Amphotericin B Suspension in Refractory Chronic Sinusitis
- Conditions
- Chronic Sinusitis
- Interventions
- Drug: SinuNase
- Registration Number
- NCT00425620
- Lead Sponsor
- Accentia Biopharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Amphotericin B SinuNase -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (68)
Parkway Medical Center
🇺🇸Birmingham, Alabama, United States
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
Scroll for more (58 remaining)Parkway Medical Center🇺🇸Birmingham, Alabama, United States