Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2026-01-07 @ 6:49 PM
Study NCT ID:
NCT03028350
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2017-01-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055963', 'term': 'Asthma, Aspirin-Induced'}], 'ancestors': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D004342', 'term': 'Drug Hypersensitivity'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C078904', 'term': 'ifetroban'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bgibson@cumberlandpharma.com', 'phone': '6154257644', 'title': 'Senior Clinical Scientist', 'organization': 'Cumberland Pharmaceuticals'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Planned enrollment for the study was 76 subjects with 38 subjects per treatment arm. Due to enrollment challenges during and following the COVID-19 pandemic, the study was closed with 56 subjects enrolled.'}}, 'adverseEventsModule': {'timeFrame': 'Through 10 weeks (8 weeks of treatment, 2 weeks of follow-up)', 'description': "The severity of each event is reported by the investigator according to the following definitions:\n\n* Mild: Transient symptoms, no interference with the subject's daily activities.\n* Moderate: Marked symptoms, moderate interference with the subject's daily activities.\n* Severe: Considerable interference with the subject's daily activities, unacceptable.", 'eventGroups': [{'id': 'EG000', 'title': 'Ifetroban Oral Capsule', 'description': 'Oral ifetroban, 200 mg daily for 8 weeks\n\nIfetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 7, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo Oral Capsule', 'description': 'Oral placebo daily for 8 weeks\n\nPlacebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 11, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'seriousEvents': [{'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Sinonasal Outcome Test-22 Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ifetroban Oral Capsule', 'description': 'Oral ifetroban, 200 mg daily for 8 weeks\n\nIfetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'Oral placebo daily for 8 weeks\n\nPlacebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.7', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '-13.7', 'spread': '22.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Sinonasal Outcome Test-22 (SNOT-22) score is a scale with a minimum score of 0 and a maximum score of 110 based on the presence and severity of symptoms and outcomes of rhinosinusitis. Higher scores indicate worse symptoms and/or outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled with SNOT-22 measurements at both baseline and 8 weeks were included. Three enrolled subjects treated with ifetroban did not have SNOT-22 measurements for both timepoints and therefore were not analyzed for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Asthma Control Questionnaire -7 Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ifetroban Oral Capsule', 'description': 'Oral ifetroban, 200 mg daily for 8 weeks\n\nIfetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'Oral placebo daily for 8 weeks\n\nPlacebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.30', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '1.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 weeks', 'description': 'The Asthma Control Questionnaire-7 is a scoring system with a minimum score of 0 and a maximum score of 6 based on the severity and frequency of asthma symptoms. Higher scores indicate worse control of asthma symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled with Asthma Control Questionnaire-7 measurements at both baseline and 8 weeks were included. Ten enrolled subjects treated with ifetroban and 5 enrolled subjects treated with placebo did not have Asthma Control Questionnaire-7 measurements for both timepoints and therefore were not analyzed for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Nasal Symptom Score (Morning)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ifetroban Oral Capsule', 'description': 'Oral ifetroban, 200 mg daily for 8 weeks\n\nIfetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'Oral placebo daily for 8 weeks\n\nPlacebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.28', 'spread': '1.85', 'groupId': 'OG000'}, {'value': '-2.57', 'spread': '3.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 weeks', 'description': 'The Total Nasal Symptom Score is a scoring system with a minimum score of 0 and maximum score of 15 based on severity of nasal symptoms. Higher scores indicate worse nasal symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled with Total Nasal Symptom Score (morning) measurements at both baseline and 8 weeks were included. Five enrolled subjects treated with ifetroban and 9 enrolled subjects treated with placebo did not have Total Nasal Symptom Score (morning) measurements for both timepoints and therefore were not analyzed for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ifetroban Oral Capsule', 'description': 'Oral ifetroban, 200 mg daily for 8 weeks\n\nIfetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'Oral placebo daily for 8 weeks\n\nPlacebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.010', 'spread': '0.421', 'groupId': 'OG000'}, {'value': '0.004', 'spread': '0.323', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change From Baseline in Forced Expiratory Volume in 1 second (FEV1) at 8 weeks', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled with FEV1 measurements at both baseline and 8 weeks were included. Four enrolled subjects treated with ifetroban and 1 enrolled subject treated with placebo did not have FEV1 measurements at both times and therefore were not analyzed for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Peak Nasal Inspiratory Flow Rate (PNIFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ifetroban Oral Capsule', 'description': 'Oral ifetroban, 200 mg daily for 8 weeks\n\nIfetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'Oral placebo daily for 8 weeks\n\nPlacebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '11.4', 'spread': '48.3', 'groupId': 'OG000'}, {'value': '-3.70', 'spread': '29.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change From Baseline in Peak Nasal Inspiratory Flow Rate (PNIFR) at 8 weeks', 'unitOfMeasure': 'liters/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled with PNIFR measurements at both baseline and 8 weeks were included. Five enrolled subjects treated with ifetroban and 1 enrolled subject treated with placebo did not have PNIFR measurements for both timepoints and therefore were not analyzed for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ifetroban Oral Capsule', 'description': 'Oral ifetroban, 200 mg daily for 8 weeks\n\nIfetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'Oral placebo daily for 8 weeks\n\nPlacebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '5.70', 'spread': '9.32', 'groupId': 'OG000'}, {'value': '1.40', 'spread': '17.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at 8 weeks', 'unitOfMeasure': 'parts per billion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled with FeNO measurements at both baseline and 8 weeks were included. Six enrolled subjects treated with ifetroban and 2 enrolled subjects treated with placebo did not have FeNO measurements for both timepoints and therefore were not analyzed for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Nasal Symptom Score (Afternoon/Evening)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ifetroban Oral Capsule', 'description': 'Oral ifetroban, 200 mg daily for 8 weeks\n\nIfetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'Oral placebo daily for 8 weeks\n\nPlacebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.519', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '-1.58', 'spread': '2.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 weeks', 'description': 'The Total Nasal Symptom Score is a scale with a minimum score of 0 and maximum score of 15 based on severity of nasal symptoms. Higher scores indicate worse nasal symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled with Total Nasal Symptom Score (afternoon/evening) measurements at both baseline and 8 weeks were included. Eleven enrolled subjects treated with ifetroban and 6 enrolled subjects treated with placebo did not have Total Nasal Symptom Score (afternoon/evening) measurements for both timepoints and therefore were not analyzed for this outcome.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Blood Eosinophil Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ifetroban Oral Capsule', 'description': 'Oral ifetroban, 200 mg daily for 8 weeks\n\nIfetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': 'Oral placebo daily for 8 weeks\n\nPlacebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change From Baseline in Blood Eosinophil Count at 8 Weeks', 'unitOfMeasure': 'x10^9 cells/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled with blood eosinophil measurements at both baseline and 8 weeks were included. Eleven enrolled subjects treated with ifetroban and 13 enrolled subjects treated with placebo did not have blood eosinophil measurements for both timepoints and therefore were not analyzed for this outcome.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ifetroban Oral Capsule', 'description': 'Oral ifetroban, 200 mg daily for 8 weeks\n\nIfetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks'}, {'id': 'FG001', 'title': 'Placebo Oral Capsule', 'description': 'Oral placebo daily for 8 weeks\n\nPlacebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ifetroban Oral Capsule', 'description': 'Oral ifetroban, 200 mg daily for 8 weeks\n\nIfetroban Oral Capsule: Subjects will be treated with oral ifetroban daily for 8 weeks'}, {'id': 'BG001', 'title': 'Placebo Oral Capsule', 'description': 'Oral placebo daily for 8 weeks\n\nPlacebo Oral Capsule: Subjects will be treated with oral placebo daily for 8 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '70'}, {'value': '45', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '80'}, {'value': '51', 'groupId': 'BG002', 'lowerLimit': '24', 'upperLimit': '80'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '45', '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': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '84.2', 'groupId': 'BG000', 'lowerLimit': '48.2', 'upperLimit': '127.3'}, {'value': '85.4', 'groupId': 'BG001', 'lowerLimit': '52.9', 'upperLimit': '137.2'}, {'value': '84.4', 'groupId': 'BG002', 'lowerLimit': '48.2', 'upperLimit': '137.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg', 'dispersionType': 'FULL_RANGE'}, {'title': 'BMI (kg/m2), Categorical >=30; <30', 'classes': [{'categories': [{'title': '>=30', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': '<30', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI (kg/m2), Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.8', 'groupId': 'BG000', 'lowerLimit': '18.8', 'upperLimit': '43.5'}, {'value': '27.0', 'groupId': 'BG001', 'lowerLimit': '19.7', 'upperLimit': '44.5'}, {'value': '27.8', 'groupId': 'BG002', 'lowerLimit': '18.8', 'upperLimit': '44.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-02', 'size': 902240, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-17T09:09', 'hasProtocol': True}, {'date': '2017-09-21', 'size': 576046, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-06-05T13:05', 'hasProtocol': False}]}}, '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': '2017-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-27', 'studyFirstSubmitDate': '2017-01-19', 'resultsFirstSubmitDate': '2024-06-05', 'studyFirstSubmitQcDate': '2017-01-19', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-05', 'studyFirstPostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in Blood Eosinophil Count', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change From Baseline in Blood Eosinophil Count at 8 Weeks'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Sinonasal Outcome Test-22 Score', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Sinonasal Outcome Test-22 (SNOT-22) score is a scale with a minimum score of 0 and a maximum score of 110 based on the presence and severity of symptoms and outcomes of rhinosinusitis. Higher scores indicate worse symptoms and/or outcomes.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Asthma Control Questionnaire -7 Score', 'timeFrame': 'Baseline and 8 weeks', 'description': 'The Asthma Control Questionnaire-7 is a scoring system with a minimum score of 0 and a maximum score of 6 based on the severity and frequency of asthma symptoms. Higher scores indicate worse control of asthma symptoms.'}, {'measure': 'Change From Baseline in Total Nasal Symptom Score (Morning)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'The Total Nasal Symptom Score is a scoring system with a minimum score of 0 and maximum score of 15 based on severity of nasal symptoms. Higher scores indicate worse nasal symptoms.'}, {'measure': 'Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change From Baseline in Forced Expiratory Volume in 1 second (FEV1) at 8 weeks'}, {'measure': 'Change From Baseline in Peak Nasal Inspiratory Flow Rate (PNIFR)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change From Baseline in Peak Nasal Inspiratory Flow Rate (PNIFR) at 8 weeks'}, {'measure': 'Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at 8 weeks'}, {'measure': 'Change From Baseline in Total Nasal Symptom Score (Afternoon/Evening)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'The Total Nasal Symptom Score is a scale with a minimum score of 0 and maximum score of 15 based on severity of nasal symptoms. Higher scores indicate worse nasal symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma, Aspirin-Induced']}, 'descriptionModule': {'briefSummary': 'The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for the treatment of aspirin-exacerbated respiratory disease (AERD). AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other nonsteroidal anti-inflammatory drugs.', 'detailedDescription': 'This is a randomized, placebo-controlled, double-blind phase 2 trial evaluating approximately 76 subjects with symptomatic AERD on the safety and efficacy of 8 weeks of oral ifetroban treatment. Eligible AERD subjects will be randomized to receive 8 weeks of either oral ifetroban daily or matching placebo followed by a 2-week post-treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. History of physician-diagnosed asthma\n2. History of nasal polyposis\n3. History of at least two reactions to oral aspirin or other nonselective cyclooxygenase inhibitor with features of lower airway involvement (cough, chest tightness, wheezing, dyspnea), or one reaction that was life-threatening and required hospitalization, or a diagnosis of AERD by a physician-conducted challenge to aspirin in the last five years before starting treatment.\n4. Stable asthma (post-bronchodilator forced expiratory volume in 1 second (FEV1) of ≥ 60%, no glucocorticoid burst for at least two weeks prior to starting treatment, no hospitalizations or emergency room visits for asthma at least three months prior to starting treatment and not on a dose \\>1000 µg fluticasone or equivalent daily).\n5. ≥ 18 years of age\n6. Exhibit symptomatic AERD within three weeks of starting treatment by demonstrating a score of at least 20 on the Sino-nasal Outcome Test (SNOT) - 22.\n\nExclusion Criteria:\n\n1. Current smoking, defined as daily tobacco smoking in the last six months and at least one instance of tobacco smoking in the last three months.\n2. Current pregnancy or breastfeeding\n3. Use of oral or systemic steroids (e.g. prednisone or equivalent) \\> 20 mg daily in the last four weeks before starting treatment.\n4. Daily use of long-acting antihistamines in the last two weeks before starting treatment.\n5. Less than 12 months of allergy shots (maintenance dose of allergy shots are allowed if treatment duration exceeds 12 months). Less than 1 month of 5-lipoxygenase inhibitors (e.g. zileuton) and/or leukotriene receptor antagonists (e.g. montelukast).\n6. Any use of nonsteroidal anti-inflammatory drugs (NSAIDs) or any drug that inhibits the cyclooxygenase enzyme in the last two weeks before starting treatment.\n7. History of bleeding diathesis or use of anticoagulant or antiplatelet drugs in the last two weeks before starting treatment.\n8. Any immunosuppressive treatment including but not limited to methotrexate, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine, hydroxychloroquine, azathioprine, and cyclophosphamide in the last two weeks before starting treatment (maintenance dose of allergy shots are allowed if treatment duration exceeds 12 months). Biologics/immunotherapies such as Xolair or Nucala are permitted if duration exceeds three months.\n9. Endoscopic sinus surgery / polypectomy within the past three months\n10. Previously treated in a clinical trial with ifetroban within the past three months.\n11. Previously treated with other investigational drugs within eight weeks or five half-lives, whichever is longer, before screening\n12. Conditions/concomitant disease which make them unevaluable for the efficacy endpoints'}, 'identificationModule': {'nctId': 'NCT03028350', 'briefTitle': 'Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cumberland Pharmaceuticals'}, 'officialTitle': 'A Phase 2 Multicenter, Double-blind, Randomized, Placebo-Controlled Trial to Evaluate Oral Ifetroban in Subjects With Symptomatic Aspirin Exacerbated Respiratory Disease (AERD)', 'orgStudyIdInfo': {'id': 'CPI-IFE-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ifetroban Oral Capsule', 'description': 'Oral ifetroban, 200 mg daily for 8 weeks', 'interventionNames': ['Drug: Ifetroban Oral Capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Oral Capsule', 'description': 'Oral placebo daily for 8 weeks', 'interventionNames': ['Drug: Placebo Oral Capsule']}], 'interventions': [{'name': 'Ifetroban Oral Capsule', 'type': 'DRUG', 'otherNames': ['Ifetroban'], 'description': 'Subjects will be treated with oral ifetroban daily for 8 weeks', 'armGroupLabels': ['Ifetroban Oral Capsule']}, {'name': 'Placebo Oral Capsule', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Subjects will be treated with oral placebo daily for 8 weeks', 'armGroupLabels': ['Placebo Oral Capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University of Arizona Medical Center, Asthma & Airway Disease Research Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'facility': 'Antelope Valley Clinical Trials', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '92130', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic - Carmel Valley', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '33013', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'The Research Center', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine, Sinus, Nasal, and Allergy Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '47713', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Deaconess Clinic', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '66210', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas City Allergy and Asthma Associates, PA', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '40207', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Advanced ENT & Allergy', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '14607', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Regional Health', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27104', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Health', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390-9035', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Medical Center', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Andrew White, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scripps Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cumberland Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}