Chronic Sinusitis
Conditions
Keywords
Chronic Sinusitis, Chronic Rhinosinusitis
Brief 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.
Interventions
DRUGSinuNase
Lavage
Sponsors
Accentia Biopharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed