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Amphotericin B Suspension in Refractory Chronic Sinusitis

This study has been completed.

Sponsored by: Accentia Biopharmaceuticals
Information provided by: Accentia Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00425620
  Purpose

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.


Condition Intervention Phase
Chronic Sinusitis
Drug: SinuNase
Phase III

MedlinePlus related topics:   Sinusitis   

ChemIDplus related topics:   Amphotericin B   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study of Intranasal Amphotericin B Suspension in Patients With Refractory, Postsurgical Chronic Sinusitis (CS)

Further study details as provided by Accentia Biopharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment:   300
Study Start Date:   December 2006
Study Completion Date:   October 2007

Arms Assigned Interventions
Amphotericin B: Experimental Drug: SinuNase
Lavage

  Eligibility
Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425620

Show 68 study locations  Show 68 Study Locations

Sponsors and Collaborators
Accentia Biopharmaceuticals

Investigators
Study Director:     Angelos M Stergiou, MD     Accentia Biopharmaceuticals    
  More Information


Responsible Party:   Accentia Biopharmaceuticals ( Ben McOmber, MPH )
Study ID Numbers:   ACC-05-01
First Received:   January 19, 2007
Last Updated:   November 29, 2007
ClinicalTrials.gov Identifier:   NCT00425620
Health Authority:   United States: Food and Drug Administration

Keywords provided by Accentia Biopharmaceuticals:
Chronic Sinusitis  
Chronic Rhinosinusitis  

Study placed in the following topic categories:
Abelcet
Amphotericin B
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Clotrimazole
Miconazole
AmBisome
Tioconazole
Chronic Disease
Sinusitis

Additional relevant MeSH terms:
Anti-Infective Agents
Disease Attributes
Antiprotozoal Agents
Paranasal Sinus Diseases
Nose Diseases
Pharmacologic Actions
Anti-Bacterial Agents
Antiparasitic Agents
Pathologic Processes
Therapeutic Uses
Antifungal Agents
Antibiotics, Antifungal
Amebicides

ClinicalTrials.gov processed this record on October 03, 2008




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