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Amphotericin B Suspension in Refractory Chronic Sinusitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00425620
First Posted: January 23, 2007
Last Update Posted: November 30, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Accentia Biopharmaceuticals
January 19, 2007
January 23, 2007
November 30, 2007
December 2006
Not Provided
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. [ Time Frame: Four months ]
Not Provided
Complete list of historical versions of study NCT00425620 on ClinicalTrials.gov Archive Site
Not Provided
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Amphotericin B Suspension in Refractory Chronic Sinusitis
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study of Intranasal Amphotericin B Suspension in Patients With Refractory, Postsurgical Chronic Sinusitis (CS)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Sinusitis
Drug: SinuNase
Lavage
Other Name: Amphotericin B Suspension
Experimental: Amphotericin B
Intervention: Drug: SinuNase
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
October 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00425620
ACC-05-01
No
Not Provided
Not Provided
Ben McOmber, MPH, Accentia Biopharmaceuticals
Accentia Biopharmaceuticals
Not Provided
Study Director: Angelos M Stergiou, MD Accentia Biopharmaceuticals
Accentia Biopharmaceuticals
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP