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Amphotericin B Suspension in Refractory Chronic Sinusitis

Primary Purpose

Chronic Sinusitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SinuNase
Sponsored by
Accentia Biopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinusitis focused on measuring Chronic Sinusitis, Chronic Rhinosinusitis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Parkway Medical Center
  • Alabama ENT Associates
  • Clinical Research Advantage
  • NEA Clinic
  • Kern Allergy Medical Clinic
  • SARC Research Center
  • California Allergy & Asthma Medical Group, Inc.
  • CHOC PSF, AMC, Division of Allergy, Asthma & Immunology
  • Integrated Research Group Inc.
  • Allergy Medical Group of the North Area
  • Sacramento ENT
  • Allergy & Asthma Clinical Research, Inc.
  • Pravin K. Muniyappa, MD, Inc.
  • First Allergy & Clinical Research Center
  • Colorado Otolaryngology Associates, PC
  • Connecticut Sinus Center
  • Bay Front Medical Center
  • Allergy Center at Brookstone
  • Allergy & Asthma Care Center
  • Northeast Georgia Research Center
  • Northwest ENT Associates
  • Rush University Medical Center
  • Chest Medicine Consultants
  • Asthma And Allergy Center Of Chicago
  • South Bend Clinic
  • Kansas City Allergy & Asthma
  • Commonwealth ENT, Head and Neck Center
  • Paul A. Shapero, MD
  • Institute of Allergy & Asthma
  • Massachusetts General Hospital
  • Hurley Medical Center
  • Grand Traverse Allergy
  • Clinical Research Institute
  • Jefferson City Medical Group
  • St. Louis University
  • Midwest Clinical Research, LLC
  • Allergy & Asthma Consultants of Montana
  • Central Jersey Health Care
  • Center for Allergy & Asthma of Bronx & Westchester
  • David Sherris, M.D.
  • Health Sciences Research Center
  • DiGiovanna Family Care Center
  • Wellington Tichenor, MD
  • AAIR Research Center
  • Allergy Partners of Western North Carolina
  • Charlotte Eye, Ear, Nose & Throat Associates, P.A.
  • Dr. Ann Bogard Private Practice
  • Odyssey Research
  • Center for Specialty Care
  • Hightop Medical Research Center
  • Optimed Research
  • Toledo Center for Clinical Research
  • COR Clinical Research
  • Allergy and Asthma Research of NJ, Inc.
  • ADAC Research
  • Sterling ENT / Carolina Research
  • The Asthma Institute, PLLC
  • Jackson Clinic
  • Vanderbilt University ASAP Research
  • Texas Medical and Surgical Associates
  • University Of North Texas Health Science Center
  • Allergy & Asthma Associates
  • San Antonio Ear, Nose & Throat Research
  • Live Oak Allergy & Asthma Clinic
  • King's Daughters Clinic
  • Virginia Adult & Pediatric Allergy & Asthma, P.C.
  • Liberty Research Center
  • Monroe Medical Foundation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Amphotericin B

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 19, 2007
Last Updated
November 29, 2007
Sponsor
Accentia Biopharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00425620
Brief Title
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

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Accentia Biopharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis
Keywords
Chronic Sinusitis, Chronic Rhinosinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amphotericin B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SinuNase
Other Intervention Name(s)
Amphotericin B Suspension
Intervention Description
Lavage
Primary Outcome Measure Information:
Title
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.
Time Frame
Four months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelos M Stergiou, MD
Organizational Affiliation
Accentia Biopharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Parkway Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States
Facility Name
Alabama ENT Associates
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Clinical Research Advantage
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
NEA Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Kern Allergy Medical Clinic
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
SARC Research Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
California Allergy & Asthma Medical Group, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
CHOC PSF, AMC, Division of Allergy, Asthma & Immunology
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Integrated Research Group Inc.
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Allergy Medical Group of the North Area
City
Roseville
State/Province
California
ZIP/Postal Code
95678
Country
United States
Facility Name
Sacramento ENT
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Allergy & Asthma Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Pravin K. Muniyappa, MD, Inc.
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
First Allergy & Clinical Research Center
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Colorado Otolaryngology Associates, PC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Connecticut Sinus Center
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Bay Front Medical Center
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Allergy Center at Brookstone
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Allergy & Asthma Care Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Northeast Georgia Research Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Northwest ENT Associates
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Chest Medicine Consultants
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Asthma And Allergy Center Of Chicago
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Kansas City Allergy & Asthma
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Commonwealth ENT, Head and Neck Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Paul A. Shapero, MD
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Institute of Allergy & Asthma
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Grand Traverse Allergy
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Clinical Research Institute
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Jefferson City Medical Group
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
St. Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Midwest Clinical Research, LLC
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Allergy & Asthma Consultants of Montana
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59718
Country
United States
Facility Name
Central Jersey Health Care
City
Elizabeth
State/Province
New Jersey
ZIP/Postal Code
07202
Country
United States
Facility Name
Center for Allergy & Asthma of Bronx & Westchester
City
Bronx
State/Province
New York
ZIP/Postal Code
10465
Country
United States
Facility Name
David Sherris, M.D.
City
Buffalo
State/Province
New York
ZIP/Postal Code
14216
Country
United States
Facility Name
Health Sciences Research Center
City
Ithaca
State/Province
New York
ZIP/Postal Code
14850
Country
United States
Facility Name
DiGiovanna Family Care Center
City
N. Massapequa
State/Province
New York
ZIP/Postal Code
11758
Country
United States
Facility Name
Wellington Tichenor, MD
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
AAIR Research Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Allergy Partners of Western North Carolina
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Charlotte Eye, Ear, Nose & Throat Associates, P.A.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Dr. Ann Bogard Private Practice
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103-4146
Country
United States
Facility Name
Odyssey Research
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Center for Specialty Care
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Hightop Medical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
Optimed Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Toledo Center for Clinical Research
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
COR Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Allergy and Asthma Research of NJ, Inc.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19115
Country
United States
Facility Name
ADAC Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Sterling ENT / Carolina Research
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118-4900
Country
United States
Facility Name
The Asthma Institute, PLLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Jackson Clinic
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
Vanderbilt University ASAP Research
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1424
Country
United States
Facility Name
Texas Medical and Surgical Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University Of North Texas Health Science Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107-2699
Country
United States
Facility Name
Allergy & Asthma Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
San Antonio Ear, Nose & Throat Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Live Oak Allergy & Asthma Clinic
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
King's Daughters Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76502
Country
United States
Facility Name
Virginia Adult & Pediatric Allergy & Asthma, P.C.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Liberty Research Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Monroe Medical Foundation
City
Monroe
State/Province
Wisconsin
ZIP/Postal Code
53566
Country
United States

12. IPD Sharing Statement

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Amphotericin B Suspension in Refractory Chronic Sinusitis

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