Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-03-02 @ 9:45 AM
Study NCT ID:
NCT00651118
Status:
COMPLETED
Last Update Posted:
2012-09-26
First Post:
2008-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'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': 'C020976', 'term': 'azelastine'}, {'id': 'D000068298', 'term': 'Fluticasone'}, {'id': 'C573864', 'term': 'MP29-02'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.ginsberg@meda.us', 'phone': '732 564 2364', 'title': 'David Ginsberg,..', 'organization': 'Meda Pharmaceutical'}, 'certainAgreement': {'otherDetails': 'Investigators participating in multicenter studies must agree not to present data gathered individually or by a subgroup of centers before the full, initial publication, unless this has been agreed to by all other investigators and Meda Pharmaceuticals.\n\nMeda Pharmaceuticals requests that it receive copies of any intended communication reasonably in advance (at least 15 working days for an abstract or oral presentation and 45 working days for a manuscript)', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'MP29-02', 'description': 'MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray', 'otherNumAtRisk': 207, 'otherNumAffected': 12, 'seriousNumAtRisk': 207, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fluticasone Propionate', 'description': 'fluticasone propionate nasal spray', 'otherNumAtRisk': 207, 'otherNumAffected': 16, 'seriousNumAtRisk': 207, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Azelastine HCl', 'description': 'azelastine HCl nasal spray nasal spray', 'otherNumAtRisk': 208, 'otherNumAffected': 19, 'seriousNumAtRisk': 208, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'placebo nasal spray', 'otherNumAtRisk': 210, 'otherNumAffected': 7, 'seriousNumAtRisk': 210, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'dysgusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 210, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 210, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 208, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '1.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (rTNSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MP29-02', 'description': 'MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray'}, {'id': 'OG001', 'title': 'Fluticasone Propionate', 'description': 'fluticasone propionate nasal spray'}, {'id': 'OG002', 'title': 'Azelastine HCl', 'description': 'azelastine HCl nasal spray nasal spray'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'placebo nasal spray'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.6', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '4.7', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '4.6', 'groupId': 'OG002'}, {'value': '-2.9', 'spread': '3.9', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'days 1 to 14', 'description': 'change from baseline in 12-hour reflective(how did you feel in the last 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.\n\nThe measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative value the better the result.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intent to treat population (ITT)- must have had at least one post baseline efficacy assessment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MP29-02', 'description': 'fluticasone propionate 50 mcg / azelastine HCl 137 mcg nasal spray'}, {'id': 'OG001', 'title': 'Fluticasone Propionate', 'description': 'fluticasone propionate nasal spray'}, {'id': 'OG002', 'title': 'Azelastine HCl', 'description': 'azelastine HCl nasal spray'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo nasal spray'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.2', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '4.7', 'groupId': 'OG001'}, {'value': '-4.0', 'spread': '4.7', 'groupId': 'OG002'}, {'value': '-2.6', 'spread': '4.1', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'day 1 to day 14', 'description': 'change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.\n\nThe measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative the value the better the result.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intent to treat population (ITT)- must have had at least one post baseline efficacy assessment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '169', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MP29-02', 'description': 'MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray'}, {'id': 'OG001', 'title': 'Fluticasone Propionate', 'description': 'fluticasone propionate nasal spray'}, {'id': 'OG002', 'title': 'Azelastine HCl', 'description': 'azelastine HCl nasal spray nasal spray'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'placebo nasal spray'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '-0.9', 'spread': '1.1', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'day 1 to day 14', 'description': 'adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.\n\nThe scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement.The more negative the value the better the result.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intent to treat( ITT)population (18 yrs of age or older) must have had at least one post baseline efficacy assessment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MP29-02', 'description': 'MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray'}, {'id': 'FG001', 'title': 'Fluticasone Propionate', 'description': 'fluticasone propionate nasal spray'}, {'id': 'FG002', 'title': 'Azelastine HCl', 'description': 'azelastine HCl nasal spray nasal spray'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'placebo nasal spray'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '207'}, {'groupId': 'FG001', 'numSubjects': '207'}, {'groupId': 'FG002', 'numSubjects': '208'}, {'groupId': 'FG003', 'numSubjects': '210'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '200'}, {'groupId': 'FG002', 'numSubjects': '197'}, {'groupId': 'FG003', 'numSubjects': '203'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}, {'value': '210', 'groupId': 'BG003'}, {'value': '832', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'MP29-02', 'description': 'MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray'}, {'id': 'BG001', 'title': 'Fluticasone Propionate', 'description': 'fluticasone propionate nasal spray'}, {'id': 'BG002', 'title': 'Azelastine HCl', 'description': 'azelastine HCl nasal spray nasal spray'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'placebo nasal spray'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}, {'value': '706', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'spread': '14.1', 'groupId': 'BG000'}, {'value': '38.6', 'spread': '14.1', 'groupId': 'BG001'}, {'value': '36.2', 'spread': '14.6', 'groupId': 'BG002'}, {'value': '37.3', 'spread': '16.0', 'groupId': 'BG003'}, {'value': '37.3', 'spread': '14.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}, {'value': '532', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}, {'value': '300', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}, {'value': '210', 'groupId': 'BG003'}, {'value': '832', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 832}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'dispFirstSubmitDate': '2011-06-23', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-27', 'studyFirstSubmitDate': '2008-03-28', 'dispFirstSubmitQcDate': '2011-07-12', 'resultsFirstSubmitDate': '2012-05-10', 'studyFirstSubmitQcDate': '2008-03-28', 'dispFirstPostDateStruct': {'date': '2011-07-14', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-09-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-27', 'studyFirstPostDateStruct': {'date': '2008-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (rTNSS)', 'timeFrame': 'days 1 to 14', 'description': 'change from baseline in 12-hour reflective(how did you feel in the last 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.\n\nThe measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative value the better the result.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)', 'timeFrame': 'day 1 to day 14', 'description': 'change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.\n\nThe measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative the value the better the result.'}, {'measure': 'Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days', 'timeFrame': 'day 1 to day 14', 'description': 'adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.\n\nThe scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement.The more negative the value the better the result.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Seasonal Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)', 'detailedDescription': 'This will be a Phase III, randomized, double-blind, placebo-controlled, parallel-group study in subjects with moderate-to-severe seasonal allergic rhinitis (SAR). The study will begin with a 7-day, single-blind, placebo lead-in period (Day -7 to Day 1). Subjects will be instructed to take placebo lead-in medication twice daily (1 spray per nostril), approximately every 12 hours. On Day 1, subjects who satisfy the symptom severity requirements and continue to meet all of the study inclusion/exclusion criteria will be randomized in a 1:1:1:1 ratio to receive 1 spray per nostril twice daily of MP29-02, azelastine hydrochloride, fluticasone propionate, or placebo nasal spray.\n\nEfficacy will be assessed by the change from baseline in the subject-reported 12-hour reflective Total Nasal Symptom Score (TNSS). On Days 1 through 14, subjects will rate the instantaneous and reflective TNSS symptoms of sneezing, nasal congestion, runny nose, and nasal itching; the instantaneous and reflective total ocular symptom score (TOSS) symptoms of itchy eyes, watery eyes and eye redness; and the symptom of postnasal drip, twice daily (AM and PM) in a diary prior to the dose of study medication. Symptoms will be scored on a 0 to 3 scale (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms), such that the maximum daily symptom severity score will be 24 for the TNSS and 18 for the TOSS. Additional secondary efficacy variables will include reflective individual nasal and ocular symptom scores, as well as change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).\n\nSubjects ≥ 18 years of age will complete the RQLQ on Day 1 (prior to dosing) and Day 14. Subjects will return to the clinic on Day 7 for an interim evaluation. After completing the 2-week double-blind treatment period, subjects will return to the clinic on Day 14 (or at time of early termination) for an end-of-study evaluation. Safety and tolerability assessments will be made on Days 7 and 14. Tolerability will be evaluated by subject-reported adverse events (AEs), nasal examinations, and vital signs assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis\n* Must be in generally good health\n* Must meet minimum symptom requirements, as specified in the protocol\n* Must be wiling and able to provide informed consent and to participate all study procedures\n* Positive skin test to a prevalent spring allergen\n\nExclusion criteria:\n\n* On nasal examination,the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation\n* Nasal disease likely to affect the deposition of the medication or evaluation, such as sinus infection, nasal polyps or severe deviated septum\n* Nasal or sinus surgery within the previous 6 months\n* Chronic sinus infection (more than 3 per year)\n* Planned travel outside the study area during the study period\n* Use of any investigational drug within 30 days of the first visit\n* Hypersensitivity (bad reaction) to azelastine hydrchloride nasal spray (Astelin), or fluticasone propionate nasal spray (Flonase)\n* Women who are not using an acceptable method or birth control\n* Women who are pregnant or nursing\n* Upper respiratory tract infection such as common cold, flu, sinus infection within 2 weeks of first study visit\n* Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with the investigator\n* Irregular heartbeat or other symptomatic heart conditions\n* History of alcohol or drug abuse\n* History of glaucoma\n* Use of medications that could affect the study results'}, 'identificationModule': {'nctId': 'NCT00651118', 'briefTitle': 'A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Meda Pharmaceuticals'}, 'officialTitle': 'Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis', 'orgStudyIdInfo': {'id': 'MP4002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'fluticasone propionate', 'interventionNames': ['Drug: fluticasone propionate']}, {'type': 'EXPERIMENTAL', 'label': 'azelastineHcl/fluticasone 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