Trial record 10 of 220 for:    sinusitis

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
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
Antifungal Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 16, 2014