Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-03-02 @ 8:40 PM
Study NCT ID:
NCT01630135
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2012-06-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study FFR116364, a Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C523187', 'term': 'fluticasone furoate'}]}}, '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': 'Participants were analyzed from the start of study treatment until the follow up contact (up to 3 weeks).', 'description': 'Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication, according to the actual treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'Fluticasone Furoate 55 µg Per Day', 'description': 'Fluticasone furoate nasal spray (55 micrograms \\[µg\\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.', 'otherNumAtRisk': 131, 'otherNumAffected': 23, 'seriousNumAtRisk': 131, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.', 'otherNumAtRisk': 130, 'otherNumAffected': 25, 'seriousNumAtRisk': 130, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Conjunctivitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Hand-foot-and-mouth disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Pneumonia mycoplasmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Streptococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Heat illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Eosinophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Orthostatic intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Heat rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 15.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Furoate 55 µg Per Day', 'description': 'Fluticasone furoate nasal spray (55 micrograms \\[µg\\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.98', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.89', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.089', 'ciLowerLimit': '-1.41', 'ciUpperLimit': '-0.76', 'estimateComment': 'The analysis was based on an analysis of covariance (ANCOVA) with a model adjusting for Treatment, Baseline, Age, and Sex.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through the entire treatment period (2 weeks)', 'description': "The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score for the entire treatment period minus the score at Baseline.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): all participants meeting the primary criteria for enrollment, without any major good clinical practice (GCP) deviation, who received at least one dose of the assigned treatment and had diary assessment for 3TNSS after receiving a dose of study medication'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in 3TNSS at Week 1 and Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Furoate 55 µg Per Day', 'description': 'Fluticasone furoate nasal spray (55 micrograms \\[µg\\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.'}], 'classes': [{'title': 'Week 1, n=131, 130', 'categories': [{'measurements': [{'value': '-1.60', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, n=131, 128', 'categories': [{'measurements': [{'value': '-2.38', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-1.10', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 1 and Week 2', 'description': "The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For Week 1 and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score at Week 1 and Week 2 minus the score at Baseline.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Change from Baseline was analyzed for only those participants who were available for assessment at both Baseline and the indicated assessment period. The analysis was based on ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Furoate 55 µg Per Day', 'description': 'Fluticasone furoate nasal spray (55 micrograms \\[µg\\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.'}], 'classes': [{'title': 'Entire treatment period, n=131, 130', 'categories': [{'measurements': [{'value': '-39.76', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '-17.74', 'spread': '2.36', 'groupId': 'OG001'}]}]}, {'title': 'Week 1, n=131, 130', 'categories': [{'measurements': [{'value': '-31.96', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '-13.89', 'spread': '2.44', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, n=131, 128', 'categories': [{'measurements': [{'value': '-47.89', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '-21.95', 'spread': '2.70', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through the entire treatment period (2 weeks), Week 1, and Week 2', 'description': "The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value \\* 100.", 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in 3TNSS at the Indicated Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Furoate 55 µg Per Day', 'description': 'Fluticasone furoate nasal spray (55 micrograms \\[µg\\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.'}], 'classes': [{'title': 'Day 1, n=130, 130', 'categories': [{'measurements': [{'value': '-0.71', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.52', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 2, n=131, 130', 'categories': [{'measurements': [{'value': '-1.33', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Day 3, n=131, 130', 'categories': [{'measurements': [{'value': '-1.53', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-0.61', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Day 4, n=131, 130', 'categories': [{'measurements': [{'value': '-1.69', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Day 5, n=131, 130', 'categories': [{'measurements': [{'value': '-1.89', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Day 6, n=131, 130', 'categories': [{'measurements': [{'value': '-1.95', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-0.97', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, n=131, 130', 'categories': [{'measurements': [{'value': '-2.05', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-0.87', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Day 8, n=131, 128', 'categories': [{'measurements': [{'value': '-2.14', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-1.05', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Day 9, n=131, 128', 'categories': [{'measurements': [{'value': '-2.29', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-1.07', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Day 10, n=131, 128', 'categories': [{'measurements': [{'value': '-2.32', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-1.01', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Day 11, n=131, 128', 'categories': [{'measurements': [{'value': '-2.36', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-1.19', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Day 12, n=131, 128', 'categories': [{'measurements': [{'value': '-2.54', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.21', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Day 13, n=122, 123', 'categories': [{'measurements': [{'value': '-2.47', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, n=105, 115', 'categories': [{'measurements': [{'value': '-2.65', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-0.93', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Days 1 through 14', 'description': "The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). Change from Baseline was calculated as the mean score at the indicated day minus the score at Baseline.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Change from Baseline was analyzed for only those participants who were available for assessment at both Baseline and the indicated study day (Days 1 through 14). The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Furoate 55 µg Per Day', 'description': 'Fluticasone furoate nasal spray (55 micrograms \\[µg\\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.'}], 'classes': [{'title': 'Entire Treatment Period, n=131, 130', 'categories': [{'measurements': [{'value': '-2.40', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.01', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Week 1, n=131, 130', 'categories': [{'measurements': [{'value': '-1.94', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, n= 131, 128', 'categories': [{'measurements': [{'value': '-2.89', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-1.29', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through the entire treatment period (2 weeks), Week 1, and Week 2', 'description': "The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the 4TNSS in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Furoate 55 µg Per Day', 'description': 'Fluticasone furoate nasal spray (55 micrograms \\[µg\\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.'}], 'classes': [{'title': 'Entire Treatment Period, n=131, 130', 'categories': [{'measurements': [{'value': '-40.42', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '-16.09', 'spread': '2.44', 'groupId': 'OG001'}]}]}, {'title': 'Week 1, n=131, 130', 'categories': [{'measurements': [{'value': '-32.55', 'spread': '2.54', 'groupId': 'OG000'}, {'value': '-11.54', 'spread': '2.52', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, n= 131, 128', 'categories': [{'measurements': [{'value': '-48.58', 'spread': '2.78', 'groupId': 'OG000'}, {'value': '-20.92', 'spread': '2.78', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through the entire treatment period (2 weeks), Week 1, and Week 2', 'description': "The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 4TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value \\* 100.", 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Furoate 55 µg Per Day', 'description': 'Fluticasone furoate nasal spray (55 micrograms \\[µg\\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.'}], 'classes': [{'title': 'Rhinorrhea, ETP, n=131, 130', 'categories': [{'measurements': [{'value': '-0.69', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Rhinorrhea, Week 1, n=131, 130', 'categories': [{'measurements': [{'value': '-0.55', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Rhinorrhea, Week 2, n=131, 128', 'categories': [{'measurements': [{'value': '-0.85', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Nasal congestion, ETP, n=131, 130', 'categories': [{'measurements': [{'value': '-0.70', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Nasal congestion, Week 1, n=131, 130', 'categories': [{'measurements': [{'value': '-0.56', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Nasal congestion, Week 2, n=131, 128', 'categories': [{'measurements': [{'value': '-0.84', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Sneezing, ETP, n=131, 130', 'categories': [{'measurements': [{'value': '-0.60', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Sneezing, Week 1, n=131, 130', 'categories': [{'measurements': [{'value': '-0.50', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Sneezing, Week 2, n= 131, 128', 'categories': [{'measurements': [{'value': '-0.71', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Nasal itching, ETP, n=131, 130', 'categories': [{'measurements': [{'value': '-0.41', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Nasal itching, Week 1, n=131, 130', 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Nasal itching, Week 2, n= 131, 128', 'categories': [{'measurements': [{'value': '-0.49', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through the entire treatment period (2 weeks), Week 1, and Week 2', 'description': "Four individual symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching) were scored on a scale from 0 to 3 using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the symptom scores in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Furoate 55 µg Per Day', 'description': 'Fluticasone furoate nasal spray (55 micrograms \\[µg\\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.'}], 'classes': [{'title': 'Entire Treatment Period, n=131, 130', 'categories': [{'measurements': [{'value': '-0.46', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.32', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Week 1, n=131, 130', 'categories': [{'measurements': [{'value': '-0.31', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, n= 131, 128', 'categories': [{'measurements': [{'value': '-0.61', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through the entire treatment period (2 weeks), Week 1, and Week 2', 'description': "Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Furoate 55 µg Per Day', 'description': 'Fluticasone furoate nasal spray (55 micrograms \\[µg\\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.'}], 'classes': [{'title': 'Entire Treatment Period, n=99, 92', 'categories': [{'measurements': [{'value': '-0.77', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 1, n=99, 92', 'categories': [{'measurements': [{'value': '-0.56', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, n= 99, 90', 'categories': [{'measurements': [{'value': '-0.99', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through the entire treatment period (2 weeks), Week 1, and Week 2', 'description': "Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Only those participants with BL TOSS \\>0 who were available for assessment at both BL and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. Analysis was based on an ANCOVA with a model adjusting for Treatment, BL, Age, and Sex.'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Furoate 55 µg Per Day', 'description': 'Fluticasone furoate nasal spray (55 micrograms \\[µg\\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.'}], 'classes': [{'title': 'Entire Treatment Period, n=99, 92', 'categories': [{'measurements': [{'value': '-20.97', 'spread': '11.39', 'groupId': 'OG000'}, {'value': '1.57', 'spread': '11.64', 'groupId': 'OG001'}]}]}, {'title': 'Week 1, n=99, 92', 'categories': [{'measurements': [{'value': '-9.20', 'spread': '10.90', 'groupId': 'OG000'}, {'value': '5.37', 'spread': '11.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, n= 99, 90', 'categories': [{'measurements': [{'value': '-33.52', 'spread': '13.27', 'groupId': 'OG000'}, {'value': '-1.70', 'spread': '13.69', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through the entire treatment period (2 weeks), Week 1, and Week 2', 'description': "Symptoms of eye itching, tearing, and redness were scored by the participant's (par.) parent/guardian who signed the ICF or the par. themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the par.'s diary. The TOSS is the sum of all 3 symptom scores and ranges from 0 to 9. The mean of the BL period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each par. was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from BL=(mean score at post-BL assessment minus score at BL) divided by the BL value \\* 100. Par. with a BL TOSS of 0 were not analyzed because percent change from BL could not be calculated.", 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline (BL) in the TOSS for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Furoate 55 µg Per Day', 'description': 'Fluticasone furoate nasal spray (55 micrograms \\[µg\\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.'}], 'classes': [{'title': 'Entire Treatment Period, n=99, 92', 'categories': [{'measurements': [{'value': '-20.97', 'spread': '11.39', 'groupId': 'OG000'}, {'value': '1.57', 'spread': '11.64', 'groupId': 'OG001'}]}]}, {'title': 'Week 1, n=99, 92', 'categories': [{'measurements': [{'value': '-9.20', 'spread': '10.90', 'groupId': 'OG000'}, {'value': '5.37', 'spread': '11.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, n=99, 90', 'categories': [{'measurements': [{'value': '-33.52', 'spread': '13.27', 'groupId': 'OG000'}, {'value': '-1.70', 'spread': '13.69', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through the entire treatment period (2 weeks), Week 1, and Week 2', 'description': "Symptoms of eye itching, tearing, and redness were scored by the participant's (par.) parent/guardian who signed the ICF or the par. themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the par.'s diary. The TOSS is the sum of all 3 symptom scores and ranges from 0 to 9. The mean of the BL period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each par. was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from BL=(mean score at post-BL assessment minus score at BL) divided by the BL value \\* 100.", 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Only those participants with BL TOSS \\>0 who were available for assessment at both BL and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. Analysis was based on an ANCOVA with a model adjusting for Treatment, BL, Age, and Sex.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Furoate 55 µg Per Day', 'description': 'Fluticasone furoate nasal spray (55 micrograms \\[µg\\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.'}], 'classes': [{'title': 'Eye itching, Entire Treatment Period, n=131, 130', 'categories': [{'measurements': [{'value': '-0.24', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Eye itching, Week 1, n=131, 130', 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Eye itching Week 2, n=131, 128', 'categories': [{'measurements': [{'value': '-0.34', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Tearing, Entire Treatment Period, n=131, 130', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'Tearing, Week 1, n=131, 130', 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'Tearing, Week 2, n=131, 128', 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'Redness, Entire Treatment Period, n=131, 130', 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'Redness, Week 1, n=131, 130', 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'Redness, Week 2, n=130, 128', 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through the entire treatment period (2 weeks), Week 1, and Week 2', 'description': "Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, at Week 1, and at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Furoate 55 µg Per Day', 'description': 'Fluticasone furoate nasal spray (55 micrograms \\[µg\\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.'}], 'classes': [{'title': 'Entire Treatment Period, n=131, 130', 'categories': [{'measurements': [{'value': '-0.43', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Week 1, n=131, 130', 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, n=131, 128', 'categories': [{'measurements': [{'value': '-0.53', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through the entire treatment period (2 weeks), Week 1, and Week 2', 'description': "The participant's parent/guardian who signed the ICF or the participant themself scored the participant's troubles with daily life once daily using the following scale: 0, None; 1, Few troubles; 2, Intermediate between 3 and 1; or 3, Painful and complicating daily life. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Furoate 55 µg Per Day', 'description': 'Fluticasone furoate nasal spray (55 micrograms \\[µg\\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.'}], 'classes': [{'title': 'SOITM, Baseline, Score 0, n=131, 130', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'SOITM, Baseline, Score 1, n=131, 130', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'SOITM, Baseline, Score 2, n=131, 130', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'SOITM, Baseline, Score 3, n=131, 130', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'SOITM, Week 1, Score 0, n=131, 128', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'SOITM, Week 1, Score 1, n=131, 128', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'SOITM, Week 1, Score 2, n=131, 128', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'SOITM, Week 1, Score 3, n=131, 128', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'SOITM, Week 2/EW, Score 0, n=131, 130', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'SOITM, Week 2/EW, Score 1, n=131, 130', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'SOITM, Week 2/EW, Score 2, n=131, 130', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'SOITM, Week 2/EW, Score 3, n=131, 130', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'COITM, Baseline, Score 0, n=131, 130', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'COITM, Baseline, Score 1, n=131, 130', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'COITM, Baseline, Score 2, n=131, 130', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'COITM, Baseline, Score 3, n=131, 130', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'COITM, Week 1, Score 0, n= 131, 128', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'COITM, Week 1, Score 1, n= 131, 128', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'COITM, Week 1, Score 2, n= 131, 128', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'COITM, Week 1, Score 3, n= 131, 128', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'COITM, Week 2/EW, Score 0, n=131, 130', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'COITM, Week 2/EW, Score 1, n=131, 130', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'COITM, Week 2/EW, Score 2, n=131, 130', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'COITM, Week 2/EW, Score 3, n=131, 130', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'QTND, Baseline, Score 0, n=131, 130', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'QTND, Baseline, Score 1, n=131, 130', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'QTND, Baseline, Score 2, n=131, 130', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'QTND, Baseline, Score 3, n=131, 130', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'QTND, Week 1, Score 0, n= 131, 128', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'QTND, Week 1, Score 1, n= 131, 128', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'QTND, Week 1, Score 2, n= 131, 128', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'QTND, Week 1, Score 3, n= 131, 128', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'QTND, Week 2/EW, Score 0, n=131, 130', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'QTND, Week 2/EW, Score 1, n=131, 130', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'QTND, Week 2/EW, Score 2, n=131, 130', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'QTND, Week 2/EW, Score 3, n=131, 130', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'QLND, Baseline, Score 0, n=131, 130', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'QLND, Baseline, Score 1, n=131, 130', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QLND, Baseline, Score 2, n=131, 130', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'QLND, Baseline, Score 3, n=131, 130', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'QLND, Week 1, Score 0, n= 131, 128', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'QLND, Week 1, Score 1, n= 131, 128', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'QLND, Week 1, Score 2, n= 131, 128', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'QLND, Week 1, Score 3, n= 131, 128', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'QLND, Week 2/EW, Score 0, n=131, 130', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'QLND, Week 2/EW, Score 1, n=131, 130', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'QLND, Week 2/EW, Score 2, n=131, 130', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'QLND, Week 2/EW, Score 3, n=131, 130', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 1, and Week 2/Early Withdrawal (EW)', 'description': 'Rhinoscopy was assessed by the investigator by scoring swelling of inferior turbinate mucosa (SOITM) scored as 0 (none), 1 (possible to see center of the middle turbinate), 2 (between 3 and 1), or 3 (impossible to see middle turbinate); color of inferior turbinate mucosa (COITM) scored as 0 (normal), 1 (pink), 2 (red), or 3 (pale); quantity of nasal discharge (QTND) scored as 0 (none), 1 (small amount adhered), 2 (between 3 and 1), or 3 (filled); and quality of nasal discharge (QLND) scored as 0 (none), 1 (pyoid), 2 (viscous), or 3 (watery).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Participants who were withdrawn before Visit 3 (Week 1) were not included in the analysis for Week 1.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Furoate 55 µg Per Day', 'description': 'Fluticasone furoate nasal spray (55 micrograms \\[µg\\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.'}], 'classes': [{'title': 'Significantly improved', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Moderately improved', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Mildly improved', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Mildly worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Moderately worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Significantly worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2/EW', 'description': "The investigator evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': "Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant", 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Furoate 55 µg Per Day', 'description': 'Fluticasone furoate nasal spray (55 micrograms \\[µg\\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.'}], 'classes': [{'title': 'Significantly improved', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Moderately improved', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Mildly improved', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Mildly worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Moderately worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Significantly worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2/EW', 'description': "The participant's parent/guardian who signed the ICF or the participant themself evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fluticasone Furoate 55 µg Per Day', 'description': 'Fluticasone furoate nasal spray (55 micrograms \\[µg\\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '130'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '128'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol-defined Stopping Criteria Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '261', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fluticasone Furoate 55 µg Per Day', 'description': 'Fluticasone furoate nasal spray (55 micrograms \\[µg\\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'spread': '2.32', 'groupId': 'BG000'}, {'value': '10.1', 'spread': '2.22', 'groupId': 'BG001'}, {'value': '10.1', 'spread': '2.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian - Japanese Heritage', 'categories': [{'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '261', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 261}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-20', 'studyFirstSubmitDate': '2012-06-26', 'resultsFirstSubmitDate': '2013-03-14', 'studyFirstSubmitQcDate': '2012-06-26', 'lastUpdatePostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-14', 'studyFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period', 'timeFrame': 'Baseline through the entire treatment period (2 weeks)', 'description': "The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score for the entire treatment period minus the score at Baseline."}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in 3TNSS at Week 1 and Week 2', 'timeFrame': 'Baseline; Week 1 and Week 2', 'description': "The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For Week 1 and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score at Week 1 and Week 2 minus the score at Baseline."}, {'measure': 'Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2', 'timeFrame': 'Baseline through the entire treatment period (2 weeks), Week 1, and Week 2', 'description': "The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value \\* 100."}, {'measure': 'Mean Change From Baseline in 3TNSS at the Indicated Days', 'timeFrame': 'Baseline; Days 1 through 14', 'description': "The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). Change from Baseline was calculated as the mean score at the indicated day minus the score at Baseline."}, {'measure': 'Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2', 'timeFrame': 'Baseline through the entire treatment period (2 weeks), Week 1, and Week 2', 'description': "The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the 4TNSS in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value."}, {'measure': 'Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2', 'timeFrame': 'Baseline through the entire treatment period (2 weeks), Week 1, and Week 2', 'description': "The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 4TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value \\* 100."}, {'measure': 'Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2', 'timeFrame': 'Baseline through the entire treatment period (2 weeks), Week 1, and Week 2', 'description': "Four individual symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching) were scored on a scale from 0 to 3 using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the symptom scores in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value."}, {'measure': 'Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2', 'timeFrame': 'Baseline through the entire treatment period (2 weeks), Week 1, and Week 2', 'description': "Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value."}, {'measure': 'Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2', 'timeFrame': 'Baseline through the entire treatment period (2 weeks), Week 1, and Week 2', 'description': "Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value."}, {'measure': 'Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2', 'timeFrame': 'Baseline through the entire treatment period (2 weeks), Week 1, and Week 2', 'description': "Symptoms of eye itching, tearing, and redness were scored by the participant's (par.) parent/guardian who signed the ICF or the par. themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the par.'s diary. The TOSS is the sum of all 3 symptom scores and ranges from 0 to 9. The mean of the BL period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each par. was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from BL=(mean score at post-BL assessment minus score at BL) divided by the BL value \\* 100. Par. with a BL TOSS of 0 were not analyzed because percent change from BL could not be calculated."}, {'measure': 'Mean Percent Change From Baseline (BL) in the TOSS for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2', 'timeFrame': 'Baseline through the entire treatment period (2 weeks), Week 1, and Week 2', 'description': "Symptoms of eye itching, tearing, and redness were scored by the participant's (par.) parent/guardian who signed the ICF or the par. themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the par.'s diary. The TOSS is the sum of all 3 symptom scores and ranges from 0 to 9. The mean of the BL period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each par. was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from BL=(mean score at post-BL assessment minus score at BL) divided by the BL value \\* 100."}, {'measure': 'Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2', 'timeFrame': 'Baseline through the entire treatment period (2 weeks), Week 1, and Week 2', 'description': "Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value."}, {'measure': 'Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, at Week 1, and at Week 2', 'timeFrame': 'Baseline through the entire treatment period (2 weeks), Week 1, and Week 2', 'description': "The participant's parent/guardian who signed the ICF or the participant themself scored the participant's troubles with daily life once daily using the following scale: 0, None; 1, Few troubles; 2, Intermediate between 3 and 1; or 3, Painful and complicating daily life. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value."}, {'measure': 'Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW', 'timeFrame': 'Baseline, Week 1, and Week 2/Early Withdrawal (EW)', 'description': 'Rhinoscopy was assessed by the investigator by scoring swelling of inferior turbinate mucosa (SOITM) scored as 0 (none), 1 (possible to see center of the middle turbinate), 2 (between 3 and 1), or 3 (impossible to see middle turbinate); color of inferior turbinate mucosa (COITM) scored as 0 (normal), 1 (pink), 2 (red), or 3 (pale); quantity of nasal discharge (QTND) scored as 0 (none), 1 (small amount adhered), 2 (between 3 and 1), or 3 (filled); and quality of nasal discharge (QLND) scored as 0 (none), 1 (pyoid), 2 (viscous), or 3 (watery).'}, {'measure': 'Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator', 'timeFrame': 'Week 2/EW', 'description': "The investigator evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse."}, {'measure': "Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant", 'timeFrame': 'Week 2/EW', 'description': "The participant's parent/guardian who signed the ICF or the participant themself evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse."}]}, 'conditionsModule': {'conditions': ['Rhinitis, Allergic, Perennial']}, 'referencesModule': {'availIpds': [{'id': '116364', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '116364', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '116364', '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': '116364', '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'}], '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': 'Efficacy and safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 2 weeks in Japanese paediatric subjects ages 6 to \\< 15 years with perennial allergic rhinitis will be evaluated compared with placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed Consent\n* 6 to \\<15 years of age, male or eligible female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control), outpatient\n* Diagnosis of perennial allergic rhinitis: A positive test response to house dust and/or dust mites on serum antigen-specific IgE antibody test at Visit 1. One year or more clinical history of perennial allergic rhinitis. A positive test result on nasal eosinophil count at Visit 1/1A.\n* Either subject's parent/guardian who signed ICF or subject is able to complete assessments on the patient diary through the study.\n* ALT \\< 2xULN; alkaline phosphatase and bilirubin \\<= 1.5xULN\n* Average of 3TNSS is \\>= 4.0 in the last consecutive 4 days prior to Visit 2.\n* Completion of the patient diary on \\>= 3 days of the last consecutive 4 days prior to Visit 2\n\nExclusion Criteria:\n\n* Has a seasonal pollen as an allergen\n* A nose disorder that could affect the assessment of the study medication or eye or nose surgery (within 3 months prior to Visit 1)\n* Bacterial or viral infection of upper respiratory tract or eye\n* Concurrent disease/abnormalities: Clinically significant uncontrolled disease\n* Known hypersensitivity to corticosteroids or any excipients in the investigational product\n* Has recent participation in a study and/or exposure to an investigational study drug within 3 months prior to Visit 1\n* Use of the following medication and/or its combination drug within the specified time:\n\nAnti-IgE (Within 6 months prior to Visit 1), Immunosuppressive medications or Systemic corticosteroids (Within 8 weeks prior to Visit 1), Topical corticosteroids (Within 4 weeks prior to Visit 1), Immunotherapy or nonspecific allassotherapy which was initiated, discontinued or changed its dose within 4 weeks prior to Visit 1\n\n* Affiliation with Investigator's Site: Relative or employee\n* History of alcohol or drug abuse, children in care or in the opinion of the investigator (sub-investigator), inappropriate to be enrolled in the study.\n* Average of 3TNSS is \\>= 8.0 in the last consecutive 4 days prior to Visit 2.\n* Bacterial or viral infection of upper respiratory tract or eye during the screening period."}, 'identificationModule': {'nctId': 'NCT01630135', 'briefTitle': 'Study FFR116364, a Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Study FFR116364, a Double-blind, Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis', 'orgStudyIdInfo': {'id': '116364'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GW685698X', 'description': 'GW685698X 55mcg/day', 'interventionNames': ['Drug: Fluticasone furoate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Fluticasone furoate', 'type': 'DRUG', 'description': '55 mcg/day, intranasal, 2 weeks', 'armGroupLabels': ['GW685698X']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, intranasal, 2 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '261-0004', 'city': 'Chiba', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '270-0034', 'city': 'Chiba', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '272-0143', 'city': 'Chiba', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '277-0882', 'city': 'Chiba', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '279-0012', 'city': 'Chiba', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '501-3247', 'city': 'Gifu', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'zip': '001-0923', 'city': 'Hokkaido', 'country': 'Japan', 'facility': 'GSK Investigational Site'}, {'zip': '061-1133', 'city': 'Hokkaido', 'country': 'Japan', 'facility': 'GSK Investigational Site'}, {'zip': '062-0034', 'city': 'Hokkaido', 'country': 'Japan', 'facility': 'GSK Investigational Site'}, {'zip': '222-0011', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '222-0031', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '232-0056', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '333-0861', 'city': 'Saitama', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '350-1205', 'city': 'Saitama', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '354-0018', 'city': 'Saitama', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '355-0062', 'city': 'Saitama', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '114-0023', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '125-0052', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '151-0072', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '160-0017', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '170-0005', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '178-0064', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}