royo M, Soler-Cataluna JJ, Lopez-Campos JL, Soriano JB, Casanova C; COPD History Assessment in Spain (CHAIN) Cohort*. Clinical application of the COPD assessment test: longitudinal data from the COPD History Assessment in Spain (CHAIN) cohort. Chest. 2014 Jul;146(1):111-122. doi: 10.1378/chest.13-2246.'}], 'seeAlsoLinks': [{'url': 'http://www.separ.es', 'label': 'SEPAR-Sociedad Española de Neumología y Cirugía Torácica'}]}, 'descriptionModule': {'briefSummary': 'The research project CHAIN (COPD Assessment History in Spain): "A Multidimensional Study on the Evolution of Chronic Obstructive Pulmonary Disease (COPD)is a multicentre, observational study conducted in several areas of Spain aimed to better define COPD natural history and its phenotypes', 'detailedDescription': 'Observational studies are needed to ascertain the natural history and progression of COPD, and to better define its phenotypes. These two aspects are considered fundamental to a proper evaluation of current (and future) COPD treatment options, and it could possibly justify the limited impact of recent major drug trials.\n\nCurrently, there remain gaps in the natural history of patients with COPD. Most data are from analysis of mild COPD patients or smokers, usually measuring only fall in FEV1, and both have significant limitations in design and interpretation.\n\nStudies in more severe patients with COPD have also been conducted mainly by studying lung function, possibly influenced by the recommendations of current guidelines for disease management. In recent years, we have more longitudinal data on changes in exercise capacity, imaging, and biomarkers, among other variables of interest, but our knowledge is yet partial.\n\nThe research project CHAIN (COPD Assessment History in Spain): "A Multidimensional Study on the Evolution of Chronic Obstructive Pulmonary Disease (COPD) is a multicenter observational study that will follow prospectively two cohorts: a) a COPD group active or former smokers (COPD cohort) and b) a group of active smokers or former smokers without COPD (control cohort). Both cohorts will be followed up for a period of at least 5 years, with visits every 12 months (and phone controls at least every 6 months). We will try to extend the monitoring of the cohort up to 10 years. CHAIN is supported by the PII of COPD SEPAR'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be selected from the outpatient clinics, pulmonary function labs, and / or pulmonology wards of each participating center', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 35 years.\n* Diagnosis of COPD (GOLD PBD FEV1/FVC ratio \\<0.70).\n* Being in a stable phase of disease (8 weeks without exacerbation).\n* Cummulative smoking ≥ 10 pack-years.\n* Absence of asthma or other chronic respiratory disease that justify the ventilatory disorder (although a history of asthma is not an exclusion criteria);\n* Absence of malignancy or very serious comorbidities that would prevent study completion.\n\nExclusion Criteria:\n\n* Patients \\<35 years.\n* Recent exacerbation (\\<8 weeks).\n* Not giving written informed consent.\n* Presence of asthma or other chronic respiratory disease justifying the ventilatory disorder,\n* Diffuse bronchiectasis not associated with COPD.\n* Presence of malignancy or very serious comorbidities that would prevent study completion.\n* Difficulty to perform appropriate follow-up.'}, 'identificationModule': {'nctId': 'NCT01122758', 'acronym': 'CHAIN', 'briefTitle': 'Chronic Obstructive Pulmonary Disease (COPD) History Assessment In SpaiN (CHAIN)', 'organization': {'class': 'NETWORK', 'fullName': 'Cimera'}, 'officialTitle': '(COPD History Assessment In SpaiN): "Estudio Sobre la Evolución Multidimensional de la Enfermedad Pulmonar Obstructiva Crónica (EPOC)".', 'orgStudyIdInfo': {'id': 'CHAIN'}, 'secondaryIdInfos': [{'id': 'IB1323/10PI', 'type': 'OTHER', 'domain': 'CEIC Illes Balears'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD cohort', 'description': 'Inclusion criteria:\n\n* Patients ≥ 35 years.\n* Diagnosis of COPD (GOLD PBD FEV1/FVC ratio \\<0.70).\n* Being in a stable phase of disease (8 weeks without exacerbation).\n* Cummulative smoking ≥ 10 pack-years.\n* Absence of asthma or other chronic respiratory disease that justify the ventilatory disorder (although a history of asthma is not an exclusion criteria);\n* Absence of malignancy or very serious comorbidities that would prevent study completion.\n\nExclusion criteria:\n\n* Patients \\<35 years.\n* Recent exacerbation (\\<8 weeks).\n* Not giving written informed consent.\n* Presence of asthma or other chronic respiratory disease justifying the ventilatory disorder,\n* Diffuse bronchiectasis not associated with COPD.\n* Presence of malignancy or very serious comorbidities that would prevent study completion.\n* Difficulty to perform appropriate follow-up.'}, {'label': 'Control cohort', 'description': 'Inclusion criteria:\n\n* Patients ≥ 35 years.\n* Absence of diagnosis of COPD (GOLD PBD FEV1/FVC ratio \\>=0.70).\n* Cummulative smoking ≥ 10 pack-years.\n* Absence of asthma or other chronic respiratory disease that justify the ventilatory disorder (although a history of asthma is not an exclusion criteria);\n* Absence of malignancy or very serious comorbidities that would prevent study completion.\n\nExclusion criteria:\n\n* Patients \\<35 years.\n* Not giving written informed consent.\n* Presence of asthma or other chronic respiratory disease justifying the ventilatory disorder,\n* Diffuse bronchiectasis not associated with COPD.\n* Presence of malignancy or very serious comorbidities that would prevent study completion.\n* Difficulty to perform appropriate follow-up.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santa Cruz de Tenerife', 'state': 'Canary Islands', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ciro Casanova', 'role': 'CONTACT', 'email': 'casanovaciro@gmail.com'}], 'facility': 'Ciro Casanova', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'zip': '07110', 'city': 'Bunyola', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Joan B Soriano, 724', 'role': 'CONTACT', 'email': 'jbsoriano@caubet-cimera.es', 'phone': '34971148437'}, {'name': '724 724 724, 724', 'role': 'CONTACT', 'email': 'jbsoriano@caubet-cimera.es', 'phone': '34971148437'}], 'facility': '40-50 additional centres throughout Spain', 'geoPoint': {'lat': 39.69634, 'lon': 2.69955}}], 'centralContacts': [{'name': 'Ciro Casanova, MD', 'role': 'CONTACT', 'email': 'casanovaciro@gmail.com'}, {'name': 'Joan B Soriano, MD', 'role': 'CONTACT', 'email': 'jbsoriano@caubet-cimera.es', 'phone': '34971148437'}], 'overallOfficials': [{'name': 'Ciro Casanova, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Nuestra Señora de la Candelaria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cimera', 'class': 'NETWORK'}, 'responsibleParty': {'oldNameTitle': 'Dr Ciro Casanova', 'oldOrganization': 'Hospital Universitario Nuestra Señora de la Candelaria'}}}}