Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT00425620
Status:
COMPLETED
Last Update Posted:
2007-11-30
First Post:
2007-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Amphotericin B Suspension in Refractory Chronic Sinusitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-29', 'studyFirstSubmitDate': '2007-01-19', 'studyFirstSubmitQcDate': '2007-01-22', 'lastUpdatePostDateStruct': {'date': '2007-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of the study is to evaluate the safety and efficacy of Amphotericin B suspension versus placebo in the complete resolution of key chronic sinusitis symptoms during 16 weeks of treatment in patients with refractory, postsurgical CS.', 'timeFrame': 'Four months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Sinusitis', 'Chronic Rhinosinusitis'], 'conditions': ['Chronic Sinusitis']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the safety and efficacy of Amphotericin B suspension versus placebo in the complete resolution of key chronic sinusitis symptoms during 16 weeks of treatment in patients with refractory, postsurgical CS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has a diagnosis of refractory, postsurgical chronic sinusitis\n* Has a documented history of chronic sinusitis symptoms for more than 12 weeks\n* A CT scan showing a certain level of mucosal thickening in at least 1 maxillary sinus\n* An endoscopy documenting the presence of inflammation and absence of stage 4 polyps\n* Ability to comply with the study requirements including the ability to administer a nasal lavage twice daily for 4 months\n* Females of childbearing potential must use adequate birth control methods and not plan to get pregnant during the course of the study.\n* Ability to read or speak English\n\nExclusion Criteria:\n\n* Has a hypersensitivity to Amphotericin B or the compounds of any study medications\n* Is an immunosuppressed patient or is receiving disease modifying agents\n* Has an acute upper or lower respiratory illness\n* Has an acute exacerbation of chronic sinusitis within 1 month prior to randomization\n* Has used systemic antibiotic therapy for reasons other than acute sinusitis within 3 weeks prior to randomization\n* Has used any antibiotic therapy for acute complication of chronic sinusitis within 1 month prior to randomization\n* Has orbital or central nervous system complications\n* Has acute asthma at study initiation\n* Began using nasal corticosteroids or had a dosage change within 3 months prior to randomization\n* Has taken a dose of oral or intravenous steroids to treat any condition other than asthma within 1 month prior to randomization\n* Has used any systemic antifungal therapy within 3 months prior to randomization\n* Has used intranasal antifungal therapy for chronic sinusitis within 3 months prior to randomization\n* Currently has a clinically significant deviated nasal septum that has not been remedied by surgery\n* Has an anatomical abnormality which would significantly obstruct the nasal passages\n* Has cystic fibrosis\n* Is pregnant\n* Has stage 4 polyposis\n* Has any significant medical condition that in a doctor's opinion could affect the patient's participation in the trial\n* Has used any investigational product within 1 month of study initiation\n* Has a history of cancer other than treated squamous cell or basal cell carcinoma of the skin that has not been in full remission for at least 5 years prior to study initiation"}, 'identificationModule': {'nctId': 'NCT00425620', 'briefTitle': 'Amphotericin B Suspension in Refractory Chronic Sinusitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Accentia Biopharmaceuticals'}, 'officialTitle': 'A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study of Intranasal Amphotericin B Suspension in Patients With Refractory, Postsurgical Chronic Sinusitis (CS)', 'orgStudyIdInfo': {'id': 'ACC-05-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amphotericin B', 'interventionNames': ['Drug: SinuNase']}], 'interventions': [{'name': 'SinuNase', 'type': 'DRUG', 'otherNames': ['Amphotericin B Suspension'], 'description': 'Lavage', 'armGroupLabels': ['Amphotericin B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35215', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Parkway Medical Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35244', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama ENT Associates', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical Research Advantage', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'NEA Clinic', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '93301', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Kern Allergy Medical Clinic', 'geoPoint': {'lat': 35.37329, 'lon': 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