Clinical trial NCT00425620: Amphotericin B Suspension in Refractory Chronic Sinusitis
Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study of Intranasal Amphotericin B Suspension in Patients With Refractory, Postsurgical Chronic Sinusitis (CS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Sinusitis
Keywords: Chronic Sinusitis
Chronic Rhinosinusitis
Lead sponsor: Accentia Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-01-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Parkway Medical Center
state: Alabama
city: Birmingham
country: United States
facility: Alabama ENT Associates
state: Alabama
city: Gilbert
country: United States
facility: Clinical Research Advantage
state: Arizona
city: Jonesboro
country: United States
facility: NEA Clinic
state: Arkansas
city: Bakersfield
country: United States
facility: Kern Allergy Medical Clinic
state: California
city: Fresno
country: United States
facility: SARC Research Center
state: California
city: Los Angeles
country: United States
facility: California Allergy & Asthma Medical Group, Inc.
state: California
city: Orange
country: United States
facility: CHOC PSF, AMC, Division of Allergy, Asthma & Immunology
state: California
city: Riverside
country: United States
facility: Integrated Research Group Inc.
state: California
city: Roseville
country: United States
facility: Allergy Medical Group of the North Area
state: California
city: Sacramento
country: United States
facility: Sacramento ENT
state: California
city: Walnut Creek
country: United States
facility: Allergy & Asthma Clinical Research, Inc.
state: California
city: West Hills
country: United States
facility: Pravin K. Muniyappa, MD, Inc.
state: California
city: Centennial
country: United States
facility: First Allergy & Clinical Research Center
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Otolaryngology Associates, PC
state: Colorado
city: Bridgeport
country: United States
facility: Connecticut Sinus Center
state: Connecticut
city: St. Petersburg
country: United States
facility: Bay Front Medical Center
state: Florida
city: Columbus
country: United States
facility: Allergy Center at Brookstone
state: Georgia
city: Gainesville
country: United States
facility: Allergy & Asthma Care Center
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Research Center
state: Georgia
city: Marietta
country: United States
facility: Northwest ENT Associates
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: Chest Medicine Consultants
state: Illinois
city: River Forest
country: United States
facility: Asthma And Allergy Center Of Chicago
state: Illinois
city: South Bend
country: United States
facility: South Bend Clinic
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Allergy & Asthma
state: Kansas
city: Louisville
country: United States
facility: Commonwealth ENT, Head and Neck Center
state: Kentucky
city: Bangor
country: United States
facility: Paul A. Shapero, MD
state: Maine
city: Wheaton
country: United States
facility: Institute of Allergy & Asthma
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Traverse City
country: United States
facility: Grand Traverse Allergy
state: Michigan
city: Plymouth
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Jefferson City
country: United States
facility: Jefferson City Medical Group
state: Missouri
city: St. Louis
country: United States
facility: St. Louis University
state: Missouri
city: St. Louis
country: United States
facility: Midwest Clinical Research, LLC
state: Missouri
city: Bozeman
country: United States
facility: Allergy & Asthma Consultants of Montana
state: Montana
city: Elizabeth
country: United States
facility: Central Jersey Health Care
state: New Jersey
city: Bronx
country: United States
facility: Center for Allergy & Asthma of Bronx & Westchester
state: New York
city: Buffalo
country: United States
facility: David Sherris, M.D.
state: New York
city: Ithaca
country: United States
facility: Health Sciences Research Center
state: New York
city: N. Massapequa
country: United States
facility: DiGiovanna Family Care Center
state: New York
city: New York
country: United States
facility: Wellington Tichenor, MD
state: New York
city: Rochester
country: United States
facility: AAIR Research Center
state: New York
city: Asheville
country: United States
facility: Allergy Partners of Western North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Eye, Ear, Nose & Throat Associates, P.A.
state: North Carolina
city: Winston Salem
country: United States
facility: Dr. Ann Bogard Private Practice
state: North Carolina
city: Bismarck
country: United States
facility: Odyssey Research
state: North Dakota
city: Fargo
country: United States
facility: Center for Specialty Care
state: North Dakota
city: Cincinnati
country: United States
facility: Hightop Medical Research Center
state: Ohio
city: Columbus
country: United States
facility: Optimed Research
state: Ohio
city: Sylvania
country: United States
facility: Toledo Center for Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: COR Clinical Research
state: Oklahoma
city: Philadelphia
country: United States
facility: Allergy and Asthma Research of NJ, Inc.
state: Pennsylvania
city: Greenville
country: United States
facility: ADAC Research
state: South Carolina
city: Orangeburg
country: United States
facility: Sterling ENT / Carolina Research
state: South Carolina
city: Chattanooga
country: United States
facility: The Asthma Institute, PLLC
state: Tennessee
city: Jackson
country: United States
facility: Jackson Clinic
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University ASAP Research
state: Tennessee
city: Dallas
country: United States
facility: Texas Medical and Surgical Associates
state: Texas
city: Fort Worth
country: United States
facility: University Of North Texas Health Science Center
state: Texas
city: Houston
country: United States
facility: Allergy & Asthma Associates
state: Texas
city: San Antonio
country: United States
facility: San Antonio Ear, Nose & Throat Research
state: Texas
city: San Antonio
country: United States
facility: Live Oak Allergy & Asthma Clinic
state: Texas
city: Temple
country: United States
facility: King's Daughters Clinic
state: Texas
city: Richmond
country: United States
facility: Virginia Adult & Pediatric Allergy & Asthma, P.C.
state: Virginia
city: Tacoma
country: United States
facility: Liberty Research Center
state: Washington
city: Monroe
country: United States
facility: Monroe Medical Foundation
state: Wisconsin
Study officials:
affiliation: Accentia Biopharmaceuticals
name: Angelos M Stergiou, MD
role: STUDY_DIRECTOR
References: