Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-31 @ 2:54 AM
Study NCT ID:
NCT01270256
Status:
COMPLETED
Last Update Posted:
2014-07-25
First Post:
2011-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
NasoNeb Delivery of an Intranasal Steroid
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, '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': 'rnackeri@surgery.bsd.uchicago.edu', 'phone': '773-702-0080', 'title': 'Dr. Robert M Naclerio', 'organization': 'University of Chicago'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Budesonide', 'description': 'Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo delivered intranasally via NasoNeb nebulizer once daily', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Nasal Peak Inspiratory Flow (NPIF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide', 'description': 'Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo delivered intranasally via NasoNeb nebulizer once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '36.41', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '18.71', 'spread': '8.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 26 days', 'description': 'NPIF was measured objectively in liters per minute with an In-Check Peak \\& Inspiratory Flow Meter (Ferraris Medical Inc, Orchard Park, NY). Subjects obtained 3 readings every morning and every evening and the greatest of the 3 measures were recorded. Total daily NPIF was calculated by adding the morning and evening values each day and the average of the change from baseline in NPIF for all days of was calculated', 'unitOfMeasure': 'liters/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Budesonide', 'description': 'Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo delivered intranasally via NasoNeb nebulizer once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Budesonide', 'description': 'Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo delivered intranasally via NasoNeb nebulizer once daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '55'}, {'value': '32.3', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '52'}, {'value': '32.8', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '55'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-17', 'studyFirstSubmitDate': '2011-01-03', 'resultsFirstSubmitDate': '2014-06-16', 'studyFirstSubmitQcDate': '2011-01-04', 'lastUpdatePostDateStruct': {'date': '2014-07-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-16', 'studyFirstPostDateStruct': {'date': '2011-01-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Nasal Peak Inspiratory Flow (NPIF)', 'timeFrame': 'Baseline and 26 days', 'description': 'NPIF was measured objectively in liters per minute with an In-Check Peak \\& Inspiratory Flow Meter (Ferraris Medical Inc, Orchard Park, NY). Subjects obtained 3 readings every morning and every evening and the greatest of the 3 measures were recorded. Total daily NPIF was calculated by adding the morning and evening values each day and the average of the change from baseline in NPIF for all days of was calculated'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['allergy'], 'conditions': ['Perennial Allergic Rhinitis']}, 'referencesModule': {'references': [{'pmid': '24574125', 'type': 'DERIVED', 'citation': 'Brown K, Lane J, Silva MP, DeTineo M, Naclerio RM, Baroody FM. A pilot study of the effects of intranasal budesonide delivered by NasoNeb(R) on patients with perennial allergic rhinitis. Int Forum Allergy Rhinol. 2014 Jan;4(1):43-8. doi: 10.1002/alr.21239.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if a nasal steroid drug delivered to the nose with the NasoNeb™ inhaler improves the symptoms of people with perennial allergic rhinitis (year round allergy symptoms).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Males and females between 18 and 55 years of age.\n2. History of perennial allergic rhinitis.\n3. Positive skin test to dust mite, dog, cat or indoor mold antigen.\n4. And a combined nasal AM and PM score of ≥4 for nasal congestion in the day preceding entry and total nasal symptom score greater than 8.\n\nExclusion Criteria\n\n1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.\n2. Pregnant or lactating women.\n3. Subjects treated with systemic steroids during the previous 30 days.\n4. Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 30 days.\n5. Subjects treated with oral antihistamine/decongestants during the previous seven days.\n6. Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days.\n7. Subjects treated with immunotherapy and are escalating their dose.\n8. Subjects on chronic anti-asthma medications.\n9. Subjects with polyps in the nose or a significantly displaced septum.\n10. Upper respiratory infection within 14 days prior to study start.'}, 'identificationModule': {'nctId': 'NCT01270256', 'briefTitle': 'NasoNeb Delivery of an Intranasal Steroid', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Evaluation of NasoNeb™ Delivery of an Intranasal Steroid in the Treatment of Perennial Allergic Rhinitis', 'orgStudyIdInfo': {'id': '10-660-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Budesonide', 'description': 'Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily', 'interventionNames': ['Drug: Budesonide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo delivered intranasally via NasoNeb nebulizer once daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Budesonide', 'type': 'DRUG', 'description': 'Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily', 'armGroupLabels': ['Budesonide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo delivered intranasally via NasoNeb nebulizer once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Robert M Naclerio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'MedInvent, LLC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}