Amphotericin B Suspension in Refractory Chronic Sinusitis

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