Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 11:24 AM
Study NCT ID:
NCT00920933
Status:
COMPLETED
Last Update Posted:
2010-04-09
First Post:
2009-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of AIN457 on Ozone-induced Airway Neutrophilia Compared to Placebo and Corticosteroid in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C555450', 'term': 'secukinumab'}, {'id': 'D011239', 'term': 'Prednisolone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'lastUpdateSubmitDate': '2010-04-08', 'studyFirstSubmitDate': '2009-06-12', 'studyFirstSubmitQcDate': '2009-06-12', 'lastUpdatePostDateStruct': {'date': '2010-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total neutrophil cell count in 106/mL in induced sputum', 'timeFrame': 'Day 16'}], 'secondaryOutcomes': [{'measure': 'Serum total IL-17A', 'timeFrame': 'Day 1- Day 120'}, {'measure': 'Percentage neutrophil cell count in induced sputum', 'timeFrame': 'Day 16'}, {'measure': 'Safety and tolerability. Safety assessments will include vital signs, electrocardiograms (ECG), spirometry, pulse oximetry, immunogenicity and adverse events (AEs)', 'timeFrame': 'Day 1-Day 120'}, {'measure': 'Airway function (FEV1, FVC, and FEF25-75)', 'timeFrame': '4h, 24h, and 48h after the start of the ozone exposure'}, {'measure': 'Serum AIN457 pharmacokinetics (PK)', 'timeFrame': 'Day1-Day 120'}]}, 'conditionsModule': {'keywords': ['Ozone challenge', 'airway neutrophilia', 'induced sputum', 'Healthy volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study will assess the ability of AIN457 to attenuate the increase in airway neutrophils that is seen following ozone exposure. Healthy subjects will be treated with AIN457, placebo, or oral corticosteroid and the response to a subsequent ozone exposure will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Healthy subjects\n* Normal sputum neutrophil levels at screening\n* Ozone responsive\n\nExclusion criteria:\n\n* Smokers\n* Prior treatment with antibody treatment or immunosuppressive agent\n* Presence or history of a major chronic inflammatory autoimmune disease\n* History of severe hypersensitivity to any biological agents (antibody or soluble receptor), a history of serious allergic reaction, collagen disease, neurological disease (including demyelinating disease).\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00920933', 'briefTitle': 'Effect of AIN457 on Ozone-induced Airway Neutrophilia Compared to Placebo and Corticosteroid in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Double Blind, Placebo Controlled, Parallel Group Study With an Open Label Reference Arm to Assess the Effects of Intravenously Administered AIN457 on Ozone Induced Neutrophilia Compared to Placebo & Oral Corticosteroid in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'CAIN457A2104'}, 'secondaryIdInfos': [{'id': '2008-002854-39'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AIN457', 'interventionNames': ['Biological: AIN457']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'oral corticosteroid', 'interventionNames': ['Drug: prednisolone']}], 'interventions': [{'name': 'AIN457', 'type': 'BIOLOGICAL', 'armGroupLabels': ['AIN457']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}, {'name': 'prednisolone', 'type': 'DRUG', 'armGroupLabels': ['oral corticosteroid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Großhansdorf', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.66528, 'lon': 10.28552}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis Pharmaceuticals'}}}}