Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT00411320
Status:
COMPLETED
Last Update Posted:
2011-08-04
First Post:
2006-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Determinants of Corticosteroid Insensitivity in Smokers With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-03', 'studyFirstSubmitDate': '2006-12-12', 'studyFirstSubmitQcDate': '2006-12-12', 'lastUpdatePostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bronchodilator response to oral corticosteroid trial in smokers with asthma vs non smokers and ex-smokers with asthma', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Asthma', 'Smoking', 'Steroid Resistance', 'Corticosteroid insensitivity'], 'conditions': ['Asthma', 'Smoking', 'Steroid Resistance', 'Corticosteroid Insensitivity']}, 'referencesModule': {'references': [{'pmid': '21338429', 'type': 'DERIVED', 'citation': 'Spears M, McSharry C, Donnelly I, Jolly L, Brannigan M, Thomson J, Lafferty J, Chaudhuri R, Shepherd M, Cameron E, Thomson NC. Peripheral blood dendritic cell subtypes are significantly elevated in subjects with asthma. Clin Exp Allergy. 2011 May;41(5):665-72. doi: 10.1111/j.1365-2222.2010.03692.x. Epub 2011 Feb 21.'}], 'seeAlsoLinks': [{'url': 'http://www.gla.ac.uk/departments/immunology/respiratorymedicine/', 'label': 'unit website'}]}, 'descriptionModule': {'briefSummary': 'Smokers with asthma display a relative insensitivity to inhaled and oral corticosteroids. The causes of this phenomenon are currently unknown. The investigators will perform a number of blood \\& breathing tests to try to discover the cause/s behind this phenomenon with the aim of producing leads for further investigation and possible new treatments for smokers with asthma.', 'detailedDescription': 'Smokers with asthma display a relative insensitivity to inhaled and oral corticosteroids. The causes of this phenomenon are currently unknown. However research into steroid resistance in severe asthma and the smoking related condition chronic obstructive pulmonary disease (COPD) points to a number of possible causes. We will characterise a group of smokers with asthma and perform a number of investigations and compare the results to ex-smokers and never smokers with asthma with the aim of establishing which previously published steroid resistance phenomena are related to the steroid resistance displayed by smokers with asthma. Results produced from this trial will provide hypothesis generating information leading to future pharmaceutical trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asthma (defined by either reversibility to bronchodilator or methacholine testing)\n* Asthma duration of 6 months or greater\n* Stable asthma\n* Age 18-60\n* Treatment with inhaled corticosteroids\n* Smoking history consistent with group\n\n * smokers with asthma: \\> or = 5 pack years and currently smoking more than 5 cigarettes per day\n * ex-smokers: smoking ceased \\> or = two years prior to recruitment, minimum 5 pack year history\n * non-smokers: no smoking history\n\nExclusion Criteria:\n\n* Presence of medical condition likely to be exacerbated by treatment with oral corticosteroids\n* Treatment with \\> 2000 mcg beclomethasone (or equivalent) per day\n* Subject requires oral corticosteroids to maintain asthma control\n* Subject requires oral theophylline to maintain asthma control\n* Recent treatment with oral corticosteroids\n* Pregnancy or subject planning to become pregnant'}, 'identificationModule': {'nctId': 'NCT00411320', 'briefTitle': 'Determinants of Corticosteroid Insensitivity in Smokers With Asthma', 'organization': {'class': 'OTHER', 'fullName': 'University of Glasgow'}, 'officialTitle': 'Determinants of Corticosteroid Insensitivity in Smokers With Asthma', 'orgStudyIdInfo': {'id': 'AR002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Smokers with asthma', 'interventionNames': ['Drug: oral steroid-dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Ex-smokers with asthma', 'interventionNames': ['Drug: oral steroid-dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': 'Non-smokers with asthma', 'interventionNames': ['Drug: oral steroid-dexamethasone']}, {'type': 'NO_INTERVENTION', 'label': 'Group 4', 'description': 'Non smokers without asthma'}, {'type': 'NO_INTERVENTION', 'label': 'Group 5', 'description': 'Smokers without asthma or COPD'}], 'interventions': [{'name': 'oral steroid-dexamethasone', 'type': 'DRUG', 'description': '2 week steroid trial', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G12 0YN', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Asthma Research Unit, Glasgow University', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Mark Spears, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Glasgow'}, {'name': 'Neil C Thomson, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Glasgow'}, {'name': 'Rekha Chaudhuri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Glasgow'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Glasgow', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chief Scientist Office of the Scottish Government', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Dr Caroline Watson, R&D Manager', 'oldOrganization': 'NHS Greater Glasgow and Clyde (North Glasgow University Hospitals Division)'}}}}