Ignite Creation Date:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2026-02-26 @ 5:46 PM
Study NCT ID:
NCT01197612
Status:
COMPLETED
Last Update Posted:
2018-05-29
First Post:
2010-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019819', 'term': 'Budesonide'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ggriffin@mw-fp.com', 'title': 'Garrett Griffin, MD', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This was a pilot study with less enrollment than desired and poor rate of completion with only 5 participants completing the full 24 week trial. This study could be done on a larger/similar scale with some additional useful data obtained.'}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Single Arm; Nostrils as Experimental and Comparator', 'description': 'each subject serves as their own control with one nostril being treated with pulmicort and one not\n\npulmicort: applied to nasal packing after surgery', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Olfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Nostril (Pulmicort)', 'description': 'each subject serves as their own control with one nostril being treated with pulmicort and one not\n\npulmicort: applied to nasal packing after surgery'}, {'id': 'OG001', 'title': 'Untreated Nostril (no Pulmicort)', 'description': 'each subject serves as their own control with one nostril being treated with pulmicort and one not\n\npulmicort: applied to nasal packing after surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '36'}, {'value': '19.8', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '37'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks post-operation', 'description': 'will be measured with the University of Pennsylvania Smell Identification Test (UPSIT), whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "Of sixteen participants at the three week mark, one participant's data was unable to be unblinded accurately, and one participant had no UPSIT scores taken, leaving an analysis population of 14,"}, {'type': 'SECONDARY', 'title': 'Sinonasal Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Nostril (Pulmicort)', 'description': 'each subject serves as their own control with one nostril being treated with pulmicort and one not\n\npulmicort: applied to nasal packing after surgery'}, {'id': 'OG001', 'title': 'Placebo Treated Nostril (no Pulmicort)', 'description': 'each subject serves as their own control with one nostril being treated with pulmicort and one not\n\npulmicort: applied to nasal packing after surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '4.7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks post operation', 'description': 'will be assessed with the Perioperative Sinus Endoscopy score (POSE), a 20 point scale where 0 is no sinus challenges and 20 represents the greatest blockage.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "unblinding could not be done on one person accurately, so only 15 rather than 16 people's data could be analyzed"}, {'type': 'SECONDARY', 'title': 'Olfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Nostril (Pulmicort)', 'description': 'each subject serves as their own control with one nostril being treated with pulmicort and one not\n\npulmicort: applied to nasal packing after surgery'}, {'id': 'OG001', 'title': 'Placebo/Untreated Nostril (no Pulmicort)', 'description': 'each subject serves as their own control with one nostril being treated with pulmicort and one not\n\npulmicort: applied to nasal packing after surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '37'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '38'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks post operation', 'description': 'Scored with the University of Pennsylvania Smell Identification Test, whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "Of six participants remaining at 24 weeks, one participant's data could not be accurately unblinded leaving analysis of 5"}, {'type': 'SECONDARY', 'title': 'Sinonasal Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treated Nostril (Pulmicort)', 'description': 'each subject serves as their own control with one nostril being treated with pulmicort and one not\n\npulmicort: applied to nasal packing after surgery'}, {'id': 'OG001', 'title': 'Untreated Nostril (no Pulmicort)', 'description': 'each subject serves as their own control with one nostril being treated with pulmicort and one not\n\npulmicort: applied to nasal packing after surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '11'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '11'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks post operation', 'description': 'Assessed with Perioperative Sinus Endoscopy (POSE) score', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "Of six participants at 24 weeks, one's data was unable to be unblinded accurately, leaving an analysis population of 5 participants"}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Arm; Nostrils as Experimental and Comparator', 'description': 'each subject serves as their own control with one nostril being treated with pulmicort and one not\n\npulmicort: applied to nasal packing after surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Week 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Returned for Week 24', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}]}], 'preAssignmentDetails': 'Of 23 participants who consented, data is only available for 20. Two never had surgery, and so were not "assigned" at all.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm; Nostrils as Experimental and Comparator', 'description': 'each subject serves as their own control with one nostril being treated with pulmicort and one not\n\npulmicort: applied to nasal packing after surgery'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-24', 'studyFirstSubmitDate': '2010-08-30', 'resultsFirstSubmitDate': '2018-04-24', 'studyFirstSubmitQcDate': '2010-09-08', 'lastUpdatePostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-24', 'studyFirstPostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Olfaction', 'timeFrame': '3 weeks post-operation', 'description': 'will be measured with the University of Pennsylvania Smell Identification Test (UPSIT), whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification'}], 'secondaryOutcomes': [{'measure': 'Sinonasal Health', 'timeFrame': '3 weeks post operation', 'description': 'will be assessed with the Perioperative Sinus Endoscopy score (POSE), a 20 point scale where 0 is no sinus challenges and 20 represents the greatest blockage.'}, {'measure': 'Olfaction', 'timeFrame': '24 weeks post operation', 'description': 'Scored with the University of Pennsylvania Smell Identification Test, whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification'}, {'measure': 'Sinonasal Health', 'timeFrame': '24 weeks post operation', 'description': 'Assessed with Perioperative Sinus Endoscopy (POSE) score'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Sinusitis', 'Polyposis']}, 'descriptionModule': {'briefSummary': 'That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hyposmia and nasal obstruction for \\>12 weeks\n* bilateral nasal polyposis\n* candidate for surgery\n\nExclusion Criteria:\n\n* immunocompromised\n* non-English speaking\n* prisoner\n* pregnant/lactating\n* will not attend follow up appointments'}, 'identificationModule': {'nctId': 'NCT01197612', 'briefTitle': 'Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis', 'orgStudyIdInfo': {'id': 'HUM00029273'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single Arm; nostrils as experimental and comparator', 'description': 'each subject serves as their own control with one nostril being treated with pulmicort and one not', 'interventionNames': ['Drug: pulmicort']}], 'interventions': [{'name': 'pulmicort', 'type': 'DRUG', 'otherNames': ['budesonide'], 'description': 'applied to nasal packing after surgery', 'armGroupLabels': ['Single Arm; nostrils as experimental and comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48103', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Garrett R Griffin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Rhinologic Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident/Research Fellow', 'investigatorFullName': 'Garrett Griffin', 'investigatorAffiliation': 'University of Michigan'}}}}