Amphotericin B Suspension in Refractory Chronic Sinusitis
- Conditions
- Chronic Sinusitis
- Interventions
- Drug: SinuNase
- Registration Number
- NCT00425620
- Lead Sponsor
- Accentia Biopharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- Has a diagnosis of refractory, postsurgical chronic sinusitis
- 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
- Has a hypersensitivity to Amphotericin B or the compounds of any study medications
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Amphotericin B SinuNase -
- Primary Outcome Measures
Name Time Method 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. Four months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (68)
Clinical Research Advantage
🇺🇸Gilbert, Arizona, United States
NEA Clinic
🇺🇸Jonesboro, Arkansas, United States
Kern Allergy Medical Clinic
🇺🇸Bakersfield, California, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
Optimed Research
🇺🇸Columbus, Ohio, United States
California Allergy & Asthma Medical Group, Inc.
🇺🇸Los Angeles, California, United States
Connecticut Sinus Center
🇺🇸Bridgeport, Connecticut, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Allergy Partners of Western North Carolina
🇺🇸Asheville, North Carolina, United States
Odyssey Research
🇺🇸Bismarck, North Dakota, United States
The Asthma Institute, PLLC
🇺🇸Chattanooga, Tennessee, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, 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
COR Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
First Allergy & Clinical Research Center
🇺🇸Centennial, Colorado, United States
Colorado Otolaryngology Associates, PC
🇺🇸Colorado Springs, Colorado, United States
CHOC PSF, AMC, Division of Allergy, Asthma & Immunology
🇺🇸Orange, California, United States
SARC Research Center
🇺🇸Fresno, California, United States
Bay Front Medical Center
🇺🇸St. Petersburg, Florida, United States
Chest Medicine Consultants
🇺🇸Chicago, Illinois, United States
Allergy Center at Brookstone
🇺🇸Columbus, Georgia, United States
Clinical Research Institute
🇺🇸Plymouth, Minnesota, United States
Kansas City Allergy & Asthma
🇺🇸Overland Park, Kansas, United States
Institute of Allergy & Asthma
🇺🇸Wheaton, Maryland, United States
Paul A. Shapero, MD
🇺🇸Bangor, Maine, United States
Jefferson City Medical Group
🇺🇸Jefferson City, Missouri, United States
Central Jersey Health Care
🇺🇸Elizabeth, New Jersey, United States
David Sherris, M.D.
🇺🇸Buffalo, New York, United States
Vanderbilt University ASAP Research
🇺🇸Nashville, Tennessee, United States
Toledo Center for Clinical Research
🇺🇸Sylvania, Ohio, United States
Texas Medical and Surgical Associates
🇺🇸Dallas, Texas, United States
University Of North Texas Health Science Center
🇺🇸Fort Worth, Texas, United States
Virginia Adult & Pediatric Allergy & Asthma, P.C.
🇺🇸Richmond, Virginia, United States
King's Daughters Clinic
🇺🇸Temple, Texas, United States
Liberty Research Center
🇺🇸Tacoma, Washington, United States
Monroe Medical Foundation
🇺🇸Monroe, Wisconsin, United States
St. Louis University
🇺🇸St. Louis, Missouri, United States
Midwest Clinical Research, LLC
🇺🇸St. Louis, Missouri, United States
Integrated Research Group Inc.
🇺🇸Riverside, California, United States
Pravin K. Muniyappa, MD, Inc.
🇺🇸West Hills, California, United States
Allergy Medical Group of the North Area
🇺🇸Roseville, California, United States
Allergy & Asthma Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Northwest ENT Associates
🇺🇸Marietta, Georgia, United States
Allergy & Asthma Care Center
🇺🇸Gainesville, Georgia, United States
Northeast Georgia Research Center
🇺🇸Gainesville, Georgia, United States
Wellington Tichenor, MD
🇺🇸New York, New York, United States
Center for Allergy & Asthma of Bronx & Westchester
🇺🇸Bronx, New York, United States
DiGiovanna Family Care Center
🇺🇸N. Massapequa, New York, United States
Health Sciences Research Center
🇺🇸Ithaca, New York, United States
Center for Specialty Care
🇺🇸Fargo, North Dakota, United States
Dr. Ann Bogard Private Practice
🇺🇸Winston Salem, North Carolina, United States
Sterling ENT / Carolina Research
🇺🇸Orangeburg, South Carolina, United States
AAIR Research Center
🇺🇸Rochester, New York, United States
Charlotte Eye, Ear, Nose & Throat Associates, P.A.
🇺🇸Charlotte, North Carolina, United States
Allergy and Asthma Research of NJ, Inc.
🇺🇸Philadelphia, Pennsylvania, United States
Hightop Medical Research Center
🇺🇸Cincinnati, Ohio, United States
Parkway Medical Center
🇺🇸Birmingham, Alabama, United States
Alabama ENT Associates
🇺🇸Birmingham, Alabama, United States
Sacramento ENT
🇺🇸Sacramento, California, United States
Commonwealth ENT, Head and Neck Center
🇺🇸Louisville, Kentucky, United States
Grand Traverse Allergy
🇺🇸Traverse City, Michigan, United States
ADAC Research
🇺🇸Greenville, South Carolina, United States
Jackson Clinic
🇺🇸Jackson, Tennessee, United States
Allergy & Asthma Consultants of Montana
🇺🇸Bozeman, Montana, United States
Asthma And Allergy Center Of Chicago
🇺🇸River Forest, Illinois, United States