Amphotericin B Suspension in Refractory Chronic Sinusitis
NCT ID: NCT00425620
Last Updated: 2007-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2006-12-31
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Amphotericin B
SinuNase
Lavage
Interventions
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SinuNase
Lavage
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a documented history of chronic sinusitis symptoms for more than 12 weeks
* A CT scan showing a certain level of mucosal thickening in at least 1 maxillary sinus
* An endoscopy documenting the presence of inflammation and absence of stage 4 polyps
* Ability to comply with the study requirements including the ability to administer a nasal lavage twice daily for 4 months
* Females of childbearing potential must use adequate birth control methods and not plan to get pregnant during the course of the study.
* Ability to read or speak English
Exclusion Criteria
* Is an immunosuppressed patient or is receiving disease modifying agents
* Has an acute upper or lower respiratory illness
* Has an acute exacerbation of chronic sinusitis within 1 month prior to randomization
* Has used systemic antibiotic therapy for reasons other than acute sinusitis within 3 weeks prior to randomization
* Has used any antibiotic therapy for acute complication of chronic sinusitis within 1 month prior to randomization
* Has orbital or central nervous system complications
* Has acute asthma at study initiation
* Began using nasal corticosteroids or had a dosage change within 3 months prior to randomization
* Has taken a dose of oral or intravenous steroids to treat any condition other than asthma within 1 month prior to randomization
* Has used any systemic antifungal therapy within 3 months prior to randomization
* Has used intranasal antifungal therapy for chronic sinusitis within 3 months prior to randomization
* Currently has a clinically significant deviated nasal septum that has not been remedied by surgery
* Has an anatomical abnormality which would significantly obstruct the nasal passages
* Has cystic fibrosis
* Is pregnant
* Has stage 4 polyposis
* Has any significant medical condition that in a doctor's opinion could affect the patient's participation in the trial
* Has used any investigational product within 1 month of study initiation
* 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
18 Years
85 Years
ALL
No
Sponsors
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Accentia Biopharmaceuticals
INDUSTRY
Responsible Party
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Accentia Biopharmaceuticals
Principal Investigators
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Angelos M Stergiou, MD
Role: STUDY_DIRECTOR
Accentia Biopharmaceuticals
Locations
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Parkway Medical Center
Birmingham, Alabama, United States
Alabama ENT Associates
Birmingham, Alabama, United States
Clinical Research Advantage
Gilbert, Arizona, United States
NEA Clinic
Jonesboro, Arkansas, United States
Kern Allergy Medical Clinic
Bakersfield, California, United States
SARC Research Center
Fresno, California, United States
California Allergy & Asthma Medical Group, Inc.
Los Angeles, California, United States
CHOC PSF, AMC, Division of Allergy, Asthma & Immunology
Orange, California, United States
Integrated Research Group Inc.
Riverside, California, United States
Allergy Medical Group of the North Area
Roseville, California, United States
Sacramento ENT
Sacramento, California, United States
Allergy & Asthma Clinical Research, Inc.
Walnut Creek, California, United States
Pravin K. Muniyappa, MD, Inc.
West Hills, California, United States
First Allergy & Clinical Research Center
Centennial, Colorado, United States
Colorado Otolaryngology Associates, PC
Colorado Springs, Colorado, United States
Connecticut Sinus Center
Bridgeport, Connecticut, United States
Bay Front Medical Center
St. Petersburg, Florida, United States
Allergy Center at Brookstone
Columbus, Georgia, United States
Allergy & Asthma Care Center
Gainesville, Georgia, United States
Northeast Georgia Research Center
Gainesville, Georgia, United States
Northwest ENT Associates
Marietta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Chest Medicine Consultants
Chicago, Illinois, United States
Asthma And Allergy Center Of Chicago
River Forest, Illinois, United States
South Bend Clinic
South Bend, Indiana, United States
Kansas City Allergy & Asthma
Overland Park, Kansas, United States
Commonwealth ENT, Head and Neck Center
Louisville, Kentucky, United States
Paul A. Shapero, MD
Bangor, Maine, United States
Institute of Allergy & Asthma
Wheaton, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Hurley Medical Center
Flint, Michigan, United States
Grand Traverse Allergy
Traverse City, Michigan, United States
Clinical Research Institute
Plymouth, Minnesota, United States
Jefferson City Medical Group
Jefferson City, Missouri, United States
St. Louis University
St Louis, Missouri, United States
Midwest Clinical Research, LLC
St Louis, Missouri, United States
Allergy & Asthma Consultants of Montana
Bozeman, Montana, United States
Central Jersey Health Care
Elizabeth, New Jersey, United States
David Sherris, M.D.
Buffalo, New York, United States
Health Sciences Research Center
Ithaca, New York, United States
Wellington Tichenor, MD
New York, New York, United States
DiGiovanna Family Care Center
North Massapequa, New York, United States
AAIR Research Center
Rochester, New York, United States
Center for Allergy & Asthma of Bronx & Westchester
The Bronx, New York, United States
Allergy Partners of Western North Carolina
Asheville, North Carolina, United States
Charlotte Eye, Ear, Nose & Throat Associates, P.A.
Charlotte, North Carolina, United States
Dr. Ann Bogard Private Practice
Winston-Salem, North Carolina, United States
Odyssey Research
Bismarck, North Dakota, United States
Center for Specialty Care
Fargo, North Dakota, United States
Hightop Medical Research Center
Cincinnati, Ohio, United States
Optimed Research
Columbus, Ohio, United States
Toledo Center for Clinical Research
Sylvania, Ohio, United States
COR Clinical Research
Oklahoma City, Oklahoma, United States
Allergy and Asthma Research of NJ, Inc.
Philadelphia, Pennsylvania, United States
ADAC Research
Greenville, South Carolina, United States
Sterling ENT / Carolina Research
Orangeburg, South Carolina, United States
The Asthma Institute, PLLC
Chattanooga, Tennessee, United States
Jackson Clinic
Jackson, Tennessee, United States
Vanderbilt University ASAP Research
Nashville, Tennessee, United States
Texas Medical and Surgical Associates
Dallas, Texas, United States
University Of North Texas Health Science Center
Fort Worth, Texas, United States
Allergy & Asthma Associates
Houston, Texas, United States
San Antonio Ear, Nose & Throat Research
San Antonio, Texas, United States
Live Oak Allergy & Asthma Clinic
San Antonio, Texas, United States
King's Daughters Clinic
Temple, Texas, United States
Virginia Adult & Pediatric Allergy & Asthma, P.C.
Richmond, Virginia, United States
Liberty Research Center
Tacoma, Washington, United States
Monroe Medical Foundation
Monroe, Wisconsin, United States
Countries
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Other Identifiers
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ACC-05-01
Identifier Type: -
Identifier Source: org_study_id