Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2026-01-05 @ 5:53 PM
Study NCT ID:
NCT00626366
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2008-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Distribution of Topical Nasal Medication Within the Nasal Cavity and Sinuses by Radiographic Comparison
Sponsor:
Organization:
Raw JSON
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Following administration of the spray, the subjects will then have a Xoran mini-CAT scan of their sinuses.\n\nSinus CT Scan: Subjects will undergo a Xoran miniCAT scan of their sinuses\n\nOmnipaque 240 Contrast Solution: Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nasal Drop', 'description': 'This arm will contain subjects who will place two drops of a nasal contrast solution in each nose. Following administration of the nasal contrast, the subjects will then have a Xoran miniCAT scan of their sinuses.\n\nSinus CT Scan: Subjects will undergo a Xoran miniCAT scan of their sinuses\n\nOmnipaque 240 mg I/mL: Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each nose. Each drop is approximately 1 ml.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Measure the Distribution of Nasal Sprays and Drops.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'units': 'nasal cavities (right and left sides)', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nasal Spray', 'description': 'This arm of the study will contain subjects who will spray 2-4 sprays of a nasal contrast solution in their nares. Following administration of the spray, the subjects will then have a Xoran mini-CAT scan of their sinuses.\n\nSinus CT Scan: Subjects will undergo a Xoran miniCAT scan of their sinuses\n\nOmnipaque 240 Contrast Solution: Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml.'}, {'id': 'OG001', 'title': 'Nasal Drops', 'description': 'This arm will contain subjects who will place two drops of a nasal contrast solution in each nose. Following administration of the nasal contrast, the subjects will then have a Xoran miniCAT scan of their sinuses.\n\nSinus CT Scan: Subjects will undergo a Xoran miniCAT scan of their sinuses\n\nOmnipaque 240 mg I/mL: Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each nose. Each drop is approximately 1 ml.'}], 'classes': [{'title': 'Nasal vestibule', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Inferior upper nasal vault', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Superior upper nasal vault', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Anterior floor of nose', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Anterior inferior meatus', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Anterior inferior nasal cavity', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Posterior floor of nose', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Posterior inferior meatus', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Posterior inferior nasal cavity', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Anterior middle nasal cavity', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Anterior olfactory cleft', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Posterior middle nasal cavity', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Posterior olfactory cleft', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Anterior middle meatus', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Anterior ethmoid', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Osteomeatal complex', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Posterior middle meatus', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Posterior ethmoid', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Frontal recess', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Sphenoethmoid recess', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Nasopharynx', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 months', 'description': 'CT scan scored for distribution contrast delivered by nasal spray or drops within subsets in the nasal cavity. The sinonasal cavity was divided into twenty-one subsites on each side of the nasal cavity. The interpreters scored for the presence (1) or absence (0) of contrast from the nasal spray or nasal drops within each subsite. Left and right sides were interpreted separately for a possible total score of 0-42 for each CT scan.', 'unitOfMeasure': 'nasal cavities (right and left sides)', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'nasal cavities (right and left sides)', 'denomUnitsSelected': 'nasal cavities (right and left sides)', 'populationDescription': "Each participant's CT scan will be scored for left and right sides for a total of 18 sinonasal cavities"}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nasal Spray', 'description': 'This arm of the study will contain subjects who will spray 2-4 sprays of a nasal contrast solution in their nares. Following administration of the spray, the subjects will then have a Xoran mini-CAT scan of their sinuses.\n\nSinus CT Scan: Subjects will undergo a Xoran miniCAT scan of their sinuses\n\nOmnipaque 240 Contrast Solution: Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml.'}, {'id': 'FG001', 'title': 'Nasal Drops', 'description': 'This arm will contain subjects who will place two drops of a nasal contrast solution in each nose. Following administration of the nasal contrast, the subjects will then have a Xoran miniCAT scan of their sinuses.\n\nSinus CT Scan: Subjects will undergo a Xoran miniCAT scan of their sinuses\n\nOmnipaque 240 mg I/mL: Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each nose. Each drop is approximately 1 ml.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nasal Spray', 'description': 'This arm of the study will contain subjects who will spray 2-4 sprays of a nasal contrast solution in their nares. Following administration of the spray, the subjects will then have a Xoran mini-CAT scan of their sinuses.\n\nSinus CT Scan: Subjects will undergo a Xoran miniCAT scan of their sinuses\n\nOmnipaque 240 Contrast Solution: Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml.'}, {'id': 'BG001', 'title': 'Nasal Drops', 'description': 'This arm will contain subjects who will place two drops of a nasal contrast solution in each nose. Following administration of the nasal contrast, the subjects will then have a Xoran miniCAT scan of their sinuses.\n\nSinus CT Scan: Subjects will undergo a Xoran miniCAT scan of their sinuses\n\nOmnipaque 240 mg I/mL: Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each nose. Each drop is approximately 1 ml.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '50'}, {'value': '28.6', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '50'}, {'value': '28.6', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '50'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', '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.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2009-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2008-02-20', 'resultsFirstSubmitDate': '2018-10-29', 'studyFirstSubmitQcDate': '2008-02-20', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-24', 'studyFirstPostDateStruct': {'date': '2008-02-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Measure the Distribution of Nasal Sprays and Drops.', 'timeFrame': '2 months', 'description': 'CT scan scored for distribution contrast delivered by nasal spray or drops within subsets in the nasal cavity. The sinonasal cavity was divided into twenty-one subsites on each side of the nasal cavity. The interpreters scored for the presence (1) or absence (0) of contrast from the nasal spray or nasal drops within each subsite. Left and right sides were interpreted separately for a possible total score of 0-42 for each CT scan.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nasal Spray', 'Nasal Drop', 'Intranasal Medication'], 'conditions': ['Chronic Sinusitis']}, 'referencesModule': {'references': [{'pmid': '16360518', 'type': 'RESULT', 'citation': 'Senocak D, Senocak M, Bozan S. Sinonasal distribution of topically applied particles: computerized tomographic detection and the effects of topical decongestion. Otolaryngol Head Neck Surg. 2005 Dec;133(6):944-8. doi: 10.1016/j.otohns.2005.08.024.'}, {'pmid': '12172251', 'type': 'RESULT', 'citation': 'Olson DE, Rasgon BM, Hilsinger RL Jr. Radiographic comparison of three methods for nasal saline irrigation. Laryngoscope. 2002 Aug;112(8 Pt 1):1394-8. doi: 10.1097/00005537-200208000-00013.'}, {'pmid': '15564850', 'type': 'RESULT', 'citation': 'Wormald PJ, Cain T, Oates L, Hawke L, Wong I. A comparative study of three methods of nasal irrigation. Laryngoscope. 2004 Dec;114(12):2224-7. doi: 10.1097/01.mlg.0000149463.95950.c5.'}, {'pmid': '16500451', 'type': 'RESULT', 'citation': 'Boatsman JE, Calhoun KH, Ryan MW. Relationship between rhinosinusitis symptoms and mucociliary clearance time. Otolaryngol Head Neck Surg. 2006 Mar;134(3):491-3. doi: 10.1016/j.otohns.2005.10.045.'}, {'pmid': '15224630', 'type': 'RESULT', 'citation': 'Lund VJ, Black JH, Szabo LZ, Schrewelius C, Akerlund A. Efficacy and tolerability of budesonide aqueous nasal spray in chronic rhinosinusitis patients. Rhinology. 2004 Jun;42(2):57-62.'}, {'pmid': '15182211', 'type': 'RESULT', 'citation': 'Aukema AA, Fokkens WJ. Chronic rhinosinusitis: management for optimal outcomes. Treat Respir Med. 2004;3(2):97-105. doi: 10.2165/00151829-200403020-00004.'}, {'pmid': '16274802', 'type': 'RESULT', 'citation': 'Cannady SB, Batra PS, Citardi MJ, Lanza DC. Comparison of delivery of topical medications to the paranasal sinuses via "vertex-to-floor" position and atomizer spray after FESS. Otolaryngol Head Neck Surg. 2005 Nov;133(5):735-40. doi: 10.1016/j.otohns.2005.07.039.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the distribution of nasal sprays and nasal drops when used.', 'detailedDescription': 'The purpose of this study is to determine the distribution of nasal sprays and nasal drops when used. The study hypothesizes that nasal drops will reach the frontonasal region more often than nasal sprays.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult able to perform activities of daily living\n\nExclusion Criteria:\n\n* signs or symptoms of acute or chronic paranasal sinus disease\n* history of sinus surgery\n* symptomatic deviated septum\n* active seasonal allergies\n* allergies to contrast\n* history of nasal polyposis\n* pregnant or breast feeding women\n* neck or back problems that would prevent a subject from kneeling on the floor and crouching over\n* currently taking metformin or amiodarone\n* students or stff under the direct supervision of the investigators\n* cognitive impairment\n* terminal illness'}, 'identificationModule': {'nctId': 'NCT00626366', 'briefTitle': 'Distribution of Topical Nasal Medication Within the Nasal Cavity and Sinuses by Radiographic Comparison', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Distribution of Topical Nasal Medication Within the Nasal Cavity and Sinuses by Radiographic Comparison', 'orgStudyIdInfo': {'id': '0498-07-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nasal spray', 'description': 'This arm of the study will contain subjects who will spray 2-4 sprays of a nasal contrast solution in their nares. Following administration of the spray, the subjects will then have a Xoran mini-CAT scan of their sinuses.', 'interventionNames': ['Radiation: Sinus CT Scan', 'Drug: Omnipaque 240 Contrast Solution']}, {'type': 'EXPERIMENTAL', 'label': 'Nasal drop', 'description': 'This arm will contain subjects who will place two drops of a nasal contrast solution in each nose. Following administration of the nasal contrast, the subjects will then have a Xoran miniCAT scan of their sinuses.', 'interventionNames': ['Radiation: Sinus CT Scan', 'Drug: Omnipaque 240 mg I/mL']}], 'interventions': [{'name': 'Sinus CT Scan', 'type': 'RADIATION', 'description': 'Subjects will undergo a Xoran miniCAT scan of their sinuses', 'armGroupLabels': ['Nasal drop', 'Nasal spray']}, {'name': 'Omnipaque 240 Contrast Solution', 'type': 'DRUG', 'otherNames': ['contrast enhancement'], 'description': 'Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml.', 'armGroupLabels': ['Nasal spray']}, {'name': 'Omnipaque 240 mg I/mL', 'type': 'DRUG', 'otherNames': ['contrast enhancement'], 'description': 'Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each nose. Each drop is approximately 1 ml.', 'armGroupLabels': ['Nasal drop']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'ENT Specialist PC of Omaha', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': "Erin K O'Brien, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}, {'name': 'Donald Leopold, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}