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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Alabama ENT Associates, Birmingham, Alabama 35244, United States
Parkway Medical Center, Birmingham, Alabama 35215, United States
Clinical Research Advantage, Gilbert, Arizona 85234, United States
NEA Clinic, Jonesboro, Arkansas 72401, United States
CHOC PSF, AMC, Division of Allergy, Asthma & Immunology, Orange, California 92868, United States
Allergy & Asthma Clinical Research, Inc., Walnut Creek, California 94598, United States
Kern Allergy Medical Clinic, Bakersfield, California 93301, United States
Sacramento ENT, Sacramento, California 95816, United States
California Allergy & Asthma Medical Group, Inc., Los Angeles, California 90025, United States
SARC Research Center, Fresno, California 93720, United States
Allergy Medical Group of the North Area, Roseville, California 95678, United States
Integrated Research Group Inc., Riverside, California 92506, United States
Pravin K. Muniyappa, MD, Inc., West Hills, California 91307, United States
Colorado Otolaryngology Associates, PC, Colorado Springs, Colorado 80909, United States
First Allergy & Clinical Research Center, Centennial, Colorado 80112, United States
Connecticut Sinus Center, Bridgeport, Connecticut 06606, United States
Bay Front Medical Center, St. Petersburg, Florida 33701, United States
Northeast Georgia Research Center, Gainesville, Georgia 30501, United States
Allergy & Asthma Care Center, Gainesville, Georgia 30501, United States
Allergy Center at Brookstone, Columbus, Georgia 31904, United States
Northwest ENT Associates, Marietta, Georgia 30060, United States
Rush University Medical Center, Chicago, Illinois 60612, United States
Asthma And Allergy Center Of Chicago, River Forest, Illinois 60305, United States
Chest Medicine Consultants, Chicago, Illinois 60657, United States
South Bend Clinic, South Bend, Indiana 46617, United States
Kansas City Allergy & Asthma, Overland Park, Kansas 66210, United States
Commonwealth ENT, Head and Neck Center, Louisville, Kentucky 40207, United States
Paul A. Shapero, MD, Bangor, Maine 04401, United States
Institute of Allergy & Asthma, Wheaton, Maryland 20902, United States
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Hurley Medical Center, Flint, Michigan 48503, United States
Grand Traverse Allergy, Traverse City, Michigan 49684, United States
Clinical Research Institute, Plymouth, Minnesota 55441, United States
Midwest Clinical Research, LLC, St. Louis, Missouri 63141, United States
Jefferson City Medical Group, Jefferson City, Missouri 65109, United States
St. Louis University, St. Louis, Missouri 63110, United States
Allergy & Asthma Consultants of Montana, Bozeman, Montana 59718, United States
Central Jersey Health Care, Elizabeth, New Jersey 07202, United States
Center for Allergy & Asthma of Bronx & Westchester, Bronx, New York 10465, United States
AAIR Research Center, Rochester, New York 14618, United States
DiGiovanna Family Care Center, N. Massapequa, New York 11758, United States
Health Sciences Research Center, Ithaca, New York 14850, United States
Wellington Tichenor, MD, New York, New York 10021, United States
David Sherris, M.D., Buffalo, New York 14216, United States
Allergy Partners of Western North Carolina, Asheville, North Carolina 28801, United States
Charlotte Eye, Ear, Nose & Throat Associates, P.A., Charlotte, North Carolina 28210, United States
Dr. Ann Bogard Private Practice, Winston Salem, North Carolina 27103-4146, United States
Center for Specialty Care, Fargo, North Dakota 58104, United States
Odyssey Research, Bismarck, North Dakota 58501, United States
Toledo Center for Clinical Research, Sylvania, Ohio 43560, United States
Hightop Medical Research Center, Cincinnati, Ohio 45224, United States
Optimed Research, Columbus, Ohio 43235, United States
COR Clinical Research, Oklahoma City, Oklahoma 73103, United States
Allergy and Asthma Research of NJ, Inc., Philadelphia, Pennsylvania 19115, United States
ADAC Research, Greenville, South Carolina 29607, United States
Sterling ENT / Carolina Research, Orangeburg, South Carolina 29118-4900, United States
The Asthma Institute, PLLC, Chattanooga, Tennessee 37421, United States
Vanderbilt University ASAP Research, Nashville, Tennessee 37203-1424, United States
Jackson Clinic, Jackson, Tennessee 38301, United States
Live Oak Allergy & Asthma Clinic, San Antonio, Texas 78233, United States
San Antonio Ear, Nose & Throat Research, San Antonio, Texas 78229, United States
Allergy & Asthma Associates, Houston, Texas 77054, United States
Texas Medical and Surgical Associates, Dallas, Texas 75231, United States
University Of North Texas Health Science Center, Fort Worth, Texas 76107-2699, United States
King's Daughters Clinic, Temple, Texas 76502, United States
Virginia Adult & Pediatric Allergy & Asthma, P.C., Richmond, Virginia 23229, United States
Liberty Research Center, Tacoma, Washington 98405, United States
Monroe Medical Foundation, Monroe, Wisconsin 53566, United States
