Amphotericin B Suspension in Refractory Chronic Sinusitis

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study of Intranasal Amphotericin B Suspension in Patients With Refractory, Postsurgical Chronic Sinusitis (CS)

Conditions
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Chronic Sinusitis

Intervention / Treatment
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* Drug: SinuNase


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amphotericin B<br> | Drug: SinuNase<br>* Lavage<br>* Other names: Amphotericin B Suspension;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Sinusitis, Chronic Rhinosinusitis