Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-18 @ 11:01 AM
Study NCT ID:
NCT02019758
Status:
COMPLETED
Last Update Posted:
2020-04-27
First Post:
2013-12-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057765', 'term': 'Eosinophilic Esophagitis'}], 'ancestors': [{'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019819', 'term': 'Budesonide'}, {'id': 'D000068298', 'term': 'Fluticasone'}, {'id': 'C026285', 'term': 'trichlorosucrose'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'edellon@med.unc.edu', 'phone': '919-966-2513', 'title': 'Evan S. Dellon, MD MPH', 'organization': 'University of North Carolina at Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 weeks over the initial treatment period.', 'eventGroups': [{'id': 'EG000', 'title': 'Oral Viscous Budesonide (OVB)', 'description': 'Subjects will be treated with OVB at a dose of 1 mg twice daily, and they will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with instructions to swallow 4 puffs twice daily.\n\nOral Viscous Budesonide: Oral Viscous Budesonide - 1mg/4 mL, 4 mL of slurry twice daily\n\nPlacebo inhaler: Placebo inhaler - 4 puffs twice daily', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 10, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Active Fluticasone MDI', 'description': 'Subjects will be treated with fluticasone MDI at a dose of 880 mcg twice daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4 mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the OVB.\n\nFluticasone MDI: Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily)\n\nPlacebo slurry: Slurry of sucralose - 4 mL twice daily', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 15, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'esophageal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Food impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post-Treatment Maximum Eosinophil Count (Aim 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Viscous Budesonide (OVB)', 'description': 'Subjects will be treated with OVB at a dose of 1 mg twice daily, and they will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with instructions to swallow 4 puffs twice daily.\n\nOral Viscous Budesonide: Oral Viscous Budesonide - 1mg/4 mL, 4 mL of slurry twice daily\n\nPlacebo inhaler: Placebo inhaler - 4 puffs twice daily'}, {'id': 'OG001', 'title': 'Active Fluticasone MDI', 'description': 'Subjects will be treated with fluticasone MDI at a dose of 880 mcg twice daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4 mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the OVB.\n\nFluticasone MDI: Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily)\n\nPlacebo slurry: Slurry of sucralose - 4 mL twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'spread': '29.0', 'groupId': 'OG000'}, {'value': '20.9', 'spread': '34.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.31', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The mean post-treatment maximum eosinophil count will be compared between the OVB and MDI groups using a two-sample t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'To determine whether viscous budesonide is more effective than fluticasone MDI for improving post-treatment maximum esophageal eosinophil counts (measured in eosinophils per high powered field (eos/hpf)) in patients with eosinophilic esophagitis (EoE). The mean post-treatment maximum eosinophil count will be compared between the OVB and MDI groups using a two-sample t-test.', 'unitOfMeasure': 'eosinophils per high-power field', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Post-treatment Dysphagia Score (Aim 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Viscous Budesonide (OVB)', 'description': 'Subjects will be treated with OVB at a dose of 1 mg twice daily, and they will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with instructions to swallow 4 puffs twice daily.\n\nOral Viscous Budesonide: Oral Viscous Budesonide - 1mg/4 mL, 4 mL of slurry twice daily\n\nPlacebo inhaler: Placebo inhaler - 4 puffs twice daily'}, {'id': 'OG001', 'title': 'Active Fluticasone MDI', 'description': 'Subjects will be treated with fluticasone MDI at a dose of 880 mcg twice daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4 mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the OVB.\n\nFluticasone MDI: Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily)\n\nPlacebo slurry: Slurry of sucralose - 4 mL twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '7.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.70', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The mean DSQ scores will be compared between the OVB and MDI groups using a two-sample t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'To determine whether viscous budesonide is more effective than fluticasone MDI for improving dysphagia (measured by the Daily Symptoms Questionnaire (DSQ)) in patients with EoE. The mean DSQ scores will be compared between the OVB and MDI groups using a two-sample t-test. The DSQ is a dysphagia severity score which ranges from 0-84, with higher numbers indicating more severe symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-treatment Endoscopic Severity (Aim 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Viscous Budesonide (OVB)', 'description': 'Subjects will be treated with OVB at a dose of 1 mg twice daily, and they will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with instructions to swallow 4 puffs twice daily.\n\nOral Viscous Budesonide: Oral Viscous Budesonide - 1mg/4 mL, 4 mL of slurry twice daily\n\nPlacebo inhaler: Placebo inhaler - 4 puffs twice daily'}, {'id': 'OG001', 'title': 'Active Fluticasone MDI', 'description': 'Subjects will be treated with fluticasone MDI at a dose of 880 mcg twice daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4 mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the OVB.\n\nFluticasone MDI: Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily)\n\nPlacebo slurry: Slurry of sucralose - 4 mL twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Endoscopic severity will be quantified using the EoE Endoscopic Reference Score (EREFS) and compared between the two treatment arms. EREFS is a validated endoscopic severity score of key EoE endoscopic features (exudates, rings, edema, furrows, and strictures), and ranges from 0-9 with higher scores indicating higher endoscopic severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Histologic Response of <15 Eos/Hpf', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Viscous Budesonide (OVB)', 'description': 'Subjects will be treated with OVB at a dose of 1 mg twice daily, and they will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with instructions to swallow 4 puffs twice daily.\n\nOral Viscous Budesonide: Oral Viscous Budesonide - 1mg/4 mL, 4 mL of slurry twice daily\n\nPlacebo inhaler: Placebo inhaler - 4 puffs twice daily'}, {'id': 'OG001', 'title': 'Active Fluticasone MDI', 'description': 'Subjects will be treated with fluticasone MDI at a dose of 880 mcg twice daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4 mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the OVB.\n\nFluticasone MDI: Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily)\n\nPlacebo slurry: Slurry of sucralose - 4 mL twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Percentage with histologic response, with response defined as \\<15 eos/hpf, will be compared between groups', 'unitOfMeasure': 'Percent responders', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-treatment Symptom Severity (Aim 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Viscous Budesonide (OVB)', 'description': 'Subjects will be treated with OVB at a dose of 1 mg twice daily, and they will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with instructions to swallow 4 puffs twice daily.\n\nOral Viscous Budesonide: Oral Viscous Budesonide - 1mg/4 mL, 4 mL of slurry twice daily\n\nPlacebo inhaler: Placebo inhaler - 4 puffs twice daily'}, {'id': 'OG001', 'title': 'Active Fluticasone MDI', 'description': 'Subjects will be treated with fluticasone MDI at a dose of 880 mcg twice daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4 mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the OVB.\n\nFluticasone MDI: Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily)\n\nPlacebo slurry: Slurry of sucralose - 4 mL twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '22.1', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '28.0', 'spread': '20.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Post-treatment symptoms severity will be assessed with the EoE Symptom Activity Index (EEsAI), a validated dysphagia severity measure. The EEsAI ranges from 0-100, with higher scores indicating more severe symptoms; symptom remission is defined by a score \\<20.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-treatment Medication Compliance (Aim 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Viscous Budesonide (OVB)', 'description': 'Subjects will be treated with OVB at a dose of 1 mg twice daily, and they will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with instructions to swallow 4 puffs twice daily.\n\nOral Viscous Budesonide: Oral Viscous Budesonide - 1mg/4 mL, 4 mL of slurry twice daily\n\nPlacebo inhaler: Placebo inhaler - 4 puffs twice daily'}, {'id': 'OG001', 'title': 'Active Fluticasone MDI', 'description': 'Subjects will be treated with fluticasone MDI at a dose of 880 mcg twice daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4 mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the OVB.\n\nFluticasone MDI: Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily)\n\nPlacebo slurry: Slurry of sucralose - 4 mL twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Medication compliance as measured by the percentage of medication appropriately used in each arm. For the slurry, this percentage is calculated after measuring the residual volume. For the inhaler, this percentage is calculated after measured using the residual weight.', 'unitOfMeasure': 'Percentage of medication used', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Number of Days Until Symptom Recurrence (Aim 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Viscous Budesonide (OVB)', 'description': 'Subjects will be treated with OVB at a dose of 1 mg twice daily, and they will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with instructions to swallow 4 puffs twice daily.\n\nOral Viscous Budesonide: Oral Viscous Budesonide - 1mg/4 mL, 4 mL of slurry twice daily\n\nPlacebo inhaler: Placebo inhaler - 4 puffs twice daily'}, {'id': 'OG001', 'title': 'Active Fluticasone MDI', 'description': 'Subjects will be treated with fluticasone MDI at a dose of 880 mcg twice daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4 mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the OVB.\n\nFluticasone MDI: Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily)\n\nPlacebo slurry: Slurry of sucralose - 4 mL twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '263', 'spread': '42.0', 'groupId': 'OG000'}, {'value': '224', 'spread': '66.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.52', 'ciUpperLimit': '2.08', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Symptom recurrence or 1 year after completing the initial 8 week treatment', 'description': 'To test whether OVB results in less symptomatic recurrence than fluticasone MDI, the median number of days until symptom occurrence will be quantified between treatment end (week 8) and recurrent symptoms or study end (week 60) as the time of interest. Hazard ratio will be calculated using Cox proportional modeling.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This population reflects only those patients who achieved histologic remission (\\<15 eosinophils per high-power field) after the blinded phase, entered the observation phase, and had symptom outcome data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Histologic Recurrence, Defined as ≥15 Eosinophils Per High-power Field, at Follow-up Endoscopy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Viscous Budesonide (OVB)', 'description': 'Subjects will be treated with OVB at a dose of 1 mg twice daily, and they will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with instructions to swallow 4 puffs twice daily.\n\nOral Viscous Budesonide: Oral Viscous Budesonide - 1mg/4 mL, 4 mL of slurry twice daily\n\nPlacebo inhaler: Placebo inhaler - 4 puffs twice daily'}, {'id': 'OG001', 'title': 'Active Fluticasone MDI', 'description': 'Subjects will be treated with fluticasone MDI at a dose of 880 mcg twice daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4 mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the OVB.\n\nFluticasone MDI: Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily)\n\nPlacebo slurry: Slurry of sucralose - 4 mL twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Symptom recurrence or 1 year after completing the initial 8 week treatment', 'description': 'To test whether OVB results in less histologic recurrence than fluticasone MDI, the number of subjects with ≥15 eosinophils per high-power field at follow-up endoscopy in each group will be compared using chi-square.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This population reflects only those patients who achieved histologic remission (\\<15 eosinophils per high-power field) after the blinded phase, entered the observation phase, and had endoscopic and histologic data available.'}, {'type': 'SECONDARY', 'title': 'Mean Endoscopic Severity Score at Recurrence (Aim 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Viscous Budesonide (OVB)', 'description': 'Subjects will be treated with OVB at a dose of 1 mg twice daily, and they will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with instructions to swallow 4 puffs twice daily.\n\nOral Viscous Budesonide: Oral Viscous Budesonide - 1mg/4 mL, 4 mL of slurry twice daily\n\nPlacebo inhaler: Placebo inhaler - 4 puffs twice daily'}, {'id': 'OG001', 'title': 'Active Fluticasone MDI', 'description': 'Subjects will be treated with fluticasone MDI at a dose of 880 mcg twice daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4 mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the OVB.\n\nFluticasone MDI: Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily)\n\nPlacebo slurry: Slurry of sucralose - 4 mL twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Symptom recurrence or 1 year after completing the initial 8 week treatment', 'description': 'Measurement of endoscopic severity, using the EoE Endoscopic Reference Score (EREFS) measure, at the time of recurrence. EREFS is a validated endoscopic severity score of key EoE endoscopic features (exudates, rings, edema, furrows, and strictures), and ranges from 0-9 with higher scores indicating higher endoscopic severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This population reflects only those patients who achieved histologic remission (\\<15 eosinophils per high-power field) after the blinded phase, entered the observation phase, and had endoscopic and histologic outcome data.'}, {'type': 'SECONDARY', 'title': 'Mean Peak Eosinophil Count (Aim 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Viscous Budesonide (OVB)', 'description': 'Subjects will be treated with OVB at a dose of 1 mg twice daily, and they will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with instructions to swallow 4 puffs twice daily.\n\nOral Viscous Budesonide: Oral Viscous Budesonide - 1mg/4 mL, 4 mL of slurry twice daily\n\nPlacebo inhaler: Placebo inhaler - 4 puffs twice daily'}, {'id': 'OG001', 'title': 'Active Fluticasone MDI', 'description': 'Subjects will be treated with fluticasone MDI at a dose of 880 mcg twice daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4 mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the OVB.\n\nFluticasone MDI: Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily)\n\nPlacebo slurry: Slurry of sucralose - 4 mL twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '71.8', 'spread': '52.9', 'groupId': 'OG000'}, {'value': '35.0', 'spread': '29.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Symptom recurrence or 1 year after completing the initial 8 week treatment', 'description': 'This will assess the mean peak level of esophageal eosinophilia on biopsy (measured in peak eosinophil count - eos/hpf) at the time of recurrence', 'unitOfMeasure': 'eosinophils per high-power field', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This population reflects only those patients who achieved histologic remission (\\<15 eosinophils per high-power field) after the blinded phase, entered the observation phase, and had endoscopic and histologic outcome data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Viscous Budesonide (OVB)', 'description': 'Subjects will be treated with Oral Viscous Budesonide (OVB) at a dose of 1 mg twice daily, and they will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with instructions to swallow 4 puffs twice daily.\n\nOral Viscous Budesonide: Oral Viscous Budesonide - 1mg/4 mL, 4 mL of slurry twice daily\n\nPlacebo inhaler: Placebo inhaler - 4 puffs twice daily'}, {'id': 'FG001', 'title': 'Active Fluticasone Metered Dose Inhaler (MDI)', 'description': 'Subjects will be treated with fluticasone Metered Dose Inhaler (MDI) at a dose of 880 mcg twice daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4 mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the OVB.\n\nFluticasone MDI: Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily)\n\nPlacebo slurry: Slurry of sucralose - 4 mL twice daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '64 received intervention; 1 did not receive intervention', 'groupId': 'FG000', 'numSubjects': '65'}, {'comment': '63 received intervention; 1 did not receive intervention', 'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'Received Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'Did Not Receive Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'achievements': [{'comment': '8 were lost to follow-up and did not undergo week 8 endoscopy or other outcome assessments', 'groupId': 'FG000', 'numSubjects': '8'}, {'comment': '8 were lost to follow-up and did not undergo week 8 endoscopy or other outcome assessments', 'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'comment': '8 were lost to follow-up and did not undergo week 8 endoscopy or other outcome assessments', 'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oral Viscous Budesonide (OVB)', 'description': 'Subjects will be treated with OVB at a dose of 1 mg twice daily, and they will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with instructions to swallow 4 puffs twice daily.\n\nOral Viscous Budesonide: Oral Viscous Budesonide - 1mg/4 mL, 4 mL of slurry twice daily\n\nPlacebo inhaler: Placebo inhaler - 4 puffs twice daily'}, {'id': 'BG001', 'title': 'Active Fluticasone MDI', 'description': 'Subjects will be treated with fluticasone MDI at a dose of 880 mcg twice daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4 mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the OVB.\n\nFluticasone MDI: Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily)\n\nPlacebo slurry: Slurry of sucralose - 4 mL twice daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.2', 'spread': '19.1', 'groupId': 'BG000'}, {'value': '39.0', 'spread': '14.5', 'groupId': 'BG001'}, {'value': '38.6', 'spread': '14.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-14', 'size': 1453497, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-03T08:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-15', 'studyFirstSubmitDate': '2013-12-18', 'resultsFirstSubmitDate': '2019-04-03', 'studyFirstSubmitQcDate': '2013-12-18', 'lastUpdatePostDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-03', 'studyFirstPostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-Treatment Maximum Eosinophil Count (Aim 1)', 'timeFrame': '8 weeks', 'description': 'To determine whether viscous budesonide is more effective than fluticasone MDI for improving post-treatment maximum esophageal eosinophil counts (measured in eosinophils per high powered field (eos/hpf)) in patients with eosinophilic esophagitis (EoE). The mean post-treatment maximum eosinophil count will be compared between the OVB and MDI groups using a two-sample t-test.'}, {'measure': 'Post-treatment Dysphagia Score (Aim 1)', 'timeFrame': '8 weeks', 'description': 'To determine whether viscous budesonide is more effective than fluticasone MDI for improving dysphagia (measured by the Daily Symptoms Questionnaire (DSQ)) in patients with EoE. The mean DSQ scores will be compared between the OVB and MDI groups using a two-sample t-test. The DSQ is a dysphagia severity score which ranges from 0-84, with higher numbers indicating more severe symptoms.'}], 'secondaryOutcomes': [{'measure': 'Post-treatment Endoscopic Severity (Aim 1)', 'timeFrame': '8 weeks', 'description': 'Endoscopic severity will be quantified using the EoE Endoscopic Reference Score (EREFS) and compared between the two treatment arms. EREFS is a validated endoscopic severity score of key EoE endoscopic features (exudates, rings, edema, furrows, and strictures), and ranges from 0-9 with higher scores indicating higher endoscopic severity.'}, {'measure': 'Percentage of Participants With Histologic Response of <15 Eos/Hpf', 'timeFrame': '8 weeks', 'description': 'Percentage with histologic response, with response defined as \\<15 eos/hpf, will be compared between groups'}, {'measure': 'Post-treatment Symptom Severity (Aim 1)', 'timeFrame': '8 weeks', 'description': 'Post-treatment symptoms severity will be assessed with the EoE Symptom Activity Index (EEsAI), a validated dysphagia severity measure. The EEsAI ranges from 0-100, with higher scores indicating more severe symptoms; symptom remission is defined by a score \\<20.'}, {'measure': 'Post-treatment Medication Compliance (Aim 1)', 'timeFrame': '8 weeks', 'description': 'Medication compliance as measured by the percentage of medication appropriately used in each arm. For the slurry, this percentage is calculated after measuring the residual volume. For the inhaler, this percentage is calculated after measured using the residual weight.'}, {'measure': 'Median Number of Days Until Symptom Recurrence (Aim 2)', 'timeFrame': 'Symptom recurrence or 1 year after completing the initial 8 week treatment', 'description': 'To test whether OVB results in less symptomatic recurrence than fluticasone MDI, the median number of days until symptom occurrence will be quantified between treatment end (week 8) and recurrent symptoms or study end (week 60) as the time of interest. Hazard ratio will be calculated using Cox proportional modeling.'}, {'measure': 'Number of Subjects With Histologic Recurrence, Defined as ≥15 Eosinophils Per High-power Field, at Follow-up Endoscopy.', 'timeFrame': 'Symptom recurrence or 1 year after completing the initial 8 week treatment', 'description': 'To test whether OVB results in less histologic recurrence than fluticasone MDI, the number of subjects with ≥15 eosinophils per high-power field at follow-up endoscopy in each group will be compared using chi-square.'}, {'measure': 'Mean Endoscopic Severity Score at Recurrence (Aim 2)', 'timeFrame': 'Symptom recurrence or 1 year after completing the initial 8 week treatment', 'description': 'Measurement of endoscopic severity, using the EoE Endoscopic Reference Score (EREFS) measure, at the time of recurrence. EREFS is a validated endoscopic severity score of key EoE endoscopic features (exudates, rings, edema, furrows, and strictures), and ranges from 0-9 with higher scores indicating higher endoscopic severity.'}, {'measure': 'Mean Peak Eosinophil Count (Aim 2)', 'timeFrame': 'Symptom recurrence or 1 year after completing the initial 8 week treatment', 'description': 'This will assess the mean peak level of esophageal eosinophilia on biopsy (measured in peak eosinophil count - eos/hpf) at the time of recurrence'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eosinophilic Esophagitis']}, 'referencesModule': {'references': [{'pmid': '33009060', 'type': 'DERIVED', 'citation': 'Safroneeva E, Cotton CC, Schoepfer AM, Zwahlen M, Woosley JT, Dellon ES. Dilation Modifies Association Between Symptoms and Esophageal Eosinophilia in Adult Patients With Eosinophilic Esophagitis. Am J Gastroenterol. 2020 Dec;115(12):2098-2102. doi: 10.14309/ajg.0000000000000957.'}, {'pmid': '31499249', 'type': 'DERIVED', 'citation': 'Dellon ES, Woosley JT, Arrington A, McGee SJ, Covington J, Moist SE, Gebhart JH, Galanko JA, Baron JA, Shaheen NJ. Rapid Recurrence of Eosinophilic Esophagitis Activity After Successful Treatment in the Observation Phase of a Randomized, Double-Blind, Double-Dummy Trial. Clin Gastroenterol Hepatol. 2020 Jun;18(7):1483-1492.e2. doi: 10.1016/j.cgh.2019.08.050. Epub 2019 Sep 6.'}, {'pmid': '30872104', 'type': 'DERIVED', 'citation': 'Dellon ES, Woosley JT, Arrington A, McGee SJ, Covington J, Moist SE, Gebhart JH, Tylicki AE, Shoyoye SO, Martin CF, Galanko JA, Baron JA, Shaheen NJ. Efficacy of Budesonide vs Fluticasone for Initial Treatment of Eosinophilic Esophagitis in a Randomized Controlled Trial. Gastroenterology. 2019 Jul;157(1):65-73.e5. doi: 10.1053/j.gastro.2019.03.014. Epub 2019 Mar 11.'}]}, 'descriptionModule': {'briefSummary': 'Purpose: To determine whether oral viscous budesonide (OVB) or fluticasone metered dose inhaler (MDI) most effectively treats EoE by improving histologic findings and symptoms, which medication provides a more durable treatment response, and whether biomarkers can predict treatment response.\n\nParticipants: A total of up to 200 16-80 year old patients with a new diagnosis of eosinophilic esophagitis (EoE) who are referred for upper endoscopy will be consented with a target of 122 randomized.\n\nProcedures: This will be a prospective, randomized, double-blind, double-dummy, clinical trial comparing OVB to fluticasone MDI for treatment of EoE. This overall study design will generate data for all three Aims', 'detailedDescription': 'This will be a prospective, randomized, double-blind, double-dummy, clinical trial comparing oral viscous budesonide (OVB) to fluticasone metered dose inhaler (MDI) for treatment of EoE. A total of 122 subjects aged 16-80 years old will be randomized in a 1:1 fashion to one of two active treatment arms: OVB + placebo inhaler or fluticasone MDI + placebo slurry.\n\nIn the first arm, subjects will be treated with OVB at a dose of 1 mg twice daily, and they will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with instructions to swallow 4 puffs twice daily. The OVB is a slurry equivalent to what is used clinically: 1 mg/4 mL aqueous budesonide mixed with 10 g of sucralose. Rather than asking the subjects to mix the slurry on their own and risk inconsistent formulations, the University of North Carolina (UNC) investigational drug pharmacy (IDP) will provide pre-mixed OVB to all patients. The IDP will also provide placebo inhalers to all patients. The dose for OVB has been chosen because it is the most commonly studied dose, including one prior study led by this Principal Investigator, so we can accurately estimate response rates.\n\nIn the second arm, subjects will be treated with fluticasone MDI at a dose of 880 mcg twice daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4 mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the OVB. The UNC investigational drug pharmacy (IDP) will provide the fluticasone MDIs and pre-mixed placebo slurries to all patients. The dose for fluticasone MDI has been chosen because this is the most commonly used dose in adolescents and adults with EoE, so effect estimates are also available.\n\nFor both arms, the slurry will be administered first, the MDI will be administered 15 minutes later, and patients will take nothing by mouth for an additional 30 minutes.\n\nSubjects will receive 8 weeks of treatment and will then be monitored for up to 52 weeks for recurrence of symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria are as follows:\n\n* Age: 16 - 80 years\n* Subject is having a clinically indicated endoscopy for suspicious EoE and has been on twice daily (BID) proton pump inhibitor (PPI) for at least 8 weeks OR New diagnosis of EoE as per consensus guidelines. Cases must have symptoms of dysphagia, persistent esophageal eosinophilia (≥ 15 eosinophils in at least one high-power field) after 8 weeks of treatment with a twice daily proton-pump inhibitor, and other competing causes of esophageal eosinophilia excluded.\n\nExclusion criteria are as follows:\n\n* Medical instability that precludes safely performing upper endoscopy\n* Ongoing or recent symptoms of intestinal bleeding (throwing up blood, passing blood in the stool)\n* Concomitant eosinophilic gastroenteritis\n* Esophageal narrowing or stricturing that will not allow a standard 9 mm upper endoscopy scope to pass\n* Cancer in the esophagus, stomach, or intestine\n* Previous esophageal surgery\n* Esophageal varices (dilated blood vessels in the esophagus)\n* Current use of blood thinners like Plavix or Coumadin that are not stopped prior to endoscopy procedures\n* Any corticosteroid exposure within the 4 weeks prior to their baseline endoscopic exam. Exclusionary corticosteroid exposure is defined as any swallowed topical steroids for EoE or systemic steroids for any condition within the four weeks prior to the baseline endoscopy. Corticosteroids used for asthma or intranasal corticosteroids are not an exclusion and are allowable.\n* Pregnancy\n* Inability to read or understand English'}, 'identificationModule': {'nctId': 'NCT02019758', 'briefTitle': 'Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis', 'orgStudyIdInfo': {'id': '13-4047'}, 'secondaryIdInfos': [{'id': 'R01DK101856', 'link': 'https://reporter.nih.gov/quickSearch/R01DK101856', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Viscous Budesonide (OVB)', 'description': 'Subjects will be treated with OVB at a dose of 1 mg twice daily, and they will also be instructed to use a placebo inhaler identical to the fluticasone MDI, with instructions to swallow 4 puffs twice daily.', 'interventionNames': ['Drug: Oral Viscous Budesonide', 'Drug: Placebo inhaler']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Fluticasone MDI', 'description': 'Subjects will be treated with fluticasone MDI at a dose of 880 mcg twice daily (4 puffs of a 220 mcg inhaler twice daily), and they will also be instructed to take 4 mL twice daily of a placebo slurry of sucralose identical in consistency and taste to the OVB.', 'interventionNames': ['Drug: Fluticasone MDI', 'Drug: Placebo slurry']}], 'interventions': [{'name': 'Oral Viscous Budesonide', 'type': 'DRUG', 'otherNames': ['Pulmicort'], 'description': 'Oral Viscous Budesonide - 1 mg/4 mL, 4 mL of slurry twice daily', 'armGroupLabels': ['Oral Viscous Budesonide (OVB)']}, {'name': 'Fluticasone MDI', 'type': 'DRUG', 'otherNames': ['Flovent'], 'description': 'Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily)', 'armGroupLabels': ['Active Fluticasone MDI']}, {'name': 'Placebo slurry', 'type': 'DRUG', 'otherNames': ['Sucralose'], 'description': 'Slurry of sucralose - 4 mL twice daily', 'armGroupLabels': ['Active Fluticasone MDI']}, {'name': 'Placebo inhaler', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Placebo inhaler - 4 puffs twice daily', 'armGroupLabels': ['Oral Viscous Budesonide (OVB)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina, Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Evan S Dellon, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}