Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-02-23 @ 9:22 PM
Study NCT ID:
NCT01279057
Status:
COMPLETED
Last Update Posted:
2021-02-03
First Post:
2011-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}, {'id': 'D012220', 'term': 'Rhinitis'}], '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': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C523187', 'term': 'fluticasone furoate'}, {'id': 'D000068298', 'term': 'Fluticasone'}], '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': 'Novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of randomized treatment until last dose plus 1-4 days (up to Day 15 + 3).', 'description': 'Any signs or symptoms that occurs during randomized treatment period plus the 1-4 days post treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Test', 'description': 'Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.', 'otherNumAtRisk': 288, 'deathsNumAtRisk': 288, 'otherNumAffected': 6, 'seriousNumAtRisk': 288, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Reference', 'description': 'Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.', 'otherNumAtRisk': 292, 'deathsNumAtRisk': 292, 'otherNumAffected': 4, 'seriousNumAtRisk': 292, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo nasal spray administered once daily for 14 days.', 'otherNumAtRisk': 147, 'deathsNumAtRisk': 147, 'otherNumAffected': 4, 'seriousNumAtRisk': 147, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 292, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'PRIMARY: Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Equivalence: Per-Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test', 'description': 'Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.'}, {'id': 'OG001', 'title': 'Reference', 'description': 'Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.036', 'spread': '2.415', 'groupId': 'OG000'}, {'value': '1.904', 'spread': '2.409', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio Test/Ref. Least Squares (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '104.085', 'ciLowerLimit': '87.421', 'ciUpperLimit': '124.210', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'If the 90% confidence intervals were contained within the interval 80.0% to 125.0%, then the two products were considered to be therapeutically equivalent.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 14 days', 'description': 'Patients were required to record a 12 hour "reflective" score twice a day approximately 12 hours apart. For the rTNSS patients were asked to "look back" or "reflect" on their severity of nasal symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms.\n\nMean baseline rTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period.\n\nMean change from baseline was calculated as "mean baseline rTNSS" - "mean post-randomization rTNSS". A positive change from baseline in rTNSS is considered a favorable outcome.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol population was used in this analysis. To determine equivalence, only the test and reference treatment arms were analyzed.'}, {'type': 'PRIMARY', 'title': 'PRIMARY: Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Superiority: Intent-to-Treat Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test', 'description': 'Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.'}, {'id': 'OG001', 'title': 'Reference', 'description': 'Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo nasal spray administered once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.035', 'spread': '2.362', 'groupId': 'OG000'}, {'value': '1.845', 'spread': '2.378', 'groupId': 'OG001'}, {'value': '0.952', 'spread': '1.842', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0001', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 14 days', 'description': 'Patients were required to record a 12 hour "reflective" score twice a day approximately 12 hours apart. For the rTNSS patients were asked to "look back" or "reflect" on their severity of nasal symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms.\n\nMean baseline rTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period.\n\nMean change from baseline was calculated as "mean baseline rTNSS" - "mean post-randomization rTNSS". A positive change from baseline in rTNSS is considered a favorable outcome.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population including participants with valid measurements for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Equivalence: Per-Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test', 'description': 'Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.'}, {'id': 'OG001', 'title': 'Reference', 'description': 'Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.017', 'spread': '2.439', 'groupId': 'OG000'}, {'value': '1.854', 'spread': '2.411', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio Test/Ref. LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '106.635', 'ciLowerLimit': '89.256', 'ciUpperLimit': '127.790', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '90% confidence intervals within the interval 80.0% to 125.0%.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 14 days', 'description': 'Participants were required to record an "instantaneous" score twice a day approximately 12 hours apart. For the iTNSS participants were asked to evaluate "how I feel now" regarding their severity of nasal symptoms. The first rating on each day was taken prior to dosing. Participants were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean iTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms.\n\nMean baseline iTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period.\n\nMean change from baseline was calculated as "mean baseline iTNSS" - "mean post-randomization iTNSS". A positive change from baseline in iTNSS is considered a favorable outcome.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol population was used in this analysis. To determine equivalence, only the test and reference treatment arms were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Superiority: Intent-to-Treat Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test', 'description': 'Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.'}, {'id': 'OG001', 'title': 'Reference', 'description': 'Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo nasal spray administered once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.994', 'spread': '2.398', 'groupId': 'OG000'}, {'value': '1.805', 'spread': '2.398', 'groupId': 'OG001'}, {'value': '0.846', 'spread': '1.981', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 14 days', 'description': 'Participants were required to record an "instantaneous" score twice a day approximately 12 hours apart. For the iTNSS participants were asked to evaluate "how I feel now" regarding their severity of nasal symptoms. The first rating on each day was taken prior to dosing. Participants were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean iTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms.\n\nMean baseline iTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period.\n\nMean change from baseline was calculated as "mean baseline iTNSS" - "mean post-randomization iTNSS". A positive change from baseline in iTNSS is considered a favorable outcome.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population including participants with valid measurements for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS) (Equivalence: Per-Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test', 'description': 'Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.'}, {'id': 'OG001', 'title': 'Reference', 'description': 'Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.388', 'spread': '1.831', 'groupId': 'OG000'}, {'value': '1.152', 'spread': '1.790', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio Test/Ref. LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '115.877', 'ciLowerLimit': '94.129', 'ciUpperLimit': '143.949', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '90% confidence intervals within the interval 80.0% to 125.0%.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 14 days', 'description': 'Patients were required to record a 12 hour "reflective" score twice a day approximately 12 hours apart. For the rTOSS patients were asked to "look back" or "reflect" on their severity of ocular symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 3 ocular symptoms (eye redness, itching/burning eyes, and tearing/watering eyes) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 3 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTOSS, which ranged from 0 to 9 with a lower score indicating less severe symptoms.\n\nMean baseline rTOSS was calculated by summing the means of the 3 individual symptom scores obtained over the 72 hours before the randomized treatment period.\n\nMean change from baseline was calculated as "mean baseline rTOSS" - "mean post-randomization rTOSS". A positive change from baseline is considered a favorable outcome.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol population was used in this analysis. To determine equivalence, only the test and reference treatment arms were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS) (Superiority: Intent-to-Treat Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test', 'description': 'Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.'}, {'id': 'OG001', 'title': 'Reference', 'description': 'Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo nasal spray administered once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.373', 'spread': '1.795', 'groupId': 'OG000'}, {'value': '1.128', 'spread': '1.762', 'groupId': 'OG001'}, {'value': '0.787', 'spread': '1.527', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0018', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0441', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 14 days', 'description': 'Patients were required to record a 12 hour "reflective" score twice a day approximately 12 hours apart. For the rTOSS patients were asked to "look back" or "reflect" on their severity of ocular symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 3 ocular symptoms (eye redness, itching/burning eyes, and tearing/watering eyes) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 3 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTOSS, which ranged from 0 to 9 with a lower score indicating less severe symptoms.\n\nMean baseline rTOSS was calculated by summing the means of the 3 individual symptom scores obtained over the 72 hours before the randomized treatment period.\n\nMean change from baseline was calculated as "mean baseline rTOSS" - "mean post-randomization rTOSS". A positive change from baseline is considered a favorable outcome.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population including participants with valid measurements for the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Instantaneous Total Ocular Symptom Score (iTOSS) (Equivalence: Per-Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test', 'description': 'Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.'}, {'id': 'OG001', 'title': 'Reference', 'description': 'Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.389', 'spread': '1.884', 'groupId': 'OG000'}, {'value': '1.135', 'spread': '1.803', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio Test/Ref. LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '117.712', 'ciLowerLimit': '95.410', 'ciUpperLimit': '146.583', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '90% confidence intervals within the interval 80.0% to 125.0%.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 14 days', 'description': 'Patients were required to record an "instantaneous" score twice a day approximately 12 hours apart. For the iTOSS patients were asked to evaluate "how I feel now" regarding their severity of ocular symptoms. The first rating on each day was taken prior to dosing. Patients were asked to score 3 ocular symptoms (eye redness, itching/burning eyes, and tearing/watering eyes) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 3 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTOSS, which ranged from 0 to 9 with a lower score indicating less severe symptoms.\n\nMean baseline rTOSS was calculated by summing the means of the 3 individual symptom scores obtained over the 72 hours before the randomized treatment period.\n\nMean change from baseline was calculated as "mean baseline iTOSS" - "mean post-randomization iTOSS". A positive change from baseline in iTOSS is considered a favorable outcome.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol population was used in this analysis. To determine equivalence, only the test and reference treatment arms were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Instantaneous Total Ocular Symptom Score (iTOSS) (Superiority: Intent-to-Treat Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test', 'description': 'Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.'}, {'id': 'OG001', 'title': 'Reference', 'description': 'Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo nasal spray administered once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.362', 'spread': '1.851', 'groupId': 'OG000'}, {'value': '1.118', 'spread': '1.784', 'groupId': 'OG001'}, {'value': '0.787', 'spread': '1.563', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0018', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0451', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 14 days', 'description': 'Patients were required to record an "instantaneous" score twice a day approximately 12 hours apart. For the iTOSS patients were asked to evaluate "how I feel now" regarding their severity of ocular symptoms. The first rating on each day was taken prior to dosing. Patients were asked to score 3 ocular symptoms (eye redness, itching/burning eyes, and tearing/watering eyes) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 3 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTOSS, which ranged from 0 to 9 with a lower score indicating less severe symptoms.\n\nMean baseline rTOSS was calculated by summing the means of the 3 individual symptom scores obtained over the 72 hours before the randomized treatment period.\n\nMean change from baseline was calculated as "mean baseline iTOSS" - "mean post-randomization iTOSS". A positive change from baseline in iTOSS is considered a favorable outcome.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population including participants with valid measurements for the outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test', 'description': 'Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.'}, {'id': 'FG001', 'title': 'Reference', 'description': 'Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo nasal spray administered once daily for 14 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '288'}, {'groupId': 'FG001', 'numSubjects': '292'}, {'groupId': 'FG002', 'numSubjects': '147'}]}, {'type': 'Per-Protocol (PPP) Population', 'comment': 'All participants who satisfied the criteria set forth in the protocol in terms of dosing compliance, number of available post-randomization evaluations and absence of significant protocol violations.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '257'}, {'groupId': 'FG001', 'numSubjects': '245'}, {'groupId': 'FG002', 'numSubjects': '126'}]}, {'type': 'Intent-to-Treat (ITT) Population', 'comment': 'All participants in the PPP as well as all participants who administered at least one dose of randomized study drug and had at least one post-randomization evaluation.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '284'}, {'groupId': 'FG001', 'numSubjects': '285'}, {'groupId': 'FG002', 'numSubjects': '144'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '282'}, {'groupId': 'FG001', 'numSubjects': '287'}, {'groupId': 'FG002', 'numSubjects': '144'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Insufficient therapeutic response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Restricted medication for seasonal allergic rhinitis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in 10 investigative sites in 1 country.', 'preAssignmentDetails': 'Participants who met the inclusion/exclusion criteria entered a 7-day placebo lead-in period. Following this placebo lead-in period, on Day 1 participants who continued to meet eligibility criteria were randomly assigned in a 2:2:1 ratio to one of three treatment groups (Test Product:Reference Product:Placebo).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'BG000'}, {'value': '292', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}, {'value': '727', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Test', 'description': 'Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.'}, {'id': 'BG001', 'title': 'Reference', 'description': 'Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo nasal spray administered once daily for 14 days.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '< 18', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}, {'title': '18 - 40', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '320', 'groupId': 'BG003'}]}, {'title': '41 - 64', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '318', 'groupId': 'BG003'}]}, {'title': '65 - 75', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}, {'title': '> 75', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '460', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '267', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '233', 'groupId': 'BG000'}, {'value': '241', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}, {'value': '600', 'groupId': 'BG003'}]}, {'title': 'Black/African American', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian / Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'American Indian / Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': 727}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'dispFirstSubmitDate': '2012-08-10', 'completionDateStruct': {'date': '2011-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-14', 'studyFirstSubmitDate': '2011-01-17', 'dispFirstSubmitQcDate': '2012-12-14', 'resultsFirstSubmitDate': '2021-01-14', 'studyFirstSubmitQcDate': '2011-01-18', 'dispFirstPostDateStruct': {'date': '2012-12-19', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-14', 'studyFirstPostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PRIMARY: Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Equivalence: Per-Protocol Population)', 'timeFrame': 'Baseline, 14 days', 'description': 'Patients were required to record a 12 hour "reflective" score twice a day approximately 12 hours apart. For the rTNSS patients were asked to "look back" or "reflect" on their severity of nasal symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms.\n\nMean baseline rTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period.\n\nMean change from baseline was calculated as "mean baseline rTNSS" - "mean post-randomization rTNSS". A positive change from baseline in rTNSS is considered a favorable outcome.'}, {'measure': 'PRIMARY: Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Superiority: Intent-to-Treat Population)', 'timeFrame': 'Baseline, 14 days', 'description': 'Patients were required to record a 12 hour "reflective" score twice a day approximately 12 hours apart. For the rTNSS patients were asked to "look back" or "reflect" on their severity of nasal symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms.\n\nMean baseline rTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period.\n\nMean change from baseline was calculated as "mean baseline rTNSS" - "mean post-randomization rTNSS". A positive change from baseline in rTNSS is considered a favorable outcome.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Equivalence: Per-Protocol Population)', 'timeFrame': 'Baseline, 14 days', 'description': 'Participants were required to record an "instantaneous" score twice a day approximately 12 hours apart. For the iTNSS participants were asked to evaluate "how I feel now" regarding their severity of nasal symptoms. The first rating on each day was taken prior to dosing. Participants were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean iTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms.\n\nMean baseline iTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period.\n\nMean change from baseline was calculated as "mean baseline iTNSS" - "mean post-randomization iTNSS". A positive change from baseline in iTNSS is considered a favorable outcome.'}, {'measure': 'Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Superiority: Intent-to-Treat Population)', 'timeFrame': 'Baseline, 14 days', 'description': 'Participants were required to record an "instantaneous" score twice a day approximately 12 hours apart. For the iTNSS participants were asked to evaluate "how I feel now" regarding their severity of nasal symptoms. The first rating on each day was taken prior to dosing. Participants were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean iTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms.\n\nMean baseline iTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period.\n\nMean change from baseline was calculated as "mean baseline iTNSS" - "mean post-randomization iTNSS". A positive change from baseline in iTNSS is considered a favorable outcome.'}, {'measure': 'Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS) (Equivalence: Per-Protocol Population)', 'timeFrame': 'Baseline, 14 days', 'description': 'Patients were required to record a 12 hour "reflective" score twice a day approximately 12 hours apart. For the rTOSS patients were asked to "look back" or "reflect" on their severity of ocular symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 3 ocular symptoms (eye redness, itching/burning eyes, and tearing/watering eyes) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 3 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTOSS, which ranged from 0 to 9 with a lower score indicating less severe symptoms.\n\nMean baseline rTOSS was calculated by summing the means of the 3 individual symptom scores obtained over the 72 hours before the randomized treatment period.\n\nMean change from baseline was calculated as "mean baseline rTOSS" - "mean post-randomization rTOSS". A positive change from baseline is considered a favorable outcome.'}, {'measure': 'Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS) (Superiority: Intent-to-Treat Population)', 'timeFrame': 'Baseline, 14 days', 'description': 'Patients were required to record a 12 hour "reflective" score twice a day approximately 12 hours apart. For the rTOSS patients were asked to "look back" or "reflect" on their severity of ocular symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 3 ocular symptoms (eye redness, itching/burning eyes, and tearing/watering eyes) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 3 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTOSS, which ranged from 0 to 9 with a lower score indicating less severe symptoms.\n\nMean baseline rTOSS was calculated by summing the means of the 3 individual symptom scores obtained over the 72 hours before the randomized treatment period.\n\nMean change from baseline was calculated as "mean baseline rTOSS" - "mean post-randomization rTOSS". A positive change from baseline is considered a favorable outcome.'}, {'measure': 'Mean Change From Baseline in Instantaneous Total Ocular Symptom Score (iTOSS) (Equivalence: Per-Protocol Population)', 'timeFrame': 'Baseline, 14 days', 'description': 'Patients were required to record an "instantaneous" score twice a day approximately 12 hours apart. For the iTOSS patients were asked to evaluate "how I feel now" regarding their severity of ocular symptoms. The first rating on each day was taken prior to dosing. Patients were asked to score 3 ocular symptoms (eye redness, itching/burning eyes, and tearing/watering eyes) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 3 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTOSS, which ranged from 0 to 9 with a lower score indicating less severe symptoms.\n\nMean baseline rTOSS was calculated by summing the means of the 3 individual symptom scores obtained over the 72 hours before the randomized treatment period.\n\nMean change from baseline was calculated as "mean baseline iTOSS" - "mean post-randomization iTOSS". A positive change from baseline in iTOSS is considered a favorable outcome.'}, {'measure': 'Mean Change From Baseline in Instantaneous Total Ocular Symptom Score (iTOSS) (Superiority: Intent-to-Treat Population)', 'timeFrame': 'Baseline, 14 days', 'description': 'Patients were required to record an "instantaneous" score twice a day approximately 12 hours apart. For the iTOSS patients were asked to evaluate "how I feel now" regarding their severity of ocular symptoms. The first rating on each day was taken prior to dosing. Patients were asked to score 3 ocular symptoms (eye redness, itching/burning eyes, and tearing/watering eyes) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 3 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTOSS, which ranged from 0 to 9 with a lower score indicating less severe symptoms.\n\nMean baseline rTOSS was calculated by summing the means of the 3 individual symptom scores obtained over the 72 hours before the randomized treatment period.\n\nMean change from baseline was calculated as "mean baseline iTOSS" - "mean post-randomization iTOSS". A positive change from baseline in iTOSS is considered a favorable outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rhinitis', 'Seasonal Allergic Rhinitis', 'Fluticasone furoate', 'Equivalence', 'Hay fever'], 'conditions': ['Rhinitis, Allergic, Seasonal']}, 'descriptionModule': {'briefSummary': 'This study compared the safety and efficacy of a generic fluticasone furoate (Lek Pharmaceuticals) nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations were tested for superiority against a placebo nasal spray.', 'detailedDescription': 'The study was designed as a double-blind, randomized, placebo-controlled, parallel group, multi-site to compare the clinical equivalence of the test formulation of fluticasone furoate, 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals d.d.) with the reference formulation Veramyst® nasal spray (GlaxoSmithKline) in the relief of the signs and symptoms of seasonal allergic rhinitis. Participants who met the inclusion/exclusion criteria entered a 7-day placebo lead-in period. Following this placebo lead-in period, on Day 1 participants who continued to meet eligibility criteria were randomly assigned in a 2:2:1 ratio to one of three treatment groups (Test Product:Reference Product:Placebo) for 14 days of treatment. In all treatment groups, participants were instructed to administer the study drug once daily at approximately the same time each day. A single dose of 110 mcg was 4 actuations, each containing 27.5 mcg per actuation. Patients were instructed to administer the 4 actuations alternating between right and left nostril, such that 2 actuations were not administered back to back to the same nostril.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or non-pregnant, non-lactating female 12 years of age or older with a minimum of 2 years of previous history of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.\n* Signed informed consent (assent) form.\n* Documented positive allergic skin test to local pollen.\n* An average score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) with a minimum score of at least 2 for "nasal congestion" and at least 4 on the reflective Total Ocular Symptom Score (rTOSS).\n\nExclusion Criteria:\n\n* History of asthma that required chronic therapy (with the exception of occasional acute or mild exercise induced asthma).\n* Some other past and concomitant medical conditions, prohibited medications.\n* Upper respiratory tract infection or any untreated infections.\n* Patient has started immunotherapy/changed the dose.\n* Any known allergy to any of the components of the study nasal spray.'}, 'identificationModule': {'nctId': 'NCT01279057', 'briefTitle': 'A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sandoz'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi-Site Study to Compare the Clinical Equivalence of Fluticasone Furoate Nasal Spray (Lek Pharmaceuticals) With Veramyst® Nasal Spray (GlaxoSmithKline) in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis', 'orgStudyIdInfo': {'id': '71047201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test', 'description': 'Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.', 'interventionNames': ['Drug: Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference', 'description': 'Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.', 'interventionNames': ['Drug: Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo nasal spray administered once daily for 14 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals)', 'type': 'DRUG', 'description': 'Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.', 'armGroupLabels': ['Test']}, {'name': 'Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray', 'type': 'DRUG', 'description': 'Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.', 'armGroupLabels': ['Reference']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo nasal spray administered once daily (4 actuations) for 14 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Sandoz Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78750', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Sandoz Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Sandoz Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78028', 'city': 'Kerrville', 'state': 'Texas', 'country': 'United States', 'facility': 'Sandoz Investigational Site', 'geoPoint': {'lat': 30.04743, 'lon': -99.14032}}, {'zip': '78130', 'city': 'New Braunfels', 'state': 'Texas', 'country': 'United States', 'facility': 'Sandoz Investigational Site', 'geoPoint': {'lat': 29.703, 'lon': -98.12445}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Sandoz Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '76712', 'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Sandoz Investigational Site', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sandoz', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}