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)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Sinusitis
• Intervention / Treatment: Drug: SinuNase

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amphotericin B	Drug: SinuNase; Lavage; Other Names: Amphotericin B Suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Accentia Biopharmaceuticals
• Investigators: Study Director: Angelos M Stergiou, MD, Accentia Biopharmaceuticals

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: January 19, 2007
• First Submitted That Met QC Criteria: January 22, 2007
• First Posted (Estimate): January 23, 2007

Study Record Updates

• Last Update Posted (Estimate): November 30, 2007
• Last Update Submitted That Met QC Criteria: November 29, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Keywords: Chronic Rhinosinusitis; Chronic Sinusitis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Chronic Disease; Anti-Infective Agents; Anti-Bacterial Agents; Antifungal Agents; Antiprotozoal Agents; Antiparasitic Agents; Amebicides; Amphotericin B
• Other Study ID Numbers: ACC-05-01