Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT00712920
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2008-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'WWheeler@medapharma.us', 'phone': '732-564-2393', 'title': 'William Wheeler, PhD', 'organization': 'Meda Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'For multicenter studies, joint publication is required to assure that the initial publication is based on all data from all sites and investigators participating in these studies agree not to present data gathered individually or by subgroup centers before the initial publication unless jointly agreed by all other investigators and the sponsor. authorship will be determined by mutual agreement.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Standard deviations for primary endpoint are not available.'}}, 'adverseEventsModule': {'description': "0 participants were at risk for an SAE. No SAE's were observed", 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks', 'otherNumAtRisk': 192, 'otherNumAffected': 21, 'seriousNumAtRisk': 192, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Astepro 0.1%', 'description': '0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks', 'otherNumAtRisk': 194, 'otherNumAffected': 27, 'seriousNumAtRisk': 194, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Astepro 0.15%', 'description': '0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks', 'otherNumAtRisk': 192, 'otherNumAffected': 32, 'seriousNumAtRisk': 192, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 192, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dysgesusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 192, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 192, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 192, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 192, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks'}, {'id': 'OG001', 'title': 'Astepro 0.1%', 'description': '0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks'}, {'id': 'OG002', 'title': 'Astepro 0.15%', 'description': '0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks'}], 'classes': [{'title': 'Baseline Least Squares Mean Symptom Score', 'categories': [{'measurements': [{'value': '14.7', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '15.5', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '15.8', 'spread': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline LS Mean symptom score', 'categories': [{'measurements': [{'value': '-3.1', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '-4.0', 'spread': '0.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.90', 'ciLowerLimit': '-1.70', 'ciUpperLimit': '-0.10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.', 'testedNonInferiority': False}, {'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '0.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'baseline and 28 days', 'description': 'Reflective total nasal symptom score consisting of Runny nose, itchy nose, nasal Congestion, and Sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day\n\nLeast square means (LS Mean) was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.', 'unitOfMeasure': 'Scores on a Scale', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks'}, {'id': 'OG001', 'title': 'Astepro 0.1%', 'description': '0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks'}, {'id': 'OG002', 'title': 'Astepro 0.15%', 'description': '0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks'}], 'classes': [{'title': 'Baseline Symptom score', 'categories': [{'measurements': [{'value': '13.28', 'spread': '4.614', 'groupId': 'OG000'}, {'value': '13.91', 'spread': '4.616', 'groupId': 'OG001'}, {'value': '14.30', 'spread': '4.572', 'groupId': 'OG002'}]}]}, {'title': 'Overall Change from baseline', 'categories': [{'measurements': [{'value': '-2.72', 'spread': '4.129', 'groupId': 'OG000'}, {'value': '-3.36', 'spread': '3.898', 'groupId': 'OG001'}, {'value': '-3.51', 'spread': '4.166', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.102', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.6419', 'ciLowerLimit': '-1.41', 'ciUpperLimit': '0.13', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.3924', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.', 'testedNonInferiority': False}, {'pValue': '0.044', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.7925', 'ciLowerLimit': '-1.56', 'ciUpperLimit': '-0.02', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.3935', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 28 days', 'description': 'instantaneous (subjects rate how they feel "right now") total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks'}, {'id': 'OG001', 'title': 'Astepro 0.1%', 'description': '0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks'}, {'id': 'OG002', 'title': 'Astepro 0.15%', 'description': '0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks'}], 'classes': [{'title': 'Baseline SSCS', 'categories': [{'measurements': [{'value': '11.20', 'spread': '4.936', 'groupId': 'OG000'}, {'value': '11.77', 'spread': '5.036', 'groupId': 'OG001'}, {'value': '12.39', 'spread': '4.885', 'groupId': 'OG002'}]}]}, {'title': 'Change in baseline to Day 28', 'categories': [{'measurements': [{'value': '-1.79', 'spread': '3.420', 'groupId': 'OG000'}, {'value': '-2.23', 'spread': '3.865', 'groupId': 'OG001'}, {'value': '-2.92', 'spread': '4.053', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.226', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.4394', 'ciLowerLimit': '-1.15', 'ciUpperLimit': '0.27', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.3631', 'groupDescription': 'Change in baseline to Day 28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-1.1252', 'ciLowerLimit': '-1.84', 'ciUpperLimit': '-0.41', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.3649', 'groupDescription': 'Change in baseline to Day 28', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 28 days', 'description': 'Reflective secondary symptom complex scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks'}, {'id': 'OG001', 'title': 'Astepro 0.1%', 'description': '0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks'}, {'id': 'OG002', 'title': 'Astepro 0.15%', 'description': '0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks'}], 'classes': [{'title': 'Baseline: Overall', 'categories': [{'measurements': [{'value': '2.98', 'spread': '1.047', 'groupId': 'OG000'}, {'value': '3.18', 'spread': '1.048', 'groupId': 'OG001'}, {'value': '3.29', 'spread': '1.091', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline:Overall', 'categories': [{'measurements': [{'value': '-0.81', 'spread': '1.112', 'groupId': 'OG000'}, {'value': '-1.05', 'spread': '1.088', 'groupId': 'OG001'}, {'value': '-0.94', 'spread': '1.096', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.292', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate', 'testedNonInferiority': False}, {'pValue': '0.040', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 28 Days', 'description': 'A 28-item RQLQ was completed on Day 1 and Day 28 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on Direct Visual Nasal Exams and 28 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks'}, {'id': 'OG001', 'title': 'Astepro 0.1%', 'description': '0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks'}, {'id': 'OG002', 'title': 'Astepro 0.15%', 'description': '0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks'}], 'classes': [{'title': 'Epistaxis: screening - None (n=192,197,192)', 'categories': [{'measurements': [{'value': '189', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '185', 'groupId': 'OG002'}]}]}, {'title': 'Epistaxis: screening - Mild (n=192,197,192)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Epistaxis: screening - Moderate (n=192,197,192)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Epistaxis: screening - Severe (n=192,197,192)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Epistaxis: Day 28/ET - None (n=190,192,192)', 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}]}, {'title': 'Epistaxis: Day 28/ET - Mild (n=190,192,192)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Epistaxis: Day 28/ET - Moderate (n=190,192,192)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Epistaxis: Day 28/ET - Severe (n=190,192,192)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nasal Irritation: screening - None (n=192,197,192)', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}]}, {'title': 'Nasal Irritationscreening Grade 1A (n=192,197,192)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Nasal Irritation screening Grade1B (n=192,197,192)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Nasal Irritationscreening Grade 2 (n=192,197,192)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nasal Irritation screening Grade 3 (n=192,197,192)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nasal Irritation screening Grade 4 (n=192,197,192)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nasal Irritation Day 28/ET None (n=190,192,192)', 'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}]}]}, {'title': 'Nasal Irritation Day 28/ETGrade 1A (n=190,192,192)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Nasal Irritation Day 28/ETGrade 1B (n=190,192,192)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Nasal Irritation Day 28/ETGrade 2 (n=190,192,192)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nasal Irritation Day 28/ETGrade 3 (n=190,192,192)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nasal Irritation Day 28/ETGrade 4 (n=190,192,192)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Edema: screening - None (n=192,197,192)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Edema: screening - Mild (n=192,197,192)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Edema: screening Moderate (n=192,197,192)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Edema: screening - Severe (n=192,197,192)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Edema: Day 28/ET None (n=190,192,192)', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Edema: Day 28/ET Mild (n=190,192,192)', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Edema: Day 28/ET Moderate (n=190,192,192)', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Edema: Day 28/ET Severe (n=190,192,192)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Nasal Discharge: screening - None (n=192,197,192)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}]}, {'title': 'Nasal Discharge: screening - Mild (n=192,197,192)', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}]}, {'title': 'Nasal Discharge:screening Moderate (n=192,197,192)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}]}, {'title': 'Nasal Discharge: screening Severe (n=192,197,192)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Nasal Discharge:Day 28/ET None (n=190,192,192)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}]}, {'title': 'Nasal Discharge:Day 28/ET Mild (n=190,192,192)', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}]}, {'title': 'Nasal Discharge:Day 28/ET Moderate (n=190,192,192)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}, {'title': 'Nasal Discharge:Day 28/ET Severe (n=190,192,192)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Erythema screening None (n=192,197,192)', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Erythema screening Mild (n=192,197,192)', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Erythema screeningModerate (n=192,197,192)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Erythema screening Severe (n=192,197,192)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Erythema Day 28/ET None (n=190,192,192)', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Erythema Day 28/ET Mild (n=190,192,192)', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Erythema Day 28/ET Moderate (n=190,192,192', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Erythema Day 28/ET Severe (n=190,192,192)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Bleeding: screening None (n=192,197,192)', 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Bleeding: screening Mild (n=192,197,192)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Bleedingscreening Moderate (n=192,197,192)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Bleeding screening Severe (n=192,197,192)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Bleeding: Day 28/ET None (n=190,192,192)', 'categories': [{'measurements': [{'value': '189', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Bleeding: Day 28/ET Mild (n=190,192,192)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Bleeding Day 28/ETModerate (n=190,192,192)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Mucosal Bleeding: Day 28/ET Severe (n=190,192,192)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Crusting of Mucosa: screening None (n=192,197,192)', 'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}]}]}, {'title': 'Crusting of Mucosa: screening Mild (n=192,197,192)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'CrustingofMucosa screening Moderate(n=192,197,192)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Crusting of Mucosa screening Severe(n=192,197,192)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Crusting of Mucosa:Day 28/ET None (n=190,192,192)', 'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}]}]}, {'title': 'Crusting of Mucosa:Day 28/ET Mild (n=190,192,192)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'CrustingofMucosaDay 28/ET Moderate (n=190,192,192)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Crusting of Mucosa:Day 28/ET Severe(n=190,192,192)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Conjuntival screening None (n=192,197,192)', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}]}]}, {'title': 'Conjuntival screening Mild (n=192,197,192)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}]}, {'title': 'Conjuntival screening Moderate n=(192,192, 192)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Conjuntival screeningSevere(n=192,197,192)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Conjuntival Day 28/ET None(n=190,192,192)', 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}]}, {'title': 'Conjuntival Day 28/ET Mild(n=190,192,192)', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': 'Conjuntival Day 28/ET Moderate(n=190,192)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Conjuntival Day 28/ET Severe (n=190,192, 192)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Erythmatous TM: screening None (n=192,197,192)', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '185', 'groupId': 'OG002'}]}]}, {'title': 'Erythmatous TM: screening Mild (n=192,197,192)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Erythmatous TM: screening Moderate(n=192,197,192)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Erythmatous TM:screening Severe (n=192,197,192)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Erythmatous TM: Day 28/ET None (n=190,192, 192)', 'categories': [{'measurements': [{'value': '179', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}]}, {'title': 'Erythmatous TM: Day 28/ET Mild (n=190,192, 192)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Erythmatous TM: Day 28/ET Moderate (n=190,192,192)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Erythmatous TM: Day 28/ET Severe (n=190,192, 192)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Lymphadenopathy: screening None (n=192,197,192)', 'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}]}, {'title': 'Lymphadenopathy: screening Mild (n=192,197,192)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Lymphadenopathy:screening Moderate (n=192,197,192)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Lymphadenopathy:screening Severe (n=192,197,192)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lymphadenopathy: Day 28/ET None (n=190,192, 192)', 'categories': [{'measurements': [{'value': '184', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}]}, {'title': 'Lymphadenopathy: Day 28/ET Mild (n=190,192, 192)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Lymphadenopathy Day 28/ET Moderate (n=190,192,192)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lymphadenopathy: Day 28/ET Severe ( n=190,192,192)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline and 28 days', 'description': 'Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks'}, {'id': 'FG001', 'title': 'Astepro 0.1%', 'description': '0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks'}, {'id': 'FG002', 'title': 'Astepro 0.15%', 'description': '0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '192'}, {'comment': '3 subjects were randomized in error', 'groupId': 'FG001', 'numSubjects': '197'}, {'groupId': 'FG002', 'numSubjects': '192'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '180'}, {'groupId': 'FG002', 'numSubjects': '180'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First Observation: February 5, 2007 Last Observation: October 8, 2007', 'preAssignmentDetails': 'Subjects participated in a 7 day screening period to Identify appropriate subjects based on symptom scores.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}, {'value': '578', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks'}, {'id': 'BG001', 'title': 'Astepro 0.1%', 'description': '0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks'}, {'id': 'BG002', 'title': 'Astepro 0.15%', 'description': '0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}, {'value': '514', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants based on ITT population', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.1', 'spread': '15.37', 'groupId': 'BG000'}, {'value': '36.9', 'spread': '13.09', 'groupId': 'BG001'}, {'value': '35.6', 'spread': '13.31', 'groupId': 'BG002'}, {'value': '36.9', 'spread': '13.97', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Number of participants based on ITT population', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}, {'value': '393', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '185', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants based on ITT population', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}, {'value': '578', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants based on ITT population', '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': 581}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'lastUpdateSubmitDate': '2011-06-06', 'studyFirstSubmitDate': '2008-07-08', 'resultsFirstSubmitDate': '2009-09-30', 'studyFirstSubmitQcDate': '2008-07-09', 'lastUpdatePostDateStruct': {'date': '2011-06-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-12-10', 'studyFirstPostDateStruct': {'date': '2008-07-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.', 'timeFrame': 'baseline and 28 days', 'description': 'Reflective total nasal symptom score consisting of Runny nose, itchy nose, nasal Congestion, and Sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day\n\nLeast square means (LS Mean) was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days', 'timeFrame': 'baseline and 28 days', 'description': 'instantaneous (subjects rate how they feel "right now") total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.'}, {'measure': 'Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days', 'timeFrame': 'baseline and 28 days', 'description': 'Reflective secondary symptom complex scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.'}, {'measure': 'Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days', 'timeFrame': 'baseline and 28 Days', 'description': 'A 28-item RQLQ was completed on Day 1 and Day 28 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.'}, {'measure': 'Change From Baseline on Direct Visual Nasal Exams and 28 Days', 'timeFrame': 'baseline and 28 days', 'description': 'Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Perennial Allergic Rhinitis']}, 'referencesModule': {'references': [{'pmid': '37920410', 'type': 'DERIVED', 'citation': 'Bousquet J, Klimek L, Kuhl HC, Nguyen DT, Ramalingam RK, Canonica GW, Berger WE. A double-blind, placebo-controlled trial of the efficacy and safety of two doses of azelastine hydrochloride in perennial allergic rhinitis. Front Allergy. 2023 Oct 18;4:1244012. doi: 10.3389/falgy.2023.1244012. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if two allergy medications are more effective than placebo.'}, '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\n* Must be in generally good health\n* Must meet minimum symptom requirements, as specified in protocol\n* Must be willing and able to provide informed consent and participate in all study procedures\n* 2-year history of PAR\n* Positive skin test to cockroach, dust mite, mold or cat/dog dander\n\nExclusion Criteria:\n\n* On nasal examination, presence of any nasal mucosal erosion, nasal ulceration or nasal septal perforation at the screening or randomization visit\n* Nasal diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, significant polyposis or nasal structural abnormalities\n* Nasal surgery or sinus surgery within the previous year\n* The use of any investigational drug within 30 days\n* Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose\n* Women who are pregnant or nursing\n* Women of child-bearing potential who are not abstinent and not practicing a medically acceptable method of contraception\n* Respiratory tract infection within 2 weeks of screening\n* Respiratory tract infections requiring oral antibiotic treatment within 2 weeks of screening\n* Patients with asthma with the exception of mild, intermittent\n* Significant pulmonary disease including COPD\n* Patients with arrhythmia\n* Patients with a known history of alcohol or drug abuse\n* Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor may significantly alter the absorption, distribution, metabolism or excretion of study drug.\n* Clinically relevant abnormal physical findings within one week of randomization\n* Overnight abscences from home for more than 3 nights\n* Employees of the research center or private practice and family members are excluded\n* Patients who received prohibited medications within specified timepoints in protocol.'}, 'identificationModule': {'nctId': 'NCT00712920', 'briefTitle': 'A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Meda Pharmaceuticals'}, 'officialTitle': 'Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 and MP03-33 in Patients With Perennial Allergic Rhinitis', 'orgStudyIdInfo': {'id': 'MP434'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '0.15% azelastine hydrochloride 1644 mcg/2 sprays per nostril 2 times a day for 4 weeks', 'interventionNames': ['Drug: 0.15% azelastine hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': '0.1% azelastine hydrochloride 1096 mcg/2 sprays per nostril 2 times a day for 4 weeks', 'interventionNames': ['Drug: 0.1% azelastine hydrochloride']}], 'interventions': [{'name': '0.15% azelastine hydrochloride', 'type': 'DRUG', 'description': '0.15% azelastine hydrochloride 1644 mcg', 'armGroupLabels': ['2']}, {'name': '0.1% azelastine hydrochloride', 'type': 'DRUG', 'description': '0.1% azelastine hydrochloride 1096 mcg', 'armGroupLabels': ['3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Allergy and Asthma Specialist Medical Group', 'geoPoint': {'lat': 33.6603, 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