Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-02-25 @ 5:53 PM
Study NCT ID:
NCT00570492
Status:
COMPLETED
Last Update Posted:
2017-09-15
First Post:
2007-12-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Mexico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}, {'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'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'}]}}, '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': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.', 'otherNumAtRisk': 237, 'otherNumAffected': 135, 'seriousNumAtRisk': 237, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'FFNS 110 mcg', 'description': 'Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.', 'otherNumAtRisk': 237, 'otherNumAffected': 129, 'seriousNumAtRisk': 237, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 37}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 34}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory Tract Infection Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia Primary Atypical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory Tract Infection Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Head Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 237, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Growth Velocity of Pre-pubescent Pediatric Participants to the End of the 52-week Double-blind (DB) Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.'}, {'id': 'OG001', 'title': 'FFNS 110 mcg', 'description': 'Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.46', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '5.19', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.270', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '-0.06', 'estimateComment': 'An analysis of covariance (ANCOVA) was performed to estimate the mean treatment difference in growth velocity over the treatment period, adjusting for baseline growth velocity, age, gender, and country.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52)', 'description': 'Height was measured (triplicate measurements) in pre-pubescent pediatric participants via stadiometry at each clinic visit during the entire 76-week study period (16-week Baseline Period, 52-week DB Treatment Period and 8-week Follow-up Period). Growth velocity was calculated by fitting a regression line to all height measurements recorded for the participant during the period and was determined by the slope of the fitted regression line. Change from Baseline was calculated as the value over the 52-week Treatment Period minus the value over the 16-week Baseline Period.', 'unitOfMeasure': 'Centimeters per year (cm/year)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Growth Population: all randomized participants with height assessments via stadiometry from at least three post-randomization clinic visits during the DB Treatment Period'}, {'type': 'SECONDARY', 'title': 'Mean 24-hour Urinary Free Cortisol Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.'}, {'id': 'OG001', 'title': 'FFNS 110 mcg', 'description': 'Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.'}], 'classes': [{'title': 'End of 16-week Baseline Period, n=168, 172', 'categories': [{'measurements': [{'value': '9.771', 'spread': '6.0479', 'groupId': 'OG000'}, {'value': '9.242', 'spread': '5.5821', 'groupId': 'OG001'}]}]}, {'title': 'End of 52-week DB Treatment Period, n=163, 169', 'categories': [{'measurements': [{'value': '11.340', 'spread': '9.6775', 'groupId': 'OG000'}, {'value': '11.125', 'spread': '9.2195', 'groupId': 'OG001'}]}]}, {'title': 'End of 8-week Follow-up Period, n=161, 167', 'categories': [{'measurements': [{'value': '10.615', 'spread': '6.6903', 'groupId': 'OG000'}, {'value': '10.311', 'spread': '5.9986', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Randomization/end of 16-week Baseline Period (Week 0), End of 52-week DB Treatment Period (Week 52), and end of 8-week Follow-up Period (Week 60)', 'description': "Hypothalamic-pitiutary-adrenal (HPA) axis function was assessed by the measurement of urinary free cortisol, using urine samples collected over the course of 24 hours by the parent/guardian in the participants' home on an out-patient basis within 7 days prior to the indicated time points. Detailed verbal instructions and a take-home instruction card on how to conduct the 24-hour urine collection were provided to the parent/guardian before each collection interval.", 'unitOfMeasure': 'Micrograms per 24 hours (mcg/24 hours)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Urine Cortisol Population: all randomized participants excluding those whose urine samples were considered to have confounding factors affecting the interpretation of the 24-hour urinary cortisol results. One participant in each arm had a Baseline value \\<1.0 and was not analyzed. Some participants had samples that were not acceptable for analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.'}, {'id': 'OG001', 'title': 'FFNS 110 mcg', 'description': 'Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.'}], 'classes': [{'title': 'Mucosal Bleeding, Improved', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal Bleeding, No Change', 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal Bleeding, Worsened', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Ulcers, Improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ulcers, No Change', 'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}]}, {'title': 'Ulcers, Worsened', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Polyps, Improved', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Polyps, No Change', 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}]}, {'title': 'Polyps, Worsened', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52)', 'description': 'NE included the evaluation of the size of ulcers/polyps (of nasal turbinates/septa) and assessment for mucosal bleeding (MB) at all study visits. Polyps are non-cancerous growths; ulcers are breaks in the skin/mucous membrane with loss of surface tissue, disintegration, and necrosis of epithelial tissue. For MB, Improved=shift from present (\\>=1 nostril) to absent (both nostrils); Worsened=shift from absent (both nostrils) to present (\\>=1 nostril). For polyps/ulcers, Improved=shift from large to small or from small to none; Worsened=shift from none to small or from small to none (\\>=1 nostril).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who had been randomized to and received at least one dose of double-blind study medication. Most participants received examinations at each visit; however, on some occasions, some assessments were not completed for various reasons.'}, {'type': 'SECONDARY', 'title': 'Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.'}, {'id': 'OG001', 'title': 'FFNS 110 mcg', 'description': 'Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.'}], 'classes': [{'title': 'Alk P, Baseline Period, n=231, 234', 'categories': [{'measurements': [{'value': '246.8', 'spread': '57.45', 'groupId': 'OG000'}, {'value': '249.8', 'spread': '67.81', 'groupId': 'OG001'}]}]}, {'title': 'Alk P, DB Treatment Period, n=184, 182', 'categories': [{'measurements': [{'value': '261.9', 'spread': '61.96', 'groupId': 'OG000'}, {'value': '262.9', 'spread': '71.22', 'groupId': 'OG001'}]}]}, {'title': 'Alk P, Follow-up Period, n=175, 174', 'categories': [{'measurements': [{'value': '264.2', 'spread': '59.67', 'groupId': 'OG000'}, {'value': '264.6', 'spread': '67.44', 'groupId': 'OG001'}]}]}, {'title': 'ALT, Baseline Period, n=231, 234', 'categories': [{'measurements': [{'value': '14.8', 'spread': '4.54', 'groupId': 'OG000'}, {'value': '15.1', 'spread': '4.73', 'groupId': 'OG001'}]}]}, {'title': 'ALT, DB Treatment Period, n=184, 182', 'categories': [{'measurements': [{'value': '15.9', 'spread': '8.50', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '5.12', 'groupId': 'OG001'}]}]}, {'title': 'ALT, Follow-up Period, n=175, 174', 'categories': [{'measurements': [{'value': '16.7', 'spread': '14.41', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '13.15', 'groupId': 'OG001'}]}]}, {'title': 'AST, Baseline Period, n=229, 232', 'categories': [{'measurements': [{'value': '27.4', 'spread': '4.89', 'groupId': 'OG000'}, {'value': '28.1', 'spread': '4.89', 'groupId': 'OG001'}]}]}, {'title': 'AST, DB Treatment Period, n=175, 179', 'categories': [{'measurements': [{'value': '27.0', 'spread': '5.49', 'groupId': 'OG000'}, {'value': '27.6', 'spread': '4.87', 'groupId': 'OG001'}]}]}, {'title': 'AST, Follow-up Period, n=169, 174', 'categories': [{'measurements': [{'value': '27.7', 'spread': '8.93', 'groupId': 'OG000'}, {'value': '28.3', 'spread': '10.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Alk P, ALT, and AST.', 'unitOfMeasure': 'International Units per liter (IU/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Values for the Laboratory Parameters if Albumin and Total Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.'}, {'id': 'OG001', 'title': 'FFNS 110 mcg', 'description': 'Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.'}], 'classes': [{'title': 'Albumin, Baseline Period, n=231, 234', 'categories': [{'measurements': [{'value': '45.8', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '46.0', 'spread': '2.33', 'groupId': 'OG001'}]}]}, {'title': 'Albumin, DB Treatment Period, n=184, 182', 'categories': [{'measurements': [{'value': '45.7', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '45.9', 'spread': '2.25', 'groupId': 'OG001'}]}]}, {'title': 'Albumin, Follow-up Period, n=175, 175', 'categories': [{'measurements': [{'value': '45.8', 'spread': '2.31', 'groupId': 'OG000'}, {'value': '45.6', 'spread': '2.36', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein, Baseline Period, n=231, 234', 'categories': [{'measurements': [{'value': '72.0', 'spread': '3.78', 'groupId': 'OG000'}, {'value': '71.9', 'spread': '4.30', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein, DB Treatment Period, n=184, 182', 'categories': [{'measurements': [{'value': '71.7', 'spread': '3.76', 'groupId': 'OG000'}, {'value': '71.7', 'spread': '3.95', 'groupId': 'OG001'}]}]}, {'title': 'Total Protein, Follow-up Period, n=175, 175', 'categories': [{'measurements': [{'value': '71.5', 'spread': '3.66', 'groupId': 'OG000'}, {'value': '71.5', 'spread': '3.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Albumin and Total Protein.', 'unitOfMeasure': 'Grams per liter (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.'}, {'id': 'OG001', 'title': 'FFNS 110 mcg', 'description': 'Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.'}], 'classes': [{'title': 'Total Bilirubin, Baseline Period, n=231, 234', 'categories': [{'measurements': [{'value': '6.9', 'spread': '2.43', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '3.40', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin, DB Treatment Period, n=184, 182', 'categories': [{'measurements': [{'value': '7.2', 'spread': '2.69', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '3.56', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin, Follow-up Period, n=175, 175', 'categories': [{'measurements': [{'value': '7.0', 'spread': '2.72', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '3.14', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, Baseline Period, n=231, 234', 'categories': [{'measurements': [{'value': '43.3', 'spread': '7.98', 'groupId': 'OG000'}, {'value': '43.6', 'spread': '7.96', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, DB Treatment Period, n=184, 182', 'categories': [{'measurements': [{'value': '45.0', 'spread': '8.34', 'groupId': 'OG000'}, {'value': '44.6', 'spread': '8.16', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine, Follow-up Period, n=175, 175', 'categories': [{'measurements': [{'value': '44.5', 'spread': '7.38', 'groupId': 'OG000'}, {'value': '45.0', 'spread': '7.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Total Bilirubin and Creatinine.', 'unitOfMeasure': 'Micromoles (µmol)/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.'}, {'id': 'OG001', 'title': 'FFNS 110 mcg', 'description': 'Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.'}], 'classes': [{'title': 'Glucose, Baseline Period, n=230, 231', 'categories': [{'measurements': [{'value': '4.83', 'spread': '0.683', 'groupId': 'OG000'}, {'value': '4.86', 'spread': '0.690', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, DB Treatment Period, n=184, 182', 'categories': [{'measurements': [{'value': '4.82', 'spread': '0.782', 'groupId': 'OG000'}, {'value': '4.78', 'spread': '0.720', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, Follow-up Period, n=175, 175', 'categories': [{'measurements': [{'value': '4.87', 'spread': '0.840', 'groupId': 'OG000'}, {'value': '4.85', 'spread': '0.700', 'groupId': 'OG001'}]}]}, {'title': 'Calcium, Baseline Period, n=229, 232', 'categories': [{'measurements': [{'value': '2.441', 'spread': '0.0786', 'groupId': 'OG000'}, {'value': '2.435', 'spread': '0.0993', 'groupId': 'OG001'}]}]}, {'title': 'Calcium, DB Treatment Period, n=175, 179', 'categories': [{'measurements': [{'value': '2.437', 'spread': '0.0776', 'groupId': 'OG000'}, {'value': '2.440', 'spread': '0.0847', 'groupId': 'OG001'}]}]}, {'title': 'Calcium, Follow-up Period, n=169, 173', 'categories': [{'measurements': [{'value': '2.438', 'spread': '0.0769', 'groupId': 'OG000'}, {'value': '2.436', 'spread': '0.0820', 'groupId': 'OG001'}]}]}, {'title': 'Potassium, Baseline Period, n=229, 232', 'categories': [{'measurements': [{'value': '4.30', 'spread': '0.404', 'groupId': 'OG000'}, {'value': '4.31', 'spread': '0.437', 'groupId': 'OG001'}]}]}, {'title': 'Potassium, DB Treatment Period, n=175, 179', 'categories': [{'measurements': [{'value': '4.30', 'spread': '0.373', 'groupId': 'OG000'}, {'value': '4.30', 'spread': '0.345', 'groupId': 'OG001'}]}]}, {'title': 'Potassium, Follow-up Period, n=169, 173', 'categories': [{'measurements': [{'value': '4.28', 'spread': '0.362', 'groupId': 'OG000'}, {'value': '4.32', 'spread': '0.409', 'groupId': 'OG001'}]}]}, {'title': 'Sodium, Baseline Period, n=231, 234', 'categories': [{'measurements': [{'value': '139.4', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '139.3', 'spread': '1.83', 'groupId': 'OG001'}]}]}, {'title': 'Sodium, DB Treatment Period, n=184, 182', 'categories': [{'measurements': [{'value': '139.1', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '139.2', 'spread': '1.58', 'groupId': 'OG001'}]}]}, {'title': 'Sodium, Follow-up Period, n=175, 175', 'categories': [{'measurements': [{'value': '139.3', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '139.4', 'spread': '2.19', 'groupId': 'OG001'}]}]}, {'title': 'Urea/BUN, Baseline Period, n=231, 235', 'categories': [{'measurements': [{'value': '4.99', 'spread': '1.897', 'groupId': 'OG000'}, {'value': '4.77', 'spread': '1.195', 'groupId': 'OG001'}]}]}, {'title': 'Urea/BUN, DB Treatment Period, n=184, 182', 'categories': [{'measurements': [{'value': '4.82', 'spread': '1.315', 'groupId': 'OG000'}, {'value': '4.82', 'spread': '1.294', 'groupId': 'OG001'}]}]}, {'title': 'Urea/BUN, Follow-up Period, n=175, 175', 'categories': [{'measurements': [{'value': '4.93', 'spread': '1.219', 'groupId': 'OG000'}, {'value': '4.75', 'spread': '1.274', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Glucose, Calcium, Potassium, Sodium, and Urea/BUN.', 'unitOfMeasure': 'Millimoles (mmol)/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.'}, {'id': 'OG001', 'title': 'FFNS 110 mcg', 'description': 'Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.'}], 'classes': [{'title': 'Basophil, Baseline Period, n=228, 231', 'categories': [{'measurements': [{'value': '0.026', 'spread': '0.0176', 'groupId': 'OG000'}, {'value': '0.025', 'spread': '0.0151', 'groupId': 'OG001'}]}]}, {'title': 'Basophil, DB Treatment Period, n=186, 188', 'categories': [{'measurements': [{'value': '0.026', 'spread': '0.0198', 'groupId': 'OG000'}, {'value': '0.027', 'spread': '0.0184', 'groupId': 'OG001'}]}]}, {'title': 'Basophil, Follow-up Period, n=177, 179', 'categories': [{'measurements': [{'value': '0.026', 'spread': '0.0172', 'groupId': 'OG000'}, {'value': '0.025', 'spread': '0.0165', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophil, Baseline Period, n=228, 231', 'categories': [{'measurements': [{'value': '0.395', 'spread': '0.3292', 'groupId': 'OG000'}, {'value': '0.455', 'spread': '0.3859', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophil, DB Treatment Period, n=186, 188', 'categories': [{'measurements': [{'value': '0.442', 'spread': '0.3505', 'groupId': 'OG000'}, {'value': '0.394', 'spread': '0.3577', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophil, Follow-up Period, n=177, 179', 'categories': [{'measurements': [{'value': '0.419', 'spread': '0.3337', 'groupId': 'OG000'}, {'value': '0.409', 'spread': '0.3296', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocyte, Baseline Period, n=228, 231', 'categories': [{'measurements': [{'value': '3.046', 'spread': '0.9686', 'groupId': 'OG000'}, {'value': '2.987', 'spread': '0.9158', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocyte, DB Treatment Period, n=177, 179', 'categories': [{'measurements': [{'value': '2.779', 'spread': '0.8038', 'groupId': 'OG000'}, {'value': '2.820', 'spread': '0.8424', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocyte, Follow-up Period, n=169, 173', 'categories': [{'measurements': [{'value': '2.871', 'spread': '0.8784', 'groupId': 'OG000'}, {'value': '2.841', 'spread': '0.8107', 'groupId': 'OG001'}]}]}, {'title': 'WBC, Baseline Period, n=228, 231', 'categories': [{'measurements': [{'value': '7.71', 'spread': '2.077', 'groupId': 'OG000'}, {'value': '7.36', 'spread': '1.818', 'groupId': 'OG001'}]}]}, {'title': 'WBC, DB Treatment Period, n=186, 188', 'categories': [{'measurements': [{'value': '7.14', 'spread': '1.899', 'groupId': 'OG000'}, {'value': '6.98', 'spread': '1.896', 'groupId': 'OG001'}]}]}, {'title': 'WBC, Follow-up Period, n=177, 179', 'categories': [{'measurements': [{'value': '7.18', 'spread': '1.945', 'groupId': 'OG000'}, {'value': '6.96', 'spread': '1.894', 'groupId': 'OG001'}]}]}, {'title': 'Monocyte, Baseline Period, n=228, 231', 'categories': [{'measurements': [{'value': '0.348', 'spread': '0.1655', 'groupId': 'OG000'}, {'value': '0.373', 'spread': '0.1870', 'groupId': 'OG001'}]}]}, {'title': 'Monocyte, DB Treatment Period, n=186, 188', 'categories': [{'measurements': [{'value': '0.320', 'spread': '0.1393', 'groupId': 'OG000'}, {'value': '0.343', 'spread': '0.1598', 'groupId': 'OG001'}]}]}, {'title': 'Monocyte, Follow-up Period, n=177, 179', 'categories': [{'measurements': [{'value': '0.334', 'spread': '0.1471', 'groupId': 'OG000'}, {'value': '0.326', 'spread': '0.1592', 'groupId': 'OG001'}]}]}, {'title': 'Segmented Neu, Baseline Period, n=228, 231', 'categories': [{'measurements': [{'value': '3.892', 'spread': '1.6722', 'groupId': 'OG000'}, {'value': '3.517', 'spread': '1.5347', 'groupId': 'OG001'}]}]}, {'title': 'Segmented Neu, DB Treatment Period, n=186, 188', 'categories': [{'measurements': [{'value': '3.572', 'spread': '1.5407', 'groupId': 'OG000'}, {'value': '3.391', 'spread': '1.4828', 'groupId': 'OG001'}]}]}, {'title': 'Segmented Neu, Follow-up Period, n=177, 179', 'categories': [{'measurements': [{'value': '3.572', 'spread': '1.5623', 'groupId': 'OG000'}, {'value': '3.354', 'spread': '1.4379', 'groupId': 'OG001'}]}]}, {'title': 'Platelet, Baseline Period, n=230, 230', 'categories': [{'measurements': [{'value': '313.8', 'spread': '70.19', 'groupId': 'OG000'}, {'value': '314.1', 'spread': '59.46', 'groupId': 'OG001'}]}]}, {'title': 'Platelet, DB Treatment Period, n=187, 187', 'categories': [{'measurements': [{'value': '278.6', 'spread': '55.58', 'groupId': 'OG000'}, {'value': '279.5', 'spread': '49.51', 'groupId': 'OG001'}]}]}, {'title': 'Platelet, Follow-up Period, n=175, 180', 'categories': [{'measurements': [{'value': '276.4', 'spread': '49.27', 'groupId': 'OG000'}, {'value': '283.6', 'spread': '59.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Participants in the study were evaluated for the following hematology laboratory parameters at the indicated time points: Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet counts.', 'unitOfMeasure': 'Giga (10^9) cells (Gi)/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Values for Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.'}, {'id': 'OG001', 'title': 'FFNS 110 mcg', 'description': 'Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.'}], 'classes': [{'title': 'Baseline Period, n=231, 231', 'categories': [{'measurements': [{'value': '129.5', 'spread': '7.87', 'groupId': 'OG000'}, {'value': '128.4', 'spread': '8.00', 'groupId': 'OG001'}]}]}, {'title': 'DB Treatment Period, n=186, 188', 'categories': [{'measurements': [{'value': '131.8', 'spread': '7.32', 'groupId': 'OG000'}, {'value': '130.8', 'spread': '7.77', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Period, n=177, 180', 'categories': [{'measurements': [{'value': '132.1', 'spread': '7.43', 'groupId': 'OG000'}, {'value': '130.0', 'spread': '7.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Hemoglobin was assessed in participants at the indicated time points.', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Values for Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.'}, {'id': 'OG001', 'title': 'FFNS 110 mcg', 'description': 'Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.'}], 'classes': [{'title': 'Baseline Period, n=231, 231', 'categories': [{'measurements': [{'value': '0.3823', 'spread': '0.02296', 'groupId': 'OG000'}, {'value': '0.3783', 'spread': '0.02480', 'groupId': 'OG001'}]}]}, {'title': 'DB Treatment Period, n=186, 188', 'categories': [{'measurements': [{'value': '0.3904', 'spread': '0.02291', 'groupId': 'OG000'}, {'value': '0.3873', 'spread': '0.02481', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Period, n=177, 180', 'categories': [{'measurements': [{'value': '0.3906', 'spread': '0.02227', 'groupId': 'OG000'}, {'value': '0.3844', 'spread': '0.02416', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Hematocrit was assessed in participants at indicated the time points. Hematocrit is the percentage of blood volume (BV) that is occupied by red blood cells (RBCs).', 'unitOfMeasure': 'Percentage of BV occupied by RBCs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Hematology Values for Red Blood Cells (RBCs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.'}, {'id': 'OG001', 'title': 'FFNS 110 mcg', 'description': 'Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.'}], 'classes': [{'title': 'Baseline Period, n=231, 231', 'categories': [{'measurements': [{'value': '4.59', 'spread': '0.312', 'groupId': 'OG000'}, {'value': '4.54', 'spread': '0.327', 'groupId': 'OG001'}]}]}, {'title': 'DB Treatment Period, n=186, 188', 'categories': [{'measurements': [{'value': '4.56', 'spread': '0.303', 'groupId': 'OG000'}, {'value': '4.53', 'spread': '0.319', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Period, n=177, 180', 'categories': [{'measurements': [{'value': '4.57', 'spread': '0.306', 'groupId': 'OG000'}, {'value': '4.50', 'spread': '0.314', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'RBCs was assessed in participants at the indicated time points.', 'unitOfMeasure': 'Trillion (10^12) cells (Ti)/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Values for Urine pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.'}, {'id': 'OG001', 'title': 'FFNS 110 mcg', 'description': 'Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.'}], 'classes': [{'title': 'Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '6.02', 'spread': '0.477', 'groupId': 'OG000'}, {'value': '6.00', 'spread': '0.536', 'groupId': 'OG001'}]}]}, {'title': 'DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '6.02', 'spread': '0.547', 'groupId': 'OG000'}, {'value': '6.05', 'spread': '0.507', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '6.05', 'spread': '0.538', 'groupId': 'OG000'}, {'value': '6.05', 'spread': '0.524', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Values for Urine Specific Gravity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.'}, {'id': 'OG001', 'title': 'FFNS 110 mcg', 'description': 'Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.'}], 'classes': [{'title': 'Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '1.0240', 'spread': '0.00718', 'groupId': 'OG000'}, {'value': '1.0234', 'spread': '0.00673', 'groupId': 'OG001'}]}]}, {'title': 'DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '1.0244', 'spread': '0.00695', 'groupId': 'OG000'}, {'value': '1.0234', 'spread': '0.00649', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '1.0237', 'spread': '0.00642', 'groupId': 'OG000'}, {'value': '1.0242', 'spread': '0.00672', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.'}, {'id': 'OG001', 'title': 'FFNS 110 mcg', 'description': 'Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.'}], 'classes': [{'title': 'UB-Neg, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '233', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}]}, {'title': 'UB-Pos, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'UB-Neg, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}]}, {'title': 'UB-Pos, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'UB-Neg, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}]}, {'title': 'UB-Pos, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urine Nitrite-Neg, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}]}, {'title': 'Urine Nitrite-Pos, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urine Nitrite-Neg, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '178', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}]}, {'title': 'Urine Nitrite-Pos, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Urine Nitrite-Neg, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '179', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}]}, {'title': 'Urine Nitrite-Pos, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Bilirubin is a normal body by-product (bile), and nitrite is a by-product of bacterial growth. Participants were categorized as Negative (Neg.) or Positive (Pos.) based on the absence or presence, respectively, of urine bilirubin (UB) and urine nitrate.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.'}, {'id': 'OG001', 'title': 'FFNS 110 mcg', 'description': 'Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.'}], 'classes': [{'title': 'Urine Glucose-Neg, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '233', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}]}, {'title': 'Urine Glucose-Neg, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}]}, {'title': 'Urine Glucose-Tr, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urine Glucose-Neg, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '179', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}]}, {'title': 'Urine Glucose-1+, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urine Ketones-Neg, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}]}, {'title': 'Urine Ketones-Trace, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urine Ketones-1+, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urine Ketones-Neg, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '179', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}]}, {'title': 'Urine Ketones-Tr, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Urine Ketones-Neg, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}]}, {'title': 'Urine Ketones-Trace, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urine Ketones-1+, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urine Protein-Neg, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '218', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}]}, {'title': 'Urine Protein-Trace, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Urine Protein-1+, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Urine Protein-2+, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urine Protein-Neg, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}]}, {'title': 'Urine Protein-Tr, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Urine Protein-1+, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Urine Protein-2+, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Urine Protein-3+, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urine Protein-Neg, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}]}, {'title': 'Urine Protein-Trace, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Urine Protein-1+, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Urine Ketones-2+, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urine Ketones-3+, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Urine glucose, urine ketones, and urine proteins were measured in participants using a dipstick (qualitative) test at the indicated time points. In this dipstick test, the level of glucose, ketones, and protein in urine samples was recorded as negative (Neg), trace (tr), 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Participants were categorized as negative or positive based on the absence or presence, respectively, of glucose, ketones, and proteins in the urine.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.'}, {'id': 'OG001', 'title': 'FFNS 110 mcg', 'description': 'Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.'}], 'classes': [{'title': 'Urine OB-Neg, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '226', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}]}, {'title': 'Urine OB-Small, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urine OB-Moderate, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urine OB-Trace, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Urine OB-1+, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urine OB-Neg, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '178', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}]}, {'title': 'Urine OB-Trace, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urine OB-1+, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urine OB-3+, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urine OB-Neg, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}]}, {'title': 'Urine OB-Trace, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urine OB-1+, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urine OB-2+, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urine LET-Neg, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '220', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}]}, {'title': 'Urine LET-Small, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Urine LET-Moderate, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urine LET-Large, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urine LET-Trace, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urine LET-1+, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Urine LET-2+, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Urine LET-3+, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Urine LET-Neg, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}]}, {'title': 'Urine LET-Trace, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Urine LET-1+, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Urine LET-2+, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Urine LET-3+, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urine LET-Neg, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '162', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}]}, {'title': 'Urine LET-Trace, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Urine LET-1+, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Urine LET-2+, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Urine LET-3+, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Occult blood (OB) is blood that cannot be seen without a microscope. Normal urine does not contain any red blood cells. Leukocyte esterase is an enzyme and is not found in normal urine. In the dipstick (qualitative) test, the level of OB and leukocyte esterase in urine samples was recorded as negative (Neg), small, moderate, large, trace, 1+ (slightly positive), 2+ (positive), and 3+ (high positive). Participants were categorized as negative or positive based on the absence or presence, respectively, of OB and urine leukocyte esterase.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.'}, {'id': 'OG001', 'title': 'FFNS 110 mcg', 'description': 'Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.'}], 'classes': [{'title': 'Urine App.-Clear, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}]}, {'title': 'Urine App.-Cloudy, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Urine App.-Turbid, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Urine App.-Clear, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}]}, {'title': 'Urine App.-Cloudy, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Urine App.-Turbid, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Urine App.-Clear, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}]}, {'title': 'Urine App.-Cloudy, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Urine App.-Turbid, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Urine Color-Straw, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Urine Color-Yellow, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}]}, {'title': 'Urine Color-DY, Baseline Period, n=233, 229', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Urine Color-Straw, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Urine Color-Yellow, DB Treatment Period, n=182,181', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}]}, {'title': 'Urine Color-DY, DB Treatment Period, n=182, 181', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Urine Color-Straw, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Urine Color-Yellow, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}]}, {'title': 'Urine Color-DY, Follow-up Period, n=180, 186', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Participants were assessed for their urine appearance, which was categorized as clear (normal), cloudy (presence of crystals, blood cells, or bacteria), of turbid. Also, participants were categorized by the color of urine: straw, yellow (normal urine), and dark yellow (DY) (which may be the result of bile in the urine).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo: Baseline Period', 'description': 'Placebo nasal spray administered once daily (OD) as 2 sprays per nostril to all enrolled participants during the 16-week Single-blind Baseline period, to assess the baseline growth velocity'}, {'id': 'FG001', 'title': 'Placebo: Double-blind Treatment Period', 'description': 'Participants were randomized to receive matching placebo nasal spray OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period'}, {'id': 'FG002', 'title': 'FFNS 110 mcg: Double-blind Treatment Period', 'description': 'Participants were randomized to receive fluticasone furoate nasal spray (FFNS) 110 micrograms (mcg) OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period'}], 'periods': [{'title': '16-week Single-blind Baseline Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '910'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '474'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '436'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': "Didn't Meet Inclusion/Exclusion Criteria", 'reasons': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': "Didn't Meet Randomization Criteria", 'reasons': [{'groupId': 'FG000', 'numSubjects': '263'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': "Randomized but Did'nt Receive Treatment", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': '52-week Double-blind Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '237'}, {'groupId': 'FG002', 'numSubjects': '237'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '187'}, {'groupId': 'FG002', 'numSubjects': '186'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '51'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Reached Protocol-defined Stop Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'After screening and a 16-week Baseline Period (Pd.), participants (par.) were randomized 1:1 to each treatment arm during the 52-week Treatment Pd. After the Treatment Pd., par. entered an 8-week Follow-up (FU) Pd. during which all par. received placebo nasal spray. Par. completing at least 12 weeks of treatment were to complete the FU Pd.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'BG000'}, {'value': '237', 'groupId': 'BG001'}, {'value': '474', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.'}, {'id': 'BG001', 'title': 'FFNS 110 mcg', 'description': 'Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.61', 'spread': '0.969', 'groupId': 'BG000'}, {'value': '6.64', 'spread': '0.933', 'groupId': 'BG001'}, {'value': '6.63', 'spread': '0.950', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline characteristics were collected for the Intent-to-Treat (ITT) Population, which included all participants who had been randomized to and received at least one dose of Double-blind study medication.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '326', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Baseline characteristics were collected for the Intent-to-Treat (ITT) Population, which included all participants who had been randomized to and received at least one dose of Double-blind study medication.', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American (Amc)/African Heritage', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Amc Indian or Alaska Native (Alk N)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '189', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}]}]}, {'title': 'African Amc/African and Amc Indian or Alk N', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'African Amc/African Heritage and White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Amc Indian or Alk N and White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian and White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian/ Other Pacific Islander and White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Baseline characteristics were collected for the Intent-to-Treat (ITT) Population, which included all participants who had been randomized to and received at least one dose of Double-blind study medication.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 474}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11-26'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2011-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-17', 'studyFirstSubmitDate': '2007-12-06', 'resultsFirstSubmitDate': '2011-11-03', 'studyFirstSubmitQcDate': '2007-12-10', 'lastUpdatePostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-01-05', 'studyFirstPostDateStruct': {'date': '2007-12-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Growth Velocity of Pre-pubescent Pediatric Participants to the End of the 52-week Double-blind (DB) Treatment Period', 'timeFrame': 'Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52)', 'description': 'Height was measured (triplicate measurements) in pre-pubescent pediatric participants via stadiometry at each clinic visit during the entire 76-week study period (16-week Baseline Period, 52-week DB Treatment Period and 8-week Follow-up Period). Growth velocity was calculated by fitting a regression line to all height measurements recorded for the participant during the period and was determined by the slope of the fitted regression line. Change from Baseline was calculated as the value over the 52-week Treatment Period minus the value over the 16-week Baseline Period.'}], 'secondaryOutcomes': [{'measure': 'Mean 24-hour Urinary Free Cortisol Excretion', 'timeFrame': 'Randomization/end of 16-week Baseline Period (Week 0), End of 52-week DB Treatment Period (Week 52), and end of 8-week Follow-up Period (Week 60)', 'description': "Hypothalamic-pitiutary-adrenal (HPA) axis function was assessed by the measurement of urinary free cortisol, using urine samples collected over the course of 24 hours by the parent/guardian in the participants' home on an out-patient basis within 7 days prior to the indicated time points. Detailed verbal instructions and a take-home instruction card on how to conduct the 24-hour urine collection were provided to the parent/guardian before each collection interval."}, {'measure': 'Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results', 'timeFrame': 'Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52)', 'description': 'NE included the evaluation of the size of ulcers/polyps (of nasal turbinates/septa) and assessment for mucosal bleeding (MB) at all study visits. Polyps are non-cancerous growths; ulcers are breaks in the skin/mucous membrane with loss of surface tissue, disintegration, and necrosis of epithelial tissue. For MB, Improved=shift from present (\\>=1 nostril) to absent (both nostrils); Worsened=shift from absent (both nostrils) to present (\\>=1 nostril). For polyps/ulcers, Improved=shift from large to small or from small to none; Worsened=shift from none to small or from small to none (\\>=1 nostril).'}, {'measure': 'Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Alk P, ALT, and AST.'}, {'measure': 'Mean Values for the Laboratory Parameters if Albumin and Total Protein', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Albumin and Total Protein.'}, {'measure': 'Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Total Bilirubin and Creatinine.'}, {'measure': 'Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Glucose, Calcium, Potassium, Sodium, and Urea/BUN.'}, {'measure': 'Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Participants in the study were evaluated for the following hematology laboratory parameters at the indicated time points: Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet counts.'}, {'measure': 'Mean Values for Hemoglobin', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Hemoglobin was assessed in participants at the indicated time points.'}, {'measure': 'Mean Values for Hematocrit', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Hematocrit was assessed in participants at indicated the time points. Hematocrit is the percentage of blood volume (BV) that is occupied by red blood cells (RBCs).'}, {'measure': 'Mean Hematology Values for Red Blood Cells (RBCs)', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'RBCs was assessed in participants at the indicated time points.'}, {'measure': 'Mean Values for Urine pH', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).'}, {'measure': 'Mean Values for Urine Specific Gravity', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.'}, {'measure': 'Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Bilirubin is a normal body by-product (bile), and nitrite is a by-product of bacterial growth. Participants were categorized as Negative (Neg.) or Positive (Pos.) based on the absence or presence, respectively, of urine bilirubin (UB) and urine nitrate.'}, {'measure': 'Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Urine glucose, urine ketones, and urine proteins were measured in participants using a dipstick (qualitative) test at the indicated time points. In this dipstick test, the level of glucose, ketones, and protein in urine samples was recorded as negative (Neg), trace (tr), 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Participants were categorized as negative or positive based on the absence or presence, respectively, of glucose, ketones, and proteins in the urine.'}, {'measure': 'Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Occult blood (OB) is blood that cannot be seen without a microscope. Normal urine does not contain any red blood cells. Leukocyte esterase is an enzyme and is not found in normal urine. In the dipstick (qualitative) test, the level of OB and leukocyte esterase in urine samples was recorded as negative (Neg), small, moderate, large, trace, 1+ (slightly positive), 2+ (positive), and 3+ (high positive). Participants were categorized as negative or positive based on the absence or presence, respectively, of OB and urine leukocyte esterase.'}, {'measure': 'Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color', 'timeFrame': 'Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)', 'description': 'Participants were assessed for their urine appearance, which was categorized as clear (normal), cloudy (presence of crystals, blood cells, or bacteria), of turbid. Also, participants were categorized by the color of urine: straw, yellow (normal urine), and dark yellow (DY) (which may be the result of bile in the urine).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['allergic rhinitis', 'fluticasone furoate nasal spray', 'growth'], 'conditions': ['Rhinitis, Allergic, Perennial']}, 'referencesModule': {'availIpds': [{'id': 'FFR101782', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'FFR101782', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'FFR101782', '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': 'FFR101782', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'FFR101782', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'FFR101782', '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': 'FFR101782', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '25017530', 'type': 'DERIVED', 'citation': 'Lee LA, Sterling R, Maspero J, Clements D, Ellsworth A, Pedersen S. Growth velocity reduced with once-daily fluticasone furoate nasal spray in prepubescent children with perennial allergic rhinitis. J Allergy Clin Immunol Pract. 2014 Jul-Aug;2(4):421-7. doi: 10.1016/j.jaip.2014.04.008. Epub 2014 May 21.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to characterize, as accurately as possible, the estimation of the difference in pre-pubescent growth velocities between subjects treated continuously for one year with FFNS 110mcg QD, the highest dose approved for pediatric use in the US, and placebo nasal spray as determined by stadiometry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Signed and dated informed consent obtained from the subject's legal parent/guardian. Adequate provisions for assent of children should be provided in accordance with the IRB and any local governance.\n* Age: 5 to less than 7.5 years for females and 5 to less than 8.5 years for males at Visit 1.\n* Subjects must have a diagnosis and history of perennial allergic rhinitis (PAR) as follows:\n* At least a one year clinical history and treatment of PAR (written or verbal confirmation from the treating physician) and,\n* A documented, positive skin test to an appropriate perennial allergen (animal dander, house dust mites, cockroaches and/or mold) or documented, historical, in vitro test results for a specific IgE (such as RAST, PRIST) within the past 12 months prior to Visit 1 will be allowed. A positive skin test during Visit 1 will also be allowed. A positive skin test is defined as a wheal 3mm larger than the diluent control for prick testing.\n\nNote: Subjects who meet the above criteria and who may also have seasonal allergic rhinitis (SAR) and/or non-allergic rhinitis (NAR) are eligible for randomization.\n\n* At Visit 2, the daily rTNSS on any 4 of the last 7 days prior to Visit 2 must be 5. Subjects should refrain from using rescue medication during the 7 days prior to Visit 2.\n* Pre-pubescence: Tanner Staging equal to 1 for all classifications as assessed by the investigator during each of the five baseline study visits (Visit 1 through Visit 5). The same investigator should perform this assessment throughout the study for a respective subject, if possible, for consistency of assessment. Details are provided in the SPM.\n* Current height measurement via standardized stadiometer is within the 3rd and 97th percentile according to the CDC and any local longitudinal standard height charts for age and gender as provided in the SPM (Visit 1 through Visit 5).\n* Body weight and body mass index between the 3rd and 97th percentile according to the US CDC standards and any local standards as assessed during each of the five baseline study visits (Visit 1 through Visit 5). The US CDC standards are provided in the SPM.\n* Compliance: Subject's parent/guardian is literate and both subject and parent/guardian are deemed capable of complying with all study procedures to include proper study drug administration, daily e-diary completion, in-clinic laboratory assessments, and in-home 24 hour urine collection during the 76 weeks of study participation (Visit 1 through Visit 5).\n\nExclusion criteria:\n\n* A history or evidence of abnormal growth. Any previous or current condition that affects growth, including sleep disorders.\n* Asthma, with the exception of mild intermittent asthma \\[National Asthma Education and Prevention Program, 2007\\] (Note: Subjects will be allowed to use short-acting inhaled beta2 agonists only on an as needed basis.)\n* A history of nasal or sinus surgery, septal perforation, or severe obstruction in the nose (e.g. nasal polyps).\n* Any other significant concomitant medical condition. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or which would confound the interpretation of the study results if the disease/condition exacerbated during the study. (Visit 1 through Visit 5)\n* Any prior or current use of any medication/treatment that might affect growth including, but not limited to, methylphenidate hydrochloride, thyroid hormone, growth hormone, anabolic steroids, calcitonin, estrogens, progestins, biphosphonates, anticonvulsants or phosphate binding antacids. (Visit 1 through Visit 5).\n* Use of corticosteroids, defined as:\n* Inhaled, intranasal, or high potency topical (to include dermatological, optic and otic) corticosteroids within 6 weeks prior to Visit 1 or during the baseline period (Visit 1 through Visit 5).\n* Systemic corticosteroids (to include oral and injectable) within 12 weeks prior to Visit 1 or during the baseline period (Visit 1 through Visit 5).\n* Use of other allergy medications within an appropriate timeframe relative to Visit 1 to allow the medication to be eliminated or no longer producing an effect as well as during the baseline period (Visit 1 through Visit 5) including, but not limited to:\n* Intranasal cromolyn - 14 days\n* Short-acting prescription and OTC antihistamines - 3 days\n* Long acting (second-generation) antihistamines (other than the loratadine syrup supplied by GSK to treat uncontrolled symptoms of PAR) including fexofenadine, cetirizine, desloratadine, and astemizole - 10 days\n* Long-acting antihistamine: astemizole - 12 weeks\n* Intranasal antihistamines (e.g. azelastine) -2 weeks\n* Oral or intranasal decongestants - 3 days\n* Intranasal, oral or inhaled anticholinergics - 3 days\n* Oral antileukotrienes - 3 days\n* Subcutaneous omalizumab - 5 months\n* Immunotherapy initiated or adjusted within 30 days prior to Visit 1 or during the baseline period (Visit 1 through Visit 5) noting that no significant changes in the dose, concentration or dilution will be allowed during the study.\n* Use of immunosuppressive medications 8 weeks prior to screening or during the baseline period (Visit 1 through Visit 5) of the study.\n* Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole. (Visit 1 through Visit 5)\n* Allergy/Intolerance\n* Known hypersensitivity to corticosteroids or any excipients in the nasal spray\n* Known hypersensitivity to the antihistamine or decongestant being provided for worsening symptoms of rhinitis during the conduct of the study.\n* Exposure to varicella (Chickenpox) or measles during the 3 weeks prior to screening or during the baseline period (Visit 1 through Visit 5), if non-immune. A diagnosis of varicella or measles during the baseline period is exclusionary as well.\n* Recent exposure to an investigational study drug within 30 days prior toVisit 1.\n* Affiliation with investigational site.\n* Findings of a clinically significant, abnormal screening (Visit 1) clinical laboratory test."}, 'identificationModule': {'nctId': 'NCT00570492', 'briefTitle': 'Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study.', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Effects of a One-Year Course of Fluticasone Furoate Nasal Spray 110mcg QD on Growth in Pre-Pubescent, Pediatric Subjects With Perennial Allergic Rhinitis', 'orgStudyIdInfo': {'id': 'FFR101782'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo nasal spray', 'interventionNames': ['Drug: Placebo nasal 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