Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-25 @ 2:12 PM
Study NCT ID:
NCT01485159
Status:
COMPLETED
Last Update Posted:
2014-02-24
First Post:
2011-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Airflow Limitation in Cardiac Diseases in Europe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004646', 'term': 'Emphysema'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D029481', 'term': 'Bronchitis, Chronic'}], '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': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'In patients that specifically consent, blood samples will be taken for future analysis of the genetic links between COPD and cardiovascular disease'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-20', 'studyFirstSubmitDate': '2011-11-17', 'studyFirstSubmitQcDate': '2011-12-01', 'lastUpdatePostDateStruct': {'date': '2014-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Airflow Limitation', 'timeFrame': '1 day', 'description': 'Prevalence of AL as defined by Forced Expired Volume in 1 second (FEV1)/Forced Volume Capacity (FVC) \\< 0.70 (post bronchodilator)'}], 'secondaryOutcomes': [{'measure': 'Severity of AL', 'timeFrame': '1 day', 'description': 'Severity of AL as determined by predicted FEV1 (post-bronchodilator) - mild: ≥80%, moderate: 50-80%, severe: 30-50%, very severe: \\<30%, or \\<50% plus chronic respiratory failure'}, {'measure': 'prevalence of restrictive AL', 'timeFrame': '1 day', 'description': 'Prevlence of restrictive AL FEV1/FVC ≥0.70 and a predicted FVC \\<80% (pre bronchodilator)'}, {'measure': 'Prevalence of AL', 'timeFrame': '1 day', 'description': 'Prevalence of AL as defined by FEV1 below the lower limit of normal'}, {'measure': 'Presence of past history of AL/COPD', 'timeFrame': '1 day', 'description': 'prevalence of documented evidence of COPD, chronic bronchitis or emphysema'}, {'measure': 'COPD Assessment test™ (CAT)', 'timeFrame': '1 day', 'description': 'Health status questionnaire on burden of airflow limitation (CAT)'}, {'measure': 'Short Form 12 (SF12)', 'timeFrame': '1 day', 'description': 'General health status questionnaire (SF12)'}, {'measure': 'Cardiac Health Profile (CHP)', 'timeFrame': '1 day', 'description': 'Health status questionnaire on burden of cardiac disease'}, {'measure': 'Healthcare resource utilisation', 'timeFrame': 'within previous 12 months', 'description': 'Number of emergency room visits and hopsital admissions'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prevalence', 'COPD', 'emphysema', 'co-morbidities', 'ischemic heart disease', 'chronic bronchitis', 'spirometry', 'burden'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '27442601', 'type': 'DERIVED', 'citation': 'Franssen FM, Soriano JB, Roche N, Bloomfield PH, Brusselle G, Fabbri LM, Garcia-Rio F, Kearney MT, Kwon N, Lundback B, Rabe KF, Raillard A, Muellerova H, Cockcroft JR. Lung Function Abnormalities in Smokers with Ischemic Heart Disease. Am J Respir Crit Care Med. 2016 Sep 1;194(5):568-76. doi: 10.1164/rccm.201512-2480OC.'}]}, 'descriptionModule': {'briefSummary': 'This is a cross-sectional, observational study, investigating the point prevalence of Airflow Limitation in current or former smokers with established ischemic heart disease. The study will recruit up to 3000 patients from cardiology clinics at hospitals across Europe.', 'detailedDescription': 'Airflow limitation (AL) occurs in a number of respiratory diseases including asthma and COPD; in middle-aged and older patients it typically represents Chronic Obstructive Pulmonary Disease (COPD), and is associated with a high degree of co-morbidity which includes cardiovascular diseases (CVD) and risk factors such as hypertension and diabetes.\n\nCOPD often goes undiagnosed, especially in patients with established coronary disease because COPD and cardiovascular diseases share a major etiological factor: smoking.\n\nThis cross-sectional, observational study, investigating the prevalence of AL in current or former smokers with established ischemic heart disease, aims increase the knowledge and understanding of COPD in this patient population, and to highlight the burden of comorbid disease in these patient'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients attending outpatient cardiology clinics with a history of Ischemic Heart Disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects aged ≥40 years;\n* Current or former smokers with ≥10 pack years;\n* Subjects attending outpatient cardiac clinic (or equivalent) fulfilling any of the following criteria:\n\n 1. Documented history of an Ischemic event,\n 2. Current diagnosis of stable IHD (including history of acute Myocardial Infarction (MI) and angina pectoris) as diagnosed in accordance with ESC guidelines\n 3. Receiving regular therapy for IHD for \\>1yr, Subjects meeting these criteria will be eligible for the study, even if they have other cardiac diseases or other co-morbidities;\n* Subjects willing and able to sign study consent form.\n\nExclusion Criteria:\n\n* Subjects for whom spirometry is contraindicated;\n* Subjects with recent surgery or MI (within 1 month); lower respiratory tract infection or pneumothorax (within 2 months); or stroke (within 12 months);\n* Subjects with a pre-existing condition which, in the opinion of the investigator, would compromise the safety of the subject in this study'}, 'identificationModule': {'nctId': 'NCT01485159', 'acronym': 'ALICE', 'briefTitle': 'Airflow Limitation in Cardiac Diseases in Europe', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Airflow Limitation in Cardiac Diseases in Europe', 'orgStudyIdInfo': {'id': '115398'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All', 'description': 'All subjects enrolled in the study', 'interventionNames': ['Procedure: Spirometry']}], 'interventions': [{'name': 'Spirometry', 'type': 'PROCEDURE', 'description': 'assessment of lung function by spirometry', 'armGroupLabels': ['All']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '63263', 'city': 'Neu-Isenburg', 'state': 'Hesse', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.04832, 'lon': 8.69406}}, {'zip': '13347', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '570 10', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '4', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '9', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '41124', 'city': 'Modena', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '21049', 'city': 'Tradate (VA)', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.70843, 'lon': 8.90763}}, {'zip': '3818 ES', 'city': 'Amersfoort', 'country': 'Netherlands', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.155, 'lon': 5.3875}}, {'zip': '8601 ZK', 'city': 'Sneek', 'country': 'Netherlands', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.03297, 'lon': 5.6589}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '07010', 'city': 'Palma de Mallorca', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': 'SE-222 21', 'city': 'Lund', 'country': 'Sweden', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': 'SE-205 02', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}