Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-01 @ 4:33 PM
Study NCT ID:
NCT00772304
Status:
COMPLETED
Last Update Posted:
2010-03-02
First Post:
2008-10-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Sensory Attributes of Olopatadine 0.6% and Azelastine 137mcg Nasal Sprays in Patients w/Allergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}], 'ancestors': [{'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'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069605', 'term': 'Olopatadine Hydrochloride'}, {'id': 'C020976', 'term': 'azelastine'}], 'ancestors': [{'id': 'D003990', 'term': 'Dibenzoxepins'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@alconlabs.com', 'phone': '888.451.3937; 817.568.6725', 'title': 'Alcon Clinical', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Small sample size. The severity of symptoms experienced by patients may have masked their ability to detect taste and smell.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Olopatadine 0.6% / Azelastine 137 Mcg', 'description': 'Olopatadine 0.6% / Azelastine 137 mcg', 'otherNumAtRisk': 102, 'otherNumAffected': 0, 'seriousNumAtRisk': 102, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Product Preference Questionnaire for Immediate Taste', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olopatadine 0.6% / Azelastine 137 Mcg', 'description': 'Olopatadine 0.6% / Azelastine 137 mcg'}], 'classes': [{'title': 'Preferred Azelastine Strongly', 'categories': [{'measurements': [{'value': '26.47', 'groupId': 'OG000'}]}]}, {'title': 'Preferred Azelastine Somewhat', 'categories': [{'measurements': [{'value': '10.78', 'groupId': 'OG000'}]}]}, {'title': 'Preferred Azelastine Slightly', 'categories': [{'measurements': [{'value': '5.88', 'groupId': 'OG000'}]}]}, {'title': 'Same', 'categories': [{'measurements': [{'value': '15.69', 'groupId': 'OG000'}]}]}, {'title': 'Preferred Olopatadine Slightly', 'categories': [{'measurements': [{'value': '8.82', 'groupId': 'OG000'}]}]}, {'title': 'Preferred Olopatadine Somewhat', 'categories': [{'measurements': [{'value': '8.82', 'groupId': 'OG000'}]}]}, {'title': 'Preferred Olopatadine Strongly', 'categories': [{'measurements': [{'value': '23.53', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 min post-dose', 'description': 'Using a set of coded responses, subjects evaluated product preference in regards to immediate taste', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Taste and Aftertaste of Medication', 'timeFrame': '5 min, 45 min.', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Olopatadine 0.6% / Azelastine 137 Mcg', 'description': 'Olopatadine 0.6% / Azelastine 137 mcg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'October 2008- November 2008'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Olopatadine 0.6% / Azelastine 137 Mcg', 'description': 'Olopatadine 0.6% / Azelastine 137 mcg'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '101', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'lastUpdateSubmitDate': '2010-02-23', 'studyFirstSubmitDate': '2008-10-13', 'resultsFirstSubmitDate': '2009-12-03', 'studyFirstSubmitQcDate': '2008-10-13', 'lastUpdatePostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-01-11', 'studyFirstPostDateStruct': {'date': '2008-10-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Product Preference Questionnaire for Immediate Taste', 'timeFrame': '5 min post-dose', 'description': 'Using a set of coded responses, subjects evaluated product preference in regards to immediate taste'}], 'secondaryOutcomes': [{'measure': 'Taste and Aftertaste of Medication', 'timeFrame': '5 min, 45 min.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rhinitis'], 'conditions': ['Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'To compare patient perceptions of the sensory attributes, including taste and aftertaste, of Olopatadine relative to azelastine when administered as a single dose in patients with allergic rhinitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Must have a history (at least 2 yrs) of allergic rhinitis and be symptomatic at time of enrollment\n2. 18 yrs of age or older\n3. Read and sign informed consent\n4. Females of childbearing potential may participate if: are non-breast feeding, have negative urine pregnancy test at visit 1, agree to take urine pregnancy test upon exiting study, do not intend to become pregnant during the study, are using adequate methods of birth control.\n\nExclusion Criteria:\n\n1. History of intolerance or hypersensitivity to any component of the study medications, including benzalkonium chloride.\n2. Any disease or systemic disorder that may complicate or interfere with investigation or evaluation of the study medications (including but not limited to): Rhinitis medicamentosa, large obstructive nasal polyps, history (w/in last 3 months) of nasal septic ulcers, nasal surgery or nasal trauma, history or evidence of nasolacrimal drainage system malfunction, history (w/in 30 days) or evidence of sinusitis or upper or lower respiratory infection.\n3. Impairment of sense of tast or smell (self reported)\n4. Asthma, except for mild, intermittent asthma (nat'l Asthma guidelines)\n5. Congestion, that in the opinion of the investigator, that would interfere with successful nasal drug administration/absorption\n6. Patients w/a severe impairment of nasal breathing\n7. Anatomic abnormalities of as identified by nasal examination\n8. History of or current severe or uncontrolled cardiovascular, hepatic, renal and/or other disease/illness that could interfere w/study.\n9. History of (w/in past 12 months) or ongoing clinically relevant electrolyte abnormalities."}, 'identificationModule': {'nctId': 'NCT00772304', 'briefTitle': 'Evaluation of the Sensory Attributes of Olopatadine 0.6% and Azelastine 137mcg Nasal Sprays in Patients w/Allergic Rhinitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'SMA-08-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Olopatadine 0.6% / Azelastine 137 mcg', 'interventionNames': ['Drug: Olopatadine 0.6% / Azelastine 137 mcg']}], 'interventions': [{'name': 'Olopatadine 0.6% / Azelastine 137 mcg', 'type': 'DRUG', 'description': 'single dose; 2 sprays per nostril', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Alcon Call Center for Trial Locations', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Michael Edwards, PhD\\Global Scientific Market Affairs', 'oldOrganization': 'Alcon Research'}}}}