Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-22 @ 5:22 PM
Study NCT ID:
NCT02061202
Status:
COMPLETED
Last Update Posted:
2019-03-11
First Post:
2014-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Inhaled Mometasone to Reduce Painful Episodes in Patients With Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068656', 'term': 'Mometasone Furoate'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeffrey.glassberg@mountsinai.org', 'phone': '212-241-3650', 'title': 'Dr. Jeffrey Glassberg', 'organization': 'Icahn School of Medicine at Mount Sinai'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Mometasone Furoate', 'description': '1 puff daily (220mcg) for 16 weeks', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 15, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 5, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hoarseness of voice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Thrush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Sore Throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Completed Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate', 'description': '1 puff daily (220mcg) for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 2 years', 'description': 'Feasibility is determined by calculating the proportion of randomized participants who complete follow up and a minimum of 30 pain diaries with good adherence to the study medication vs. the number enrolled.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Exhaled Nitric Oxide (eNO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate', 'description': '1 puff daily (220mcg) for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'groupId': 'OG000', 'lowerLimit': '-2.51', 'upperLimit': '3.77'}, {'value': '2.71', 'groupId': 'OG001', 'lowerLimit': '0.48', 'upperLimit': '5.90'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before ICS therapy begins and at 8 weeks post enrollment', 'description': 'Change in effects of inhaled corticosteroids (ICS) as measured by exhaled nitric oxide levels, which is the primary marker of pulmonary inflammation.', 'unitOfMeasure': 'ppb', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Soluble Vascular Cell Adhesion Molecule (sVCAM) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate', 'description': '1 puff daily (220mcg) for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)'}], 'classes': [{'categories': [{'measurements': [{'value': '-182.47', 'spread': '785.21', 'groupId': 'OG000'}, {'value': '170.25', 'spread': '182.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before ICS therapy begins and at 8 weeks post enrollment', 'description': 'Mean Change in effects of inhaled corticosteroids vascular injury, assessed by biomarker sVCAM as a surrogate for vascular injury.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate', 'description': '1 puff daily (220mcg) for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '22.7', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '24.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 20', 'description': 'Mean changes in ASCQ-Me (NHLBI developed a patient-reported Sickle Cell Disease (SCD) quality of life measurement tool) pain impact, at week 20 as compared to baseline. A reduction change on a 100-point scale indicated improved quality of life. ASCQ-Me uses a T-score metric (0-100) in which 50 is the mean of the reference population and 10 is the standard deviation (SD) of that population.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Medication Adherence Report Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate', 'description': '1 puff daily (220mcg) for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)'}], 'classes': [{'categories': [{'measurements': [{'value': '17.7', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '17.1', 'spread': '1.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 weeks', 'description': 'The medication adherence report scale for asthma is a 10 question tool scored between 0 and 5, with full scale from 0 to 25, with higher scores indicating greater adherence', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in the Numerical Rating Scale (NRS) for Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate', 'description': '1 puff daily (220mcg) for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.09', 'spread': '2.55', 'groupId': 'OG000'}, {'value': '2.82', 'spread': '2.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 20 weeks', 'description': 'Mean change in patient reported pain NRS score, full scale range 0- 10, higher score indicate more pain', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Asthma Control Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate', 'description': '1 puff daily (220mcg) for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)'}], 'classes': [{'categories': [{'measurements': [{'value': '17.7', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '17.1', 'spread': '1.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Asthma control test, total score from 0-25, with higher score indicating more symptoms', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Admissions or Visits to the Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate', 'description': '1 puff daily (220mcg) for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)'}], 'classes': [{'title': 'ED visits', 'categories': [{'measurements': [{'value': '0.97', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '1.87', 'groupId': 'OG001'}]}]}, {'title': 'Observation admits', 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '1.18', 'groupId': 'OG001'}]}]}, {'title': 'Admissions', 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '1.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline through 8 weeks', 'description': 'Number of times participant visited the Emergency Department (ED) or was admitted to the hospital', 'unitOfMeasure': 'Events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Reticulocytes Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate', 'description': '1 puff daily (220mcg) for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 8 weeks', 'description': 'Mean change in reticulocytes count - the number of new red blood cells.', 'unitOfMeasure': '10^3 cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in FEV1/FVC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate', 'description': '1 puff daily (220mcg) for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.71', 'spread': '3.42', 'groupId': 'OG000'}, {'value': '-1.41', 'spread': '3.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 8 weeks', 'description': 'Mean change in FEV1/FVC at 8 weeks compared to baseline', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mometasone Furoate', 'description': '1 puff daily (220mcg) for 16 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': '1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment began in February 2014, with first enrollment in March 2014, and last enrollment in October 2016'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mometasone Furoate', 'description': '1 puff daily (220mcg) for 16 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': '1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30', 'spread': '8.56', 'groupId': 'BG000'}, {'value': '36', 'spread': '9.81', 'groupId': 'BG001'}, {'value': '32', 'spread': '9.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': '1 participant in each group was lost to follow up prior to data collection and excluded from analyses.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-11-18', 'size': 1272182, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-10-10T09:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-08', 'studyFirstSubmitDate': '2014-01-14', 'resultsFirstSubmitDate': '2018-10-26', 'studyFirstSubmitQcDate': '2014-02-11', 'lastUpdatePostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-08', 'studyFirstPostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Completed Follow up', 'timeFrame': 'at 2 years', 'description': 'Feasibility is determined by calculating the proportion of randomized participants who complete follow up and a minimum of 30 pain diaries with good adherence to the study medication vs. the number enrolled.'}], 'secondaryOutcomes': [{'measure': 'Change in Exhaled Nitric Oxide (eNO)', 'timeFrame': 'Before ICS therapy begins and at 8 weeks post enrollment', 'description': 'Change in effects of inhaled corticosteroids (ICS) as measured by exhaled nitric oxide levels, which is the primary marker of pulmonary inflammation.'}, {'measure': 'Change in Soluble Vascular Cell Adhesion Molecule (sVCAM) Level', 'timeFrame': 'Before ICS therapy begins and at 8 weeks post enrollment', 'description': 'Mean Change in effects of inhaled corticosteroids vascular injury, assessed by biomarker sVCAM as a surrogate for vascular injury.'}, {'measure': 'Change in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me)', 'timeFrame': 'baseline and week 20', 'description': 'Mean changes in ASCQ-Me (NHLBI developed a patient-reported Sickle Cell Disease (SCD) quality of life measurement tool) pain impact, at week 20 as compared to baseline. A reduction change on a 100-point scale indicated improved quality of life. ASCQ-Me uses a T-score metric (0-100) in which 50 is the mean of the reference population and 10 is the standard deviation (SD) of that population.'}, {'measure': 'The Medication Adherence Report Scale', 'timeFrame': '20 weeks', 'description': 'The medication adherence report scale for asthma is a 10 question tool scored between 0 and 5, with full scale from 0 to 25, with higher scores indicating greater adherence'}, {'measure': 'Change in the Numerical Rating Scale (NRS) for Pain', 'timeFrame': 'baseline and 20 weeks', 'description': 'Mean change in patient reported pain NRS score, full scale range 0- 10, higher score indicate more pain'}, {'measure': 'Asthma Control Test', 'timeFrame': '8 weeks', 'description': 'Asthma control test, total score from 0-25, with higher score indicating more symptoms'}, {'measure': 'Admissions or Visits to the Hospital', 'timeFrame': 'baseline through 8 weeks', 'description': 'Number of times participant visited the Emergency Department (ED) or was admitted to the hospital'}, {'measure': 'Change in Reticulocytes Count', 'timeFrame': 'baseline and 8 weeks', 'description': 'Mean change in reticulocytes count - the number of new red blood cells.'}, {'measure': 'Change in FEV1/FVC', 'timeFrame': 'baseline and 8 weeks', 'description': 'Mean change in FEV1/FVC at 8 weeks compared to baseline'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sickle Cell Disease', 'Pain Crisis', 'Painful Crisis', 'Sickle Pain'], 'conditions': ['Sickle Cell Disease']}, 'referencesModule': {'references': [{'pmid': '30783732', 'type': 'DERIVED', 'citation': 'Langer AL, Leader A, Kim-Schulze S, Ginzburg Y, Merad M, Glassberg J. Inhaled steroids associated with decreased macrophage markers in nonasthmatic individuals with sickle cell disease in a randomized trial. Ann Hematol. 2019 Apr;98(4):841-849. doi: 10.1007/s00277-019-03635-9. Epub 2019 Feb 20.'}, {'pmid': '28370266', 'type': 'DERIVED', 'citation': 'Glassberg J, Minnitti C, Cromwell C, Cytryn L, Kraus T, Skloot GS, Connor JT, Rahman AH, Meurer WJ. Inhaled steroids reduce pain and sVCAM levels in individuals with sickle cell disease: A triple-blind, randomized trial. Am J Hematol. 2017 Jul;92(7):622-631. doi: 10.1002/ajh.24742. Epub 2017 Jun 5.'}]}, 'descriptionModule': {'briefSummary': 'The proposed research is designed to test the global hypothesis that inhaled corticosteroids (ICS), a therapy developed to treat asthma, will prevent vasoocclusive painful episodes in adults with Sickle Cell Disease (SCD) who wheeze, but do not meet criteria for a diagnosis of asthma. The specific aims of this proposal are 1) Conduct a feasibility study - a randomized controlled trial of ICS for adults with SCD who do not meet criteria for a diagnosis of asthma but report recurrent cough or wheezing, 2) Measure the effects of ICS on biological correlates of pulmonary inflammation (as determined by exhaled nitric oxide) and vascular injury (as determined by sVCAM) in SCD, and 3) Compare properties of traditional and Bayesian adaptive clinical trial design for therapeutic trials in SCD in preparation for designing a definitive trial of ICS. These aims have the potential to 1) change the standard of care for individuals with SCD and recurrent cough or wheeze, 2) provide insight into the pathogenesis of non-asthmatic wheezing in SCD and its response to treatment, 3) explore the suitability of innovative clinical trial designs to overcome the challenges that have hindered therapeutic innovation for SCD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 15 or older\n* Sever SCD phenotypes (Hb SS and Sβthalassemia0)\n* A positive response to cough/wheeze questions\n\nExclusion Criteria:\n\n* Patient carries a physician diagnosis of asthma\n* Patient is prescribed asthma medications\n* Patient is currently having a painful crisis (as defined by validated pain diary questions)\n* Patient has acute respiratory symptoms\n* Known hypersensitivity to milk proteins\n* Meets criteria for our operational diagnosis of asthma\n* More than 15 ED visits for pain over the preceding 12 months\n* Admitted or discharged from the hospital for SCD pain within the last 7 days'}, 'identificationModule': {'nctId': 'NCT02061202', 'acronym': 'IMPROVE', 'briefTitle': 'Inhaled Mometasone to Reduce Painful Episodes in Patients With Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Inhaled Mometasone to Promote Reduction in Vasoocclusive Events', 'orgStudyIdInfo': {'id': 'GCO 12-1565'}, 'secondaryIdInfos': [{'id': 'K23HL119351', 'link': 'https://reporter.nih.gov/quickSearch/K23HL119351', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mometasone Furoate', 'description': '1 puff daily (220mcg) for 16 weeks', 'interventionNames': ['Drug: Mometasone Furoate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Mometasone Furoate', 'type': 'DRUG', 'description': 'inhaled cortico-steroid (ICS) with a dosage of 220mcg once daily for 16 weeks', 'armGroupLabels': ['Mometasone Furoate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo training inhaler with the same instructions as the experimental group.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jeffrey Glassberg, MD, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jeffrey Glassberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jeffrey Glassberg', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}