Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT00997620
Status:
COMPLETED
Last Update Posted:
2018-05-18
First Post:
2009-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Fluticasone Furoate Treatment of Daytime Somnolence and Cognitive Performance in Seasonal Allergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}, {'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}], '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'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'immunman@westernskymed.com', 'phone': '915-544-2557', 'title': 'Lyndon E Mansfield, MD', 'organization': 'Westernsky'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo for comparison\n\nPlacebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fluticasone Furoate', 'description': 'Active treatment\n\nFluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for comparison\n\nPlacebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo'}, {'id': 'OG001', 'title': 'Fluticasone Furoate', 'description': 'Active treatment\n\nFluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.63', 'spread': '2.98', 'groupId': 'OG000'}, {'value': '3.95', 'spread': '3.18', 'groupId': 'OG001'}]}]}, {'title': 'After 2 weeks intervention', 'categories': [{'measurements': [{'value': '1.20', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '1.83', 'spread': '1.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'over 2 weeks', 'description': 'The outcomes measures for TOVA are errors of omission. Targets which were not identified. Errors of commission are when targets are identified incorrectly. Reaction time is reported as the average time in milliseconds for the responses. The results are reported as mean and standard deviation as baseline and after 2 weeks of intervention. The difference between the means was evaluated by paired t testing.', 'unitOfMeasure': 'number of errors', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Errors of Commission.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for comparison\n\nPlacebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo'}, {'id': 'OG001', 'title': 'Fluticasone Furoate', 'description': 'Active treatment\n\nFluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.33', 'spread': '4.54', 'groupId': 'OG000'}, {'value': '1.54', 'spread': '3.72', 'groupId': 'OG001'}]}]}, {'title': 'After 2 weeks intervention', 'categories': [{'measurements': [{'value': '5.75', 'spread': '14.10', 'groupId': 'OG000'}, {'value': '1.58', 'spread': '4.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after 2 weeks intervention', 'description': 'The outcomes measures for TOVA are errors of commission. Targets which were identified incorrectly. Targets which are not identified, errors of omission and average time of each target viewing.', 'unitOfMeasure': 'non identified targets', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Response Time for Targets.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for comparison\n\nPlacebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo'}, {'id': 'OG001', 'title': 'Fluticasone Furoate', 'description': 'Active treatment\n\nFluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '387.58', 'spread': '77.03', 'groupId': 'OG000'}, {'value': '363.38', 'spread': '61.91', 'groupId': 'OG001'}]}]}, {'title': 'After 2 weeks intervention', 'categories': [{'measurements': [{'value': '412.47', 'spread': '66.16', 'groupId': 'OG000'}, {'value': '391.81', 'spread': '91.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'over 2 weeks', 'description': 'The outcomes measures for TOVA are the length of time to respond to targets. The time function represents the average time spent in milliseconds spent on each target.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Epworth Sleep Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for comparison\n\nPlacebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo'}, {'id': 'OG001', 'title': 'Fluticasone Furoate', 'description': 'Active treatment\n\nFluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '13.28', 'spread': '3.42', 'groupId': 'OG000'}, {'value': '13.83', 'spread': '3.82', 'groupId': 'OG001'}]}]}, {'title': 'After 2 weeks intervention', 'categories': [{'measurements': [{'value': '12.80', 'spread': '4.10', 'groupId': 'OG000'}, {'value': '10.80', 'spread': '5.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< .05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.50', 'groupDescription': 'The statistical analysis was of t testing of the difference of the mean between the baseline and after two weeks. The power analysis was prior to data collection was not performed for this test. The null hypothesis is no different, no difference between placebo and active treatment.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and after 2 weeks intervention', 'description': 'The Epworth sleepiness scale measures is a validated test of daytime sleepiness which involved the subjects answering 8 questions. Each question is answered on a 0 - 3 scale with 3 being the most likely associated with drowsiness. The score is reported as a composite score of 8 questions, with a minimum score of 0 and a maximum score of 24. A higher composite score represents more likelihood of daytime sleepiness. It is administered between 1500 and 1700 daily.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Nasal Spray', 'description': 'One week placebo nasal spray followed by two weeks placebo nasal spray.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate Nasal Spray', 'description': 'One week placebo nasal spray followed by two weeks fluticasone furoate nasal spray.'}], 'classes': [{'title': 'Difficulty getting to sleep', 'categories': [{'measurements': [{'value': '-0.158', 'spread': '.384', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '0.326', 'groupId': 'OG001'}]}]}, {'title': 'Unable to get a good nights sleep', 'categories': [{'measurements': [{'value': '-0.579', 'spread': '0.369', 'groupId': 'OG000'}, {'value': '-0.904', 'spread': '0.389', 'groupId': 'OG001'}]}]}, {'title': 'Restless (tossing and turning)', 'categories': [{'measurements': [{'value': '-0.789', 'spread': '0.329', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '0.37', 'groupId': 'OG001'}]}]}, {'title': 'Having to get up because of stuffy nose.', 'categories': [{'measurements': [{'value': '-0.632', 'spread': '0.298', 'groupId': 'OG000'}, {'value': '1.49', 'spread': '3.01', 'groupId': 'OG001'}]}]}, {'title': 'Nasal congestion', 'categories': [{'measurements': [{'value': '-0.7894', 'spread': '0.329', 'groupId': 'OG000'}, {'value': '-0.76', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Sinus pressure or pain', 'categories': [{'measurements': [{'value': '-0.738', 'spread': '0.389', 'groupId': 'OG000'}, {'value': '1.569', 'spread': '4.2494', 'groupId': 'OG001'}]}]}, {'title': 'Runny nose', 'categories': [{'measurements': [{'value': '-0.895', 'spread': '0.252', 'groupId': 'OG000'}, {'value': '-0.429', 'spread': '0.405', 'groupId': 'OG001'}]}]}, {'title': 'Post-nasal drip', 'categories': [{'measurements': [{'value': '-1.2105', 'spread': '0.493', 'groupId': 'OG000'}, {'value': '-1.333', 'spread': '0.380', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '-1.105', 'spread': '0.431', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.576', 'groupId': 'OG001'}]}]}, {'title': 'Feel tired and unrefreshed', 'categories': [{'measurements': [{'value': '-1.158', 'spread': '0.448', 'groupId': 'OG000'}, {'value': '-0.286', 'spread': '0.962', 'groupId': 'OG001'}]}]}, {'title': 'Nasal congestion or stuffy nose', 'categories': [{'measurements': [{'value': '-0.684', 'spread': '0.380', 'groupId': 'OG000'}, {'value': '-0.857', 'spread': '0.340', 'groupId': 'OG001'}]}]}, {'title': 'Congestion in sinuses', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.354', 'groupId': 'OG000'}, {'value': '-1.048', 'spread': '0.297', 'groupId': 'OG001'}]}]}, {'title': 'time to clear nighttime drainage after waking', 'categories': [{'measurements': [{'value': '-0.474', 'spread': '0.299', 'groupId': 'OG000'}, {'value': '-1.190', 'spread': '0.418', 'groupId': 'OG001'}]}]}, {'title': 'Need to rub nose or eyes', 'categories': [{'measurements': [{'value': '-0.053', 'spread': '0.0291', 'groupId': 'OG000'}, {'value': '-1.4286', 'spread': '0.369', 'groupId': 'OG001'}]}]}, {'title': 'Have to take medication', 'categories': [{'measurements': [{'value': '-0.474', 'spread': '0.337', 'groupId': 'OG000'}, {'value': '-1.429', 'spread': '0.434', 'groupId': 'OG001'}]}]}, {'title': 'Having to avoid symptom triggers', 'categories': [{'measurements': [{'value': '-0.474', 'spread': '0.345', 'groupId': 'OG000'}, {'value': '-1.190', 'spread': '0.541', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'In nocturnal rhinoconjunctivitis quality of life questionnaire instrument to measure the effects of nasal disorder on nighttime sleep and awakening. It consists of 16 questions. The scale is from 0-6, 0 being not troubled and 6 reflecting extreme trouble. This survey is interpreted as a minimal clinically important difference of each question. A change of +/- 0.5 is a threshold of minimally important clinical difference. Higher value mean more disturbance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The NRQLQ values represent the average for each intervention.'}, {'type': 'SECONDARY', 'title': 'Nasal Symptom Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Nasal Spray', 'description': 'One week placebo nasal spray followed by two weeks placebo nasal spray'}, {'id': 'OG001', 'title': 'Fluticasone Furoate Nasal Spray', 'description': 'One week placebo nasal spray followed by two weeks fluticasone furoate nasal spray.'}], 'classes': [{'title': 'Instaneous Baseline', 'categories': [{'measurements': [{'value': '12.65', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '12.88', 'spread': '4.26', 'groupId': 'OG001'}]}]}, {'title': 'Instaneous Post 2 Weeks Therapy', 'categories': [{'measurements': [{'value': '13.74', 'spread': '4.52', 'groupId': 'OG000'}, {'value': '10.84', 'spread': '6.34', 'groupId': 'OG001'}]}]}, {'title': 'Reflective Baseline', 'categories': [{'measurements': [{'value': '13.53', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '12.99', 'spread': '3.73', 'groupId': 'OG001'}]}]}, {'title': 'Reflective Post 2 Weeks Therapy', 'categories': [{'measurements': [{'value': '14.02', 'spread': '4.65', 'groupId': 'OG000'}, {'value': '11.19', 'spread': '6.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Total nasal symptom score was measured AM and PM. The reflective scale measures subjective symptoms over the previous 12 hours. Instantaneous symptoms measure how subjects felt at the present time. The score consists of subjective perception of nasal congestion, rhinorrhea, nasal itching and sneezing. The scale for each symptom is 0 - not present, 1- mild (present but minimal), 2 - moderate (symptoms are bothersome but tolerable), 3 - severe (symptoms are not tolerable). The baseline value was the mean of the 7 day placebo run-in for the combined scores. This was calculated for the placebo group and the fluticasone group for both the instantaneous and the reflective scores. The intervention time utilized the same combined AM and PM reflective and instantaneous scoring. The data was analyzed using two sample t test comparison of the placebo vs fluticasone furoate group. Low value, less symptoms. High value, more symptoms. Minimum score is 0. Maximum score is 24.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo for comparison\n\nPlacebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo'}, {'id': 'FG001', 'title': 'Fluticasone Furoate', 'description': 'Active treatment\n\nFluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo for comparison\n\nPlacebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo'}, {'id': 'BG001', 'title': 'Fluticasone Furoate', 'description': 'Active treatment\n\nFluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '55'}, {'value': '38', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '55'}, {'value': '37', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '55'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-14', 'studyFirstSubmitDate': '2009-10-15', 'resultsFirstSubmitDate': '2017-03-15', 'studyFirstSubmitQcDate': '2009-10-16', 'lastUpdatePostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-14', 'studyFirstPostDateStruct': {'date': '2009-10-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance', 'timeFrame': 'over 2 weeks', 'description': 'The outcomes measures for TOVA are errors of omission. Targets which were not identified. Errors of commission are when targets are identified incorrectly. Reaction time is reported as the average time in milliseconds for the responses. The results are reported as mean and standard deviation as baseline and after 2 weeks of intervention. The difference between the means was evaluated by paired t testing.'}, {'measure': 'Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Errors of Commission.', 'timeFrame': 'after 2 weeks intervention', 'description': 'The outcomes measures for TOVA are errors of commission. Targets which were identified incorrectly. Targets which are not identified, errors of omission and average time of each target viewing.'}, {'measure': 'Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Response Time for Targets.', 'timeFrame': 'over 2 weeks', 'description': 'The outcomes measures for TOVA are the length of time to respond to targets. The time function represents the average time spent in milliseconds spent on each target.'}], 'secondaryOutcomes': [{'measure': 'Change in Epworth Sleep Scale', 'timeFrame': 'Baseline and after 2 weeks intervention', 'description': 'The Epworth sleepiness scale measures is a validated test of daytime sleepiness which involved the subjects answering 8 questions. Each question is answered on a 0 - 3 scale with 3 being the most likely associated with drowsiness. The score is reported as a composite score of 8 questions, with a minimum score of 0 and a maximum score of 24. A higher composite score represents more likelihood of daytime sleepiness. It is administered between 1500 and 1700 daily.'}, {'measure': 'Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire', 'timeFrame': '2 weeks', 'description': 'In nocturnal rhinoconjunctivitis quality of life questionnaire instrument to measure the effects of nasal disorder on nighttime sleep and awakening. It consists of 16 questions. The scale is from 0-6, 0 being not troubled and 6 reflecting extreme trouble. This survey is interpreted as a minimal clinically important difference of each question. A change of +/- 0.5 is a threshold of minimally important clinical difference. Higher value mean more disturbance.'}, {'measure': 'Nasal Symptom Scores', 'timeFrame': '2 weeks', 'description': 'Total nasal symptom score was measured AM and PM. The reflective scale measures subjective symptoms over the previous 12 hours. Instantaneous symptoms measure how subjects felt at the present time. The score consists of subjective perception of nasal congestion, rhinorrhea, nasal itching and sneezing. The scale for each symptom is 0 - not present, 1- mild (present but minimal), 2 - moderate (symptoms are bothersome but tolerable), 3 - severe (symptoms are not tolerable). The baseline value was the mean of the 7 day placebo run-in for the combined scores. This was calculated for the placebo group and the fluticasone group for both the instantaneous and the reflective scores. The intervention time utilized the same combined AM and PM reflective and instantaneous scoring. The data was analyzed using two sample t test comparison of the placebo vs fluticasone furoate group. Low value, less symptoms. High value, more symptoms. Minimum score is 0. Maximum score is 24.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hay Fever', 'Daytime somnolence', 'Cognition'], 'conditions': ['Seasonal Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'The hypothesis is that treating hay fever patients who had daytime sleepiness and slowed thinking because of the hay fever will improve when treated with an effective anti-hay fever medication, an intranasal steroid, that is will have less daytime sleepiness and demonstrate better thinking.', 'detailedDescription': 'In this study of patients with seasonal allergic rhinitis we will monitor daytime sleepiness as measured by validated daytime sleep score (Eppworth Daytime Sleepiness Scale) and cognitive performance weekly as measured by a validated test of cognitive performance (TOVA). The treatment group with intervention of fluticasone furoate nasal spray 110 mcg two sprays in each nostril once daily will be compared to a placebo treated group of similar subjects with seasonal allergic rhinitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic seasonal allergic rhinitis symptoms for at least 2 years at the time of study in the season of the study.\n* Allergy skin tests positive for the airborne allergens present at the study time within the past 12 months.\n* A score of 2 or more on the NRQLQ of the Rhinitis Quality of LIfe Questionnaire.\n* Active allergic rhinitis on 4 of 7 days during run-in week, and evidence on sleep scales of drowsiness on 3 of 7 days.\n* Ability to read, understand and give informed consent.\n* Ability to understand and carry out responsibilities of the study\n\nExclusion Criteria:\n\n* Any chronic disease or other acute disease, which could influence central nervous system.\n* The use of any medication, which could affect central nervous system function.\n* Unwillingness to participate in the study.\n* Inability to understand testing procedures or use of medication.\n* Hypersensitivity to fluticasone or vehicle of nasal sprays.\n* Any sleep disorders including obstructive sleep apnea.'}, 'identificationModule': {'nctId': 'NCT00997620', 'briefTitle': 'Fluticasone Furoate Treatment of Daytime Somnolence and Cognitive Performance in Seasonal Allergic Rhinitis', 'organization': {'class': 'OTHER', 'fullName': 'Western Sky Medical Research'}, 'officialTitle': 'A Double Blind, Placebo Controlled Randomized Trial Evaluating the Effects of Fluticasone Nasal Spray in Subjects With Seasonal Allergic Rhinitis and a History of Sleep Disturbance on Cognitive Performance and Daytime Sleepiness', 'orgStudyIdInfo': {'id': '2008-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo treatment given as a once daily dose intranasally.in subjects with active seasonal allergic rhinitis.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Fluticasone Furoate', 'description': 'IFluticasone Furoate 110 mcg given intranasly once daily in am as an active treatment of seasonal allergic rhinitis', 'interventionNames': ['Drug: Fluticasone furoate Nasal Spray 110 mcg']}], 'interventions': [{'name': 'Fluticasone furoate Nasal Spray 110 mcg', 'type': 'DRUG', 'otherNames': ['Fluticasone Furoate Nasal Spray'], 'description': 'Fluticasone fuorate nasal spray 110 mcg 2 sprays each nostril am will be compared to similar appearing placebo given 2 sprays each nostril am. The subjects will receive one week placebo nasal spray to establish a baseline then they will then be switched to a nasal spray of fluticasone furoate 110 mcg once daily and continue the evaluations.', 'armGroupLabels': ['Fluticasone Furoate']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo Veramyst Nasal Spray'], 'description': 'Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo. The subjects will receive one week placebo nasal spray to establish a baseline then they will then be switched to a nasal spray of Placebo once daily and continue the evaluations.', 'armGroupLabels': ['Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This a single study site and at end IPD will be used in analyis by PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western Sky Medical Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Lyndon Mansfield', 'investigatorAffiliation': 'Western Sky Medical Research'}}}}