Status:
COMPLETED
Amphotericin B Suspension in Refractory Chronic Sinusitis
Lead Sponsor:
Accentia Biopharmaceuticals
Conditions:
Chronic Sinusitis
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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 tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00425620
Start Date
December 1 2006
End Date
October 1 2007
Last Update
November 30 2007
Active Locations (68)
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1
Parkway Medical Center
Birmingham, Alabama, United States, 35215
2
Alabama ENT Associates
Birmingham, Alabama, United States, 35244
3
Clinical Research Advantage
Gilbert, Arizona, United States, 85234
4
NEA Clinic
Jonesboro, Arkansas, United States, 72401