Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-30 @ 7:05 AM
Study NCT ID:
NCT00845195
Status:
COMPLETED
Last Update Posted:
2010-04-27
First Post:
2009-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Seasonal Allergic Rhinitis Treatment With 2 Antihistamines Used in Combination With Intranasal Corticosteroid
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'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': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}]}}, '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}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Olopatadine HCl Nasal Spray, 0.6%', 'description': 'Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg', 'otherNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Azelastine HCl Nasal Spray, 0.1%', 'description': 'Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg', 'otherNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olopatadine HCl Nasal Spray, 0.6%', 'description': 'Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg'}, {'id': 'OG001', 'title': 'Azelastine HCl Nasal Spray, 0.1%', 'description': 'Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg'}], 'classes': [{'categories': [{'measurements': [{'value': '4.28', 'spread': '2.63', 'groupId': 'OG000'}, {'value': '4.15', 'spread': '2.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days minus baseline', 'description': 'Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12 . Reflective scores were assessed from the hour since the last dose of study medication.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was per protocol. 15 patients were not included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olopatadine HCl Nasal Spray, 0.6%', 'description': 'Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg'}, {'id': 'OG001', 'title': 'Azelastine HCl Nasal Spray, 0.1%', 'description': 'Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg'}], 'classes': [{'categories': [{'measurements': [{'value': '4.22', 'spread': '2.69', 'groupId': 'OG000'}, {'value': '4.04', 'spread': '2.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days minus baseline', 'description': 'Responses to patient-completed diaries for reflective Total Ocular Symptom Scores (rTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9 . Reflective scores were assessed from the hour since the last dose of study medication.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was per protocol. 15 patients were not included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olopatadine HCl Nasal Spray, 0.6%', 'description': 'Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg'}, {'id': 'OG001', 'title': 'Azelastine HCl Nasal Spray, 0.1%', 'description': 'Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg'}], 'classes': [{'categories': [{'measurements': [{'value': '2.64', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '2.49', 'spread': '2.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days minus baseline', 'description': 'Responses to patient-completed diaries for instantaneous Total Nasal Symptom Scores (iTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12 . Instantaneous scores were assessed at the time of daily dosing.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was per protocol. 15 patients were not included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olopatadine HCl Nasal Spray, 0.6%', 'description': 'Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg'}, {'id': 'OG001', 'title': 'Azelastine HCl Nasal Spray, 0.1%', 'description': 'Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg'}], 'classes': [{'categories': [{'measurements': [{'value': '2.76', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '2.54', 'spread': '2.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days minus baseline', 'description': 'Responses to patient-completed diaries for instantaneous Total Ocular Symptom Scores (iTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9 . Instantaneous scores were assessed at the time of daily dosing.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was per protocol. 15 patients were not included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Olopatadine HCl Nasal Spray, 0.6%', 'description': 'Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg'}, {'id': 'FG001', 'title': 'Azelastine HCl Nasal Spray, 0.1%', 'description': 'Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'March 8, 2009 - April 22, 2009'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Olopatadine HCl Nasal Spray, 0.6%', 'description': 'Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg'}, {'id': 'BG001', 'title': 'Azelastine HCl Nasal Spray, 0.1%', 'description': 'Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'lastUpdateSubmitDate': '2010-04-22', 'studyFirstSubmitDate': '2009-02-13', 'resultsFirstSubmitDate': '2010-03-25', 'studyFirstSubmitQcDate': '2009-02-13', 'lastUpdatePostDateStruct': {'date': '2010-04-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-03-25', 'studyFirstPostDateStruct': {'date': '2009-02-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline', 'timeFrame': '14 days minus baseline', 'description': 'Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12 . Reflective scores were assessed from the hour since the last dose of study medication.'}, {'measure': 'Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline', 'timeFrame': '14 days minus baseline', 'description': 'Responses to patient-completed diaries for reflective Total Ocular Symptom Scores (rTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9 . Reflective scores were assessed from the hour since the last dose of study medication.'}, {'measure': 'Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline', 'timeFrame': '14 days minus baseline', 'description': 'Responses to patient-completed diaries for instantaneous Total Nasal Symptom Scores (iTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12 . Instantaneous scores were assessed at the time of daily dosing.'}, {'measure': 'Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline', 'timeFrame': '14 days minus baseline', 'description': 'Responses to patient-completed diaries for instantaneous Total Ocular Symptom Scores (iTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9 . Instantaneous scores were assessed at the time of daily dosing.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rhinitis', 'Allergy', 'Nasal Spray', 'Antihistamine', 'Intranasal Corticosteroid'], 'conditions': ['Seasonal Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of Olopatadine Nasal Spray with Azelastine Nasal Spray when treatments are utilized in conjunction with Fluticasone Nasal Spray for the treatment of seasonal allergic rhinitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to provide consent/assent\n* History of spring/summer allergic rhinitis\n* Positive skin prick and/or intradermal test\n* Absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations\n* Non-pregnant (where applicable)\n* Able to complete daily diary\n\nExclusion Criteria:\n\n* Smoker\n* Concurrent disease such as rhinitis medicamentosa or large obstructive nasal polyps\n* History of current chronic sinusitis\n* Asthma\n* Use of anti-allergy immunotherapy, corticosteroids, chronic use of long acting antihistamines\n* History of severe, unstable, or uncontrolled cardiovascular, hepatic, renal and/or other diseases/illnesses\n* History or evidence of nasolacrimal drainage system malfunction'}, 'identificationModule': {'nctId': 'NCT00845195', 'briefTitle': 'Comparison of Seasonal Allergic Rhinitis Treatment With 2 Antihistamines Used in Combination With Intranasal Corticosteroid', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'SMA-08-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Olopatadine HCl Nasal Spray, 0.6%', 'interventionNames': ['Drug: Olopatadine HCl Nasal Spray, 0.6%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Azelastine HCl Nasal Spray, 0.1%', 'interventionNames': ['Drug: Azelastine HCl Nasal Spray, 0.1%']}], 'interventions': [{'name': 'Olopatadine HCl Nasal Spray, 0.6%', 'type': 'DRUG', 'description': '2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days', 'armGroupLabels': ['Olopatadine HCl Nasal Spray, 0.6%']}, {'name': 'Azelastine HCl Nasal Spray, 0.1%', 'type': 'DRUG', 'description': '2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days', 'armGroupLabels': ['Azelastine HCl Nasal Spray, 0.1%']}]}, '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 Medical Affairs- Allergy', 'oldOrganization': 'Alcon Research'}}}}