Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-26 @ 10:30 AM
Study NCT ID:
NCT01537692
Status:
COMPLETED
Last Update Posted:
2012-02-23
First Post:
2012-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate the Pharmacokinetics and Safety of BDP HFA Nasal Aerosol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001507', 'term': 'Beclomethasone'}], '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'}, {'id': 'D013258', 'term': 'Steroids, Chlorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-22', 'studyFirstSubmitDate': '2012-02-15', 'studyFirstSubmitQcDate': '2012-02-22', 'lastUpdatePostDateStruct': {'date': '2012-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': '24 hours post dose', 'description': '* Area under the plasma concentration time curve until the last measurable value (AUClast) for 17-BMP\n* Maximum plasma concentration (Cmax) for 17-BMP'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': '24 hours post dose', 'description': '* Area under the plasma concentration time curve extrapolated to infinity (AUC0-inf), time to mean peak plasma concentration (Tmax), and the terminal elimination half-life (t1/2) for 17-BMP\n* AUClast, AUC0-inf, Cmax, Tmax, t1/2 for BDP'}, {'measure': 'Safety and tolerability of BDP HFA nasal aerosol', 'timeFrame': '24 hours post dose', 'description': 'Change from baseline in safety and tolerability endpoints - including Adverse events, changes in vital signs (blood pressure and pulse rate) and ENT exams (every visit) and safety laboratory assessments and physical exams (end of study)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergic Rhinitis']}, 'referencesModule': {'references': [{'pmid': '22621776', 'type': 'DERIVED', 'citation': 'Ratner PH, Melchior A, Dunbar SA, Tantry SK, Dorinsky PM. Pharmacokinetic profile of beclomethasone dipropionate hydrofluoroalkane after intranasal administration versus oral inhalation in healthy subjects: results of a single-dose, randomized, open-label, 3-period crossover study. Clin Ther. 2012 Jun;34(6):1422-31. doi: 10.1016/j.clinthera.2012.04.023. Epub 2012 May 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the systemic levels of beclomethasone 17 monopropionate (17 BMP - the active metabolite of BDP) after intranasal administration of BDP HFA with the systemic levels of 17 BMP after administration of orally inhaled BDP HFA in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed Consent\n* Male or female subjects 18-45 years of age\n* General good health\n\nExclusion Criteria:\n\n* History of physical findings of nasal pathology (within 60 days prior to Screening Visit)\n* Participation in any investigational drug study 30 days preceding Screening Visit\n* History of respiratory infection/disorder with 28 days preceding Screening Visit'}, 'identificationModule': {'nctId': 'NCT01537692', 'briefTitle': 'Clinical Study to Evaluate the Pharmacokinetics and Safety of BDP HFA Nasal Aerosol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Randomized, Open-Label, 3-Period Crossover Study to Investigate the Pharmacokinetics, Safety and Tolerability of BDP HFA Nasal Aerosol in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'BDP-AR-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BDP HFA Nasal Aerosol 80 mcg/d', 'description': 'single dose, intranasal aerosol', 'interventionNames': ['Drug: BDP HFA Nasal Aerosol']}, {'type': 'EXPERIMENTAL', 'label': 'BDP HFA Nasal Aerosol 320 mcg/d', 'description': 'single dose, intranasal aerosol', 'interventionNames': ['Drug: BDP HFA Nasal Aerosol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BDP HFA Inhalation Aerosol 320 mcg/d', 'description': 'single dose, orally inhaled aerosol', 'interventionNames': ['Drug: BDP HFA Inhalation Aerosol (QVAR)']}], 'interventions': [{'name': 'BDP HFA Nasal Aerosol', 'type': 'DRUG', 'description': 'BDP HFA Nasal 80mcg', 'armGroupLabels': ['BDP HFA Nasal Aerosol 80 mcg/d']}, {'name': 'BDP HFA Nasal Aerosol', 'type': 'DRUG', 'description': 'BDP HFA Nasal 320mcg', 'armGroupLabels': ['BDP HFA Nasal Aerosol 320 mcg/d']}, {'name': 'BDP HFA Inhalation Aerosol (QVAR)', 'type': 'DRUG', 'description': 'BDP HFA Oral 320mcg', 'armGroupLabels': ['BDP HFA Inhalation Aerosol 320 mcg/d']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sudeesh Tantry, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Teva Global Respiratory Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}