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Amphotericin B Suspension in Refractory Chronic Sinusitis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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)

NCT00425620•Accentia Biopharmaceuticals

View on ClinicalTrials.gov

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

Age

18 - 85 years

Sex

ALL

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
+10 more criteria

Locations (68)

Parkway Medical Center

Birmingham, Alabama, United States

Alabama ENT Associates

Birmingham, Alabama, United States

Clinical Research Advantage

Gilbert, Arizona, United States

NEA Clinic

Jonesboro, Arkansas, United States

Kern Allergy Medical Clinic

Bakersfield, California, United States

SARC Research Center

Fresno, California, United States

California Allergy & Asthma Medical Group, Inc.

Los Angeles, California, United States

CHOC PSF, AMC, Division of Allergy, Asthma & Immunology

Orange, California, United States

Integrated Research Group Inc.

Riverside, California, United States

Allergy Medical Group of the North Area

Roseville, California, United States

Key Dates

Start Date

December 1, 2006

Completion Date

October 1, 2007

Last Updated

November 30, 2007

Enrollment

300

ACTUAL participants

Conditions

Chronic Sinusitis

Interventions

SinuNase

DRUG

Balloon Sinus Dilation In Office or OR

NCT00939393

Chronic Sinusitis

View study

WITHDRAWNPHASE2/PHASE3

Pre-operative Steroids in CRSsP

NCT05095961

Chronic Sinus DiseaseChronic Sinusitis, Ethmoidal+3 more

View study

UNKNOWN

Post-radiotherapy Rhinosinusitis in Children

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 30, 2007Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Amphotericin B Suspension in Refractory Chronic Sinusitis

Inclusion Criteria

Exclusion Criteria

Balloon Sinus Dilation In Office or OR

Pre-operative Steroids in CRSsP

Post-radiotherapy Rhinosinusitis in Children

Nitric Oxide Releasing Sinus Irrigation (NOSi) to Treat Recalcitrant Chronic Rhinosinusitis (RCRS)

XprESS Maxillary Balloon Dilation Study

Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis