Amphotericin B Suspension in Refractory Chronic Sinusitis

Chronic Sinusitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00425620
• Other study ID #: ACC-05-01
• Status: Completed
• Phase: Phase 3
• First received: January 19, 2007
• Last updated: November 29, 2007
• Start date: December 2006
• Est. completion date: October 2007

Study information

• Verified date: November 2007
• Source: Accentia Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Sinusitis
• Sinusitis

Intervention

Drug:
• SinuNase
Lavage

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Accentia Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes