Amphotericin B Suspension in Refractory Chronic Sinusitis
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study of Intranasal Amphotericin B Suspension in Patients With Refractory, Postsurgical Chronic Sinusitis (CS)
1 other identifier
interventional
300
1 country
68
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2006
Shorter than P25 for phase_3
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 19, 2007
CompletedFirst Posted
Study publicly available on registry
January 23, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedNovember 30, 2007
November 1, 2007
January 19, 2007
November 29, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Amphotericin B
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (68)
Parkway Medical Center
Birmingham, Alabama, 35215, United States
Alabama ENT Associates
Birmingham, Alabama, 35244, United States
Clinical Research Advantage
Gilbert, Arizona, 85234, United States
NEA Clinic
Jonesboro, Arkansas, 72401, United States
Kern Allergy Medical Clinic
Bakersfield, California, 93301, United States
SARC Research Center
Fresno, California, 93720, United States
California Allergy & Asthma Medical Group, Inc.
Los Angeles, California, 90025, United States
CHOC PSF, AMC, Division of Allergy, Asthma & Immunology
Orange, California, 92868, United States
Integrated Research Group Inc.
Riverside, California, 92506, United States
Allergy Medical Group of the North Area
Roseville, California, 95678, United States
Sacramento ENT
Sacramento, California, 95816, United States
Allergy & Asthma Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Pravin K. Muniyappa, MD, Inc.
West Hills, California, 91307, United States
First Allergy & Clinical Research Center
Centennial, Colorado, 80112, United States
Colorado Otolaryngology Associates, PC
Colorado Springs, Colorado, 80909, United States
Connecticut Sinus Center
Bridgeport, Connecticut, 06606, United States
Bay Front Medical Center
St. Petersburg, Florida, 33701, United States
Allergy Center at Brookstone
Columbus, Georgia, 31904, United States
Allergy & Asthma Care Center
Gainesville, Georgia, 30501, United States
Northeast Georgia Research Center
Gainesville, Georgia, 30501, United States
Northwest ENT Associates
Marietta, Georgia, 30060, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Chest Medicine Consultants
Chicago, Illinois, 60657, United States
Asthma And Allergy Center Of Chicago
River Forest, Illinois, 60305, 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
Jefferson City Medical Group
Jefferson City, Missouri, 65109, United States
St. Louis University
St Louis, Missouri, 63110, United States
Midwest Clinical Research, LLC
St Louis, Missouri, 63141, United States
Allergy & Asthma Consultants of Montana
Bozeman, Montana, 59718, United States
Central Jersey Health Care
Elizabeth, New Jersey, 07202, United States
David Sherris, M.D.
Buffalo, New York, 14216, United States
Health Sciences Research Center
Ithaca, New York, 14850, United States
Wellington Tichenor, MD
New York, New York, 10021, United States
DiGiovanna Family Care Center
North Massapequa, New York, 11758, United States
AAIR Research Center
Rochester, New York, 14618, United States
Center for Allergy & Asthma of Bronx & Westchester
The Bronx, New York, 10465, 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
Odyssey Research
Bismarck, North Dakota, 58501, United States
Center for Specialty Care
Fargo, North Dakota, 58104, United States
Hightop Medical Research Center
Cincinnati, Ohio, 45224, United States
Optimed Research
Columbus, Ohio, 43235, United States
Toledo Center for Clinical Research
Sylvania, Ohio, 43560, 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
Jackson Clinic
Jackson, Tennessee, 38301, United States
Vanderbilt University ASAP Research
Nashville, Tennessee, 37203-1424, 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
Allergy & Asthma Associates
Houston, Texas, 77054, United States
San Antonio Ear, Nose & Throat Research
San Antonio, Texas, 78229, United States
Live Oak Allergy & Asthma Clinic
San Antonio, Texas, 78233, 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
Study Officials
- STUDY DIRECTOR
Angelos M Stergiou, MD
Accentia Biopharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 19, 2007
First Posted
January 23, 2007
Study Start
December 1, 2006
Study Completion
October 1, 2007
Last Updated
November 30, 2007
Record last verified: 2007-11