Amphotericin B Suspension in Refractory Chronic Sinusitis - Full Text View

Sponsor:	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

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)

Resource links provided by NLM:

MedlinePlus related topics: Sinusitis

Drug Information available for: Amphotericin B

U.S. FDA Resources

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

Sponsors and Collaborators

Accentia Biopharmaceuticals

Investigators

Study Director:

Angelos M Stergiou, MD

Accentia Biopharmaceuticals

More Information

No publications provided

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

Keywords provided by Accentia Biopharmaceuticals:

Chronic Sinusitis
Chronic Rhinosinusitis

Additional relevant MeSH terms:

Abelcet
Anti-Infective Agents
Amphotericin B
Antiprotozoal Agents
Disease Attributes
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Sinusitis
Liposomal amphotericin B
Pharmacologic Actions
Nose Diseases

Anti-Bacterial Agents
Antiparasitic Agents
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Antifungal Agents
Therapeutic Uses
Antibiotics, Antifungal
Chronic Disease
Amebicides

ClinicalTrials.gov processed this record on February 08, 2010