Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT00691951
Status:
COMPLETED
Last Update Posted:
2008-10-21
First Post:
2008-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Budesonide & Budesonide/Formoterol on Smoking Asthmatic Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2012-07-30', 'releaseDate': '2012-06-26'}], 'estimatedResultsFirstSubmitDate': '2012-06-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019819', 'term': 'Budesonide'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'lastUpdateSubmitDate': '2008-10-17', 'studyFirstSubmitDate': '2008-06-04', 'studyFirstSubmitQcDate': '2008-06-05', 'lastUpdatePostDateStruct': {'date': '2008-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparative changes before and after treatments in each group for Asthma Control Questionnaire (ACQ)'}], 'secondaryOutcomes': [{'measure': 'Other control scores (ACSS score) and rescue B2 agonist need'}, {'measure': 'Comparative changes in FEV1'}, {'measure': 'Quality of life questionnaire'}, {'measure': 'Morning and evening PEF'}, {'measure': 'Total and differential cell counts in induced sputum and ECP and MPO'}]}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'A reduced response to inhaled corticosteroids (ICS) has been reported in smoking compared to non-smoking asthmatic patients. However, the comparative response to other currently prescribed medications such as combination therapy of long-acting beta agonists and ICS remain to be further evaluated.\n\nNo significant differences were found between our group of subjects in regard to changes in asthma control pulmonary function and airway inflammation following budesonide or the association of budesonide with formoterol for a period of 2 months. This should be further explored in larger groups of subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asthmatic non-smokers or ex-smokers (less than 10 pack/years)\n* Asthmatic smokers (more than 5 cigarettes a day and more than 5 pack/years\n* FEV1 greater than 70%\n* No more than 3 doses of rescue medication (bronchodilator) per day\n\nExclusion Criteria:\n\n* Mentally or legally incapacitated thus preventing informed consent from being obtained\n* Other pulmonary disorder\n* History of upper respiratory tract infection in the last month\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT00691951', 'acronym': 'D5890L00013', 'briefTitle': 'Effects of Budesonide & Budesonide/Formoterol on Smoking Asthmatic Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Comparative Effects of Budesonide and Budesonide/Formoterol (Symbicort) on Asthma Control in Smoking Asthmatic Subjects: A Pilot Study', 'orgStudyIdInfo': {'id': 'Symbicort smokers AZ'}}, 'armsInterventionsModule': {'interventions': [{'name': 'budesonide and budesonide/formoterol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H4J 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hôpital du Sacré-Coeur de Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Laval Hospital', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Louis-Philippe Boulet', 'oldOrganization': 'Laval University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2012-06-26', 'type': 'RELEASE'}, {'date': '2012-07-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Louis-Philippe Boulet, Professeur adjoint, Laval University'}}}}