Amphotericin B Suspension in Refractory Chronic Sinusitis

Accentia Biopharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Chronic Sinusitis

Treatments

Drug: SinuNase

Study type

Interventional

Funder types

Industry

Identifiers

NCT00425620

ACC-05-01

Details and patient eligibility

About

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.

Enrollment

300 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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