Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-30 @ 9:29 AM
Study NCT ID:
NCT01430260
Status:
COMPLETED
Last Update Posted:
2012-09-06
First Post:
2011-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omnaris Versus Levocetirizine Phase 4 Study
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': 'C120481', 'term': 'ciclesonide'}, {'id': 'C472067', 'term': 'levocetirizine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 349}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-05', 'studyFirstSubmitDate': '2011-09-06', 'studyFirstSubmitQcDate': '2011-09-07', 'lastUpdatePostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rTNSS', 'timeFrame': '2 weeks', 'description': 'change from baseline in the average of AM and PM patient assessed reflective TNSS'}], 'secondaryOutcomes': [{'measure': 'rTOSS', 'timeFrame': '2 weeks', 'description': 'Reflective total ocular symptom sores'}, {'measure': 'TNSS', 'timeFrame': '2 weeks', 'description': 'Patient assessed individual TNSS'}, {'measure': 'PANS', 'timeFrame': '2 weeks', 'description': 'Physician-assessed overall nasal signs and symptoms severity (PANS)'}, {'measure': 'RQLQ', 'timeFrame': '2 weeks', 'description': 'Rhinoconjunctivitis quality of life questionnaire (RQLQ)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['efficacy', 'ciclesonide', 'levocetirizine', 'allergic rhinitis'], 'conditions': ['Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'This i a comparison of the efficacy ciclesonide nasal spray and levocetirizine, alone and in combination.', 'detailedDescription': 'randomized, open-label, three arm, parallel group, multi-center study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Allergic rhinitis patients aged ≥ 18 years (with a history of AR of 1 years or longer)\n* Moderate to severe patient according to ARIA guideline\n* To have a demonstrated positive skin prick test or other serologic tests to at least 1 allergen.\n* Subjects who complete the subject diary(S) at least 70%.\n\nExclusion Criteria:\n\n* Nasal pathology, including nasal polyps, clinically relevant respiratory tract malformations, recent nasal biopsy (within 60 days), nasal trauma, nasal surgery, atrophic rhinitis, rhinitis medicamentosa (within 60 days), asthma requiring corticosteroid treatment\n* Hypersensitivity to corticosteroid and/or hydroxyzine\n* Hypersensitivity to galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption\n* A history of respiratory tract infection or disorder within 2 weeks of the screening visit or had a respiratory tract infection during baseline\n* Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of β-agonists\n* Treated with systemic corticosteroids (within 8 weeks of study initiation) or topical corticosteroids (\\> 1% hydrocortisone, within 4 weeks of study initiation) or antibiotics (within 2 weeks of first visit)'}, 'identificationModule': {'nctId': 'NCT01430260', 'briefTitle': 'Omnaris Versus Levocetirizine Phase 4 Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Handok Inc.'}, 'officialTitle': 'A Multi-center, Open, Randomized, Three-arm, Parallel-group, Phase IV Study to Compare the Efficacy of Ciclesonide Nasal Spray and Levocetirizine, Alone and in Combination for the Patient With Allergic Rhinitis', 'orgStudyIdInfo': {'id': 'HANDOK2010.07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ciclesonide nasal spray', 'description': 'ciclesonide nasal spray, alone', 'interventionNames': ['Drug: Ciclesonide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Levocetirizine', 'description': 'Levocetirizine, alone', 'interventionNames': ['Drug: Levocetirizine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ciclesonide nasal spray & Levocetirizine', 'description': 'Ciclesonide nasal spray \\& Levocetirizine in combination', 'interventionNames': ['Drug: Ciclesonide & Levocetirizine']}], 'interventions': [{'name': 'Ciclesonide', 'type': 'DRUG', 'otherNames': ['Omnaris'], 'description': '200 ㎍ once daily', 'armGroupLabels': ['ciclesonide nasal spray']}, {'name': 'Levocetirizine', 'type': 'DRUG', 'otherNames': ['XYZAL'], 'description': '5mg once daily', 'armGroupLabels': ['Levocetirizine']}, {'name': 'Ciclesonide & Levocetirizine', 'type': 'DRUG', 'otherNames': ['Omnaris nasal spray', 'XYZAL'], 'description': '* Omnaris (ciclesonide) 200 ㎍ once daily\n* Levocetirizine 5mg once daily', 'armGroupLabels': ['Ciclesonide nasal spray & Levocetirizine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-755', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'handok pharmaceuticals co. LTD', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Moonhwa Park, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Handok Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Handok Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Takeda', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}