Amphotericin B Suspension in Refractory Chronic Sinusitis

Completed · Phase 3

Conditions studied: Chronic Sinusitis

In brief

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.

Key facts

Study ID

NCT00425620

Run by

Accentia Biopharmaceuticals

People needed

300

Starts

2006-12-01

Expected to finish

2007-10-01

Last updated by the study team

2007-11-30

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Sacramento ENT — Sacramento, California, United States
• Allergy & Asthma Clinical Research, Inc. — Walnut Creek, California, United States
• Pravin K. Muniyappa, MD, Inc. — West Hills, California, United States
• First Allergy & Clinical Research Center — Centennial, Colorado, United States
• Colorado Otolaryngology Associates, PC — Colorado Springs, Colorado, United States
• Connecticut Sinus Center — Bridgeport, Connecticut, United States
• Bay Front Medical Center — St. Petersburg, Florida, United States
• Allergy Center at Brookstone — Columbus, Georgia, United States
• Allergy & Asthma Care Center — Gainesville, Georgia, United States
• Northeast Georgia Research Center — Gainesville, Georgia, United States
• Northwest ENT Associates — Marietta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Chest Medicine Consultants — Chicago, Illinois, United States
• Asthma And Allergy Center Of Chicago — River Forest, Illinois, United States
• South Bend Clinic — South Bend, Indiana, United States
• Parkway Medical Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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