Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT00793858
Status:
WITHDRAWN
Last Update Posted:
2013-06-07
First Post:
2008-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot Investigation of Ciclesonide When Administered as a Hypotonic Versus an Isotonic Formulation of Ciclesonide Nasal Spray
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Cost prohibitive and company withdrew support.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'lastUpdateSubmitDate': '2013-06-06', 'studyFirstSubmitDate': '2008-11-14', 'studyFirstSubmitQcDate': '2008-11-18', 'lastUpdatePostDateStruct': {'date': '2013-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'levels of ciclesonide in biopsy tissue', 'timeFrame': '2 hours post study drug administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure the amount of a nasal steroid spray (ciclesonide) absorbed by the tissue in the nose 2 hours after having this study drug sprayed in the nose'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males and females 18 years of age or older.\n2. History of perennial allergic rhinitis for at least 1 year prior to screening.\n3. Positive skin test to perennial allergen.\n\nExclusion Criteria:\n\n1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.\n2. Pregnant or lactating women.\n3. Upper respiratory infection within 14 days of study start.\n4. Active asthma requiring treatment with inhaled or systemic steroids.\n5. Use of any form of nasal spray during the previous month.'}, 'identificationModule': {'nctId': 'NCT00793858', 'briefTitle': 'A Pilot Investigation of Ciclesonide When Administered as a Hypotonic Versus an Isotonic Formulation of Ciclesonide Nasal Spray', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'A Pilot Investigation of the Nasal Mucosal Absorption, Retention, and Metabolism of Ciclesonide When Administered as a Hypotonic Versus an Isotonic Formulation of Ciclesonide Nasal Spray When Each Formulation Is Administered to Currently Symptomatic Patients (18 Years or Older) With Documented Perennial Allergic Rhinitis (PAR).', 'orgStudyIdInfo': {'id': '16651A (SEP 1)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'placebo in left nostril, isotonic ciclesonide in right', 'interventionNames': ['Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'hypotonic ciclesonide in left nostril, placebo in right', 'interventionNames': ['Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'hypotonic ciclesonide in right and left nostrils', 'interventionNames': ['Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'isotonic ciclesonide in both right and left nostrils', 'interventionNames': ['Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide']}, {'type': 'PLACEBO_COMPARATOR', 'label': '6', 'description': 'placebo in both right and left nostrils', 'interventionNames': ['Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5', 'description': 'isotonic ciclesonide in left nostril and hypotonic ciclesonide in right', 'interventionNames': ['Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide']}], 'interventions': [{'name': 'placebo, isotonic ciclesonide, hypotonic ciclesonide', 'type': 'DRUG', 'description': '200mcg/nostril', 'armGroupLabels': ['1', '2', '3', '4', '5', '6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sumitomo Pharma America, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}