Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-28 @ 1:46 AM
Study NCT ID:
NCT00118703
Status:
COMPLETED
Last Update Posted:
2017-08-21
First Post:
2005-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Once-Daily Investigational Nasal Spray In Adults And Adolescents With Vasomotor Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012223', 'term': 'Rhinitis, Vasomotor'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from on or after the randomization date (Up to Day 34).', 'description': 'ITT Population was used.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.', 'otherNumAtRisk': 173, 'deathsNumAtRisk': 173, 'otherNumAffected': 38, 'seriousNumAtRisk': 173, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fluticasone Furoate 110 µg QD', 'description': 'Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.', 'otherNumAtRisk': 174, 'deathsNumAtRisk': 174, 'otherNumAffected': 42, 'seriousNumAtRisk': 174, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}], 'seriousEvents': [{'term': 'Nephrotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate 110 µg QD', 'description': 'Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.11', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-2.01', 'spread': '0.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.604', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.094', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.45', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis method was adjusted for Baseline rTNSS, country, age, and gender, in addition to treatment effect.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to Week 4', 'description': 'The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3 (total score 0-9). The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The rTNSS was a rating of the severity of symptoms over the previous 12 hours and was performed in the morning (AM rTNSS) and evening (post meridian \\[PM\\] rTNSS). The daily rTNSS was the sum of two assessments. The Baseline daily rTNSS was defined as the average of the daily rTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population comprised of all participants who were randomized and received at least one dose of study drug. Only participants present at the specified time point were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Morning (AM) Pre-dose Instantaneous Total Nasal Symptom Scores (iTNSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate 110 µg QD', 'description': 'Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.65', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-1.59', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.729', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.061', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.41', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis method was adjusted for Baseline iTNSS, country, age, and gender, in addition to treatment effect.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to Week 4', 'description': 'The morning pre-dose iTNSS was the sum of the individual symptom score for rhinorrhoea, nasal congestion and postnasal drip performed immediately prior to taking the daily dose which were scored on a scale of 0-3 (total score 0-9). The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The Baseline daily iTNSS was defined as the average of the daily iTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline value.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Only participants available at the specified timepoint were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Based on Overall Evaluation of Response to Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.'}, {'id': 'OG001', 'title': 'Fluticasone Furoate 110 µg QD', 'description': 'Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.'}], 'classes': [{'title': 'Significantly Improved', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Moderately Improved', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Mildly Improved', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Mildly Worse', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Moderately Worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Significantly Worse', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.064', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Overall evaluation of response to therapy was illustrated and analyzed using logistic regression adjusting for age, gender, investigator, and treatmen'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 (Day 29) or Early Withdrawal', 'description': 'Participants were evaluated effectiveness of study medication for relieving non-allergic rhinitis symptoms over the entire treatment period. The overall evaluation of response to therapy was based on a 7-point categorical scale (1-7) where the participants rate their perception of the change or lack of change in their VMR symptoms at the end of the study. The 7 categories were: 1: significantly improved, 2: moderately improved, 3: mildly improved, 4: no change, 5: mildly worse, 6: moderately worse and 7: significantly worse. Effectiveness of study medication for relieving VMR symptoms over the entire treatment period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants available at the specified time point were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants were instructed to self administer two sprays of placebo into each nostril once daily (QD) in the morning (ante meridian \\[AM\\]), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.'}, {'id': 'FG001', 'title': 'Fluticasone Furoate 110 µg QD', 'description': 'Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '174'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}, {'groupId': 'FG001', 'numSubjects': '165'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Participant took two different treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The actual dose delivered from the product was 27.5 micrograms (µg) /actuation, which is therefore proposed as the label claim rather than 25 µg/actuation. Based on this spray content assessment, the dose examined in this study was actually 110 µg rather than the 100 µg dose indicated in the protocol.', 'preAssignmentDetails': 'Males and females \\>=12 years of age, diagnosed with vasomotor rhinitis (VMR) and meeting the symptom requirements entered a 7 to 14 days screening period. Following screening period, participants meeting specified symptom criteria received treatment of either fluticasone furoate or placebo in 1:1 ratio up to 4 weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '347', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.'}, {'id': 'BG001', 'title': 'Fluticasone Furoate 110 µg QD', 'description': 'Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '14.72', 'groupId': 'BG000'}, {'value': '43.8', 'spread': '15.44', 'groupId': 'BG001'}, {'value': '43.9', 'spread': '15.06', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '331', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2006-02-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-14', 'studyFirstSubmitDate': '2005-07-01', 'resultsFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2005-07-01', 'lastUpdatePostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-21', 'studyFirstPostDateStruct': {'date': '2005-07-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS)', 'timeFrame': 'Baseline and up to Week 4', 'description': 'The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3 (total score 0-9). The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The rTNSS was a rating of the severity of symptoms over the previous 12 hours and was performed in the morning (AM rTNSS) and evening (post meridian \\[PM\\] rTNSS). The daily rTNSS was the sum of two assessments. The Baseline daily rTNSS was defined as the average of the daily rTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Morning (AM) Pre-dose Instantaneous Total Nasal Symptom Scores (iTNSS)', 'timeFrame': 'Baseline and up to Week 4', 'description': 'The morning pre-dose iTNSS was the sum of the individual symptom score for rhinorrhoea, nasal congestion and postnasal drip performed immediately prior to taking the daily dose which were scored on a scale of 0-3 (total score 0-9). The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The Baseline daily iTNSS was defined as the average of the daily iTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline value.'}, {'measure': 'Number of Participants Based on Overall Evaluation of Response to Therapy', 'timeFrame': 'Week 4 (Day 29) or Early Withdrawal', 'description': 'Participants were evaluated effectiveness of study medication for relieving non-allergic rhinitis symptoms over the entire treatment period. The overall evaluation of response to therapy was based on a 7-point categorical scale (1-7) where the participants rate their perception of the change or lack of change in their VMR symptoms at the end of the study. The 7 categories were: 1: significantly improved, 2: moderately improved, 3: mildly improved, 4: no change, 5: mildly worse, 6: moderately worse and 7: significantly worse. Effectiveness of study medication for relieving VMR symptoms over the entire treatment period.'}]}, 'conditionsModule': {'keywords': ['nonallergic rhinitis', 'GW685698X', 'VMR', 'vasomotor rhinitis'], 'conditions': ['Vasomotor Rhinitis', 'Rhinitis, Vasomotor']}, 'referencesModule': {'availIpds': [{'id': 'FFR30007', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'FFR30007', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'FFR30007', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'FFR30007', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'FFR30007', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'FFR30007', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'FFR30007', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Must be outpatients.\n* Diagnosis of VMR (vasomotor rhinitis).\n* Literate in English or native language.\n\nExclusion criteria:\n\n* Significant concomitant medical condition.\n* Use corticosteroids or other allergy medications during the study.\n* Used tobacco products within the past year.'}, 'identificationModule': {'nctId': 'NCT00118703', 'briefTitle': 'Once-Daily Investigational Nasal Spray In Adults And Adolescents With Vasomotor Rhinitis', 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