Amphotericin B Suspension in Refractory Chronic Sinusitis

This study has been completed.
Sponsor:
Information provided by:
Accentia Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00425620
First received: January 19, 2007
Last updated: November 29, 2007
Last verified: November 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


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
Experimental: Amphotericin B Drug: SinuNase
Lavage
Other Name: Amphotericin B Suspension

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 68 Study Locations
Sponsors and Collaborators
Accentia Biopharmaceuticals
Investigators
Study Director: Angelos M Stergiou, MD Accentia Biopharmaceuticals
  More Information

No publications provided

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

Keywords provided by Accentia Biopharmaceuticals:
Chronic Sinusitis
Chronic Rhinosinusitis

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Amphotericin B
Liposomal amphotericin B
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 18, 2014