Evaluating SPRC-AB01 in Post-Surgical Subjects With Chronic Sinusitis

Chronic Sinusitis Clinical Trial

Official title:

A Phase 2, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Study Evaluating the Safety and Efficacy of SPRC-AB01, Tobramycin Solution for Nasal Inhalation, in Post-Surgical Subjects With Chronic Sinusitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447837
• Other study ID #: SPRC-AB01-003
• Status: Completed
• Phase: Phase 2
• First received: March 13, 2007
• Last updated: March 13, 2008
• Start date: October 2006
• Est. completion date: January 2008

Study information

• Verified date: December 2007
• Source: Naryx Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to evaluate the safety and efficacy of SPRC-AB01 versus placebo for treatment of chronic sinusitis in subjects who have had sinus surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Outpatient subjects who have signed a written informed consent.

• A documented history of chronic sinusitis with clinical signs and symptoms suggestive of inflammation or infection for at least 90 consecutive days.

• A documented history of sinus surgery > 90 days.

• Nasal endoscopic exam documenting purulence (pus) from an open sinus cavity with mucosal swelling/edema.

• Women of childbearing potential must have a negative serum pregnancy test and must use adequate birth control throughout the study.

Exclusion Criteria:

• Pregnant females and females unwilling to use adequate birth control.

• Use of any investigational drug/device within 30 days of study screening.

• The following medications will require a certain washout period as determined by the protocol: systemic corticosteroids, mast cells and/or leukotriene inhibitors, anti-inflammatories, decongestants, antihistamines, non-steroidal anti-inflammatory (NSAID) or cyclooxygenase (COX)-2 inhibitors, antibiotics or antifungals.

• Presence of other infections which may require use of systemic antibiotics.

• Known allergy or hypersensitivity to aminoglycosides or other study drug formulation components.

• Recent hospitalization for any reason and/or major surgeries within 30 days of study screening.

• Major elective and/or nasal and/or sinus surgical procedures (including sinuplasty) within 90 days before or 90 days after study screening.

• Known history of neurological or muscular disorders.

• Diagnosis of an immunodeficiency disease.

• Previous diagnosis of cystic fibrosis, ciliary dyskinesias, Kartagener syndrome, empty nose syndrome, Wegener granulomatosis, Churg-Strauss syndrome, Samter syndrome, or sarcoidosis.

• Current or known history of tinnitus, vertigo, or significant sensorineural hearing loss.

• Recent history of alcohol or drug abuse.

• Inability to understand the nature, scope, and possible consequences of the study or study procedures, unless cared for by a legally authorized representative.

• Inability to adhere to the study requirements.

• Previous participation in any Naryx Pharma protocol.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Sinusitis
• Sinusitis

Intervention

Drug:
• SPRC-AB01
90 mg/3 mL BID, 180 mg/3 mL bid, placebo

Locations

Country	Name	City	State
United States	Nasal Sinus and Allergy Institute	Alpharetta	Georgia
United States	Clinical Trials Management LLC	Boca Raton	Florida
United States	Massachusetts General Hospital - Allergy Clinical Research	Boston	Massachusetts
United States	Clinical Research Group of Montana	Bozeman	Montana
United States	The Connecticut Sinus Center	Bridgeport	Connecticut
United States	Center for Allergy and Asthma of Bronx and Westchester	Bronx	New York
United States	1st Allergy & Clinical Research Center	Centennial	Colorado
United States	Charlotte Eye, Ear, Nose & Throat Associates	Charlotte	North Carolina
United States	Cleveland Clinic - Head & Neck Institute	Cleveland	Ohio
United States	Colorado Otolaryngology Associates	Colorado Springs	Colorado
United States	Ear, Nose & Throat Associates of Corpus Christi / Research	Corpus Christi	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Central California Clinical Research	Fresno	California
United States	Allergy & Asthma Center / South Florida ENT	Ft. Lauderdale	Florida
United States	Northeast Georgia Research Center	Gainsville	Georgia
United States	ADAC Research PA	Greenville	South Carolina
United States	Allergy & Sinus Center	Greenwood	Mississippi
United States	Clinical Research Consultants	Hoover	Alabama
United States	Allergy and Asthma Associates	Houston	Texas
United States	The Jackson Clinic	Jackson	Tennessee
United States	NEA Clinic	Jonesboro	Arkansas
United States	The Allergy, Asthma & Sinus Center	Knoxville	Tennessee
United States	Shah Eye Ear Nose & Throat	Lawrenceville	New Jersey
United States	Allergy Research Foundation, Inc	Los Angeles	California
United States	Commonwealth Ear, Nose & Throat	Louisville	Kentucky
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Weill Medical College-Department of Otorhinolaryngology	New York	New York
United States	Children's Hospital of Orange County	Orange	California
United States	University of Pittsburgh - The Eye and Ear Institute	Pittsburgh	Pennsylvania
United States	Research Across America	Plano	Texas
United States	Clinical Research Institute	Plymouth	Minnesota
United States	Calvert Internal Medicine Group	Prince Frederick	Maryland
United States	University of Rochester-Otolaryngology Associates	Rochester	New York
United States	Allergy Medical Group of the North Area Inc	Roseville	California
United States	Northside Ear, Nose & Throat	Roswell	Georgia
United States	Sacramento Ear, Nose & Throat	Sacramento	California
United States	San Antonio Ear, Nose and Throat Research	San Antonio	Texas
United States	Allergy & Asthma Medical Group and Research Center	San Diego	California
United States	ENT Care	Somerville	New Jersey
United States	Toledo Center for Clinical Research	Sylvania	Ohio
United States	Clinical Research of West Florida	Tampa	Florida
United States	Marshfield Clinic - Weston Center	Weston	Wisconsin
United States	Wilmington Health Associates	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Naryx Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in TSSS during first week post-therapy		86 days	No