Clinical trial NCT00447837: Evaluating SPRC-AB01 in Post-Surgical Subjects With Chronic Sinusitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Sinusitis
Keywords: Chronic Sinusitis
Lead sponsor: Naryx Pharma
Sponsor class: INDUSTRY
First posted: 2007-03-15
Enrollment: 180
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in TSSS during first week post-therapy
timeFrame: 86 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Clinical Research Consultants
state: Alabama
city: Jonesboro
country: United States
facility: NEA Clinic
state: Arkansas
city: Fresno
country: United States
facility: Central California Clinical Research
state: California
city: Los Angeles
country: United States
facility: Allergy Research Foundation, Inc
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Roseville
country: United States
facility: Allergy Medical Group of the North Area Inc
state: California
city: Sacramento
country: United States
facility: Sacramento Ear, Nose & Throat
state: California
city: San Diego
country: United States
facility: Allergy & Asthma Medical Group and Research Center
state: California
city: Centennial
country: United States
facility: 1st Allergy & Clinical Research Center
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Otolaryngology Associates
state: Colorado
city: Bridgeport
country: United States
facility: The Connecticut Sinus Center
state: Connecticut
city: Boca Raton
country: United States
facility: Clinical Trials Management LLC
state: Florida
city: Ft. Lauderdale
country: United States
facility: Allergy & Asthma Center / South Florida ENT
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Alpharetta
country: United States
facility: Nasal Sinus and Allergy Institute
state: Georgia
city: Gainsville
country: United States
facility: Northeast Georgia Research Center
state: Georgia
city: Roswell
country: United States
facility: Northside Ear, Nose & Throat
state: Georgia
city: Louisville
country: United States
facility: Commonwealth Ear, Nose & Throat
state: Kentucky
city: Prince Frederick
country: United States
facility: Calvert Internal Medicine Group
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital - Allergy Clinical Research
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Plymouth
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Greenwood
country: United States
facility: Allergy & Sinus Center
state: Mississippi
city: Bozeman
country: United States
facility: Clinical Research Group of Montana
state: Montana
city: Lawrenceville
country: United States
facility: Shah Eye Ear Nose & Throat
state: New Jersey
city: Somerville
country: United States
facility: ENT Care
state: New Jersey
city: Bronx
country: United States
facility: Center for Allergy and Asthma of Bronx and Westchester
state: New York
city: New York
country: United States
facility: Weill Medical College-Department of Otorhinolaryngology
state: New York
city: Rochester
country: United States
facility: University of Rochester-Otolaryngology Associates
state: New York
city: Charlotte
country: United States
facility: Charlotte Eye, Ear, Nose & Throat Associates
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Health Associates
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic - Head & Neck Institute
state: Ohio
city: Sylvania
country: United States
facility: Toledo Center for Clinical Research
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh - The Eye and Ear Institute
state: Pennsylvania
city: Greenville
country: United States
facility: ADAC Research PA
state: South Carolina
city: Jackson
country: United States
facility: The Jackson Clinic
state: Tennessee
city: Knoxville
country: United States
facility: The Allergy, Asthma & Sinus Center
state: Tennessee
city: Corpus Christi
country: United States
facility: Ear, Nose & Throat Associates of Corpus Christi / Research
state: Texas
city: Houston
country: United States
facility: Allergy and Asthma Associates
state: Texas
city: Plano
country: United States
facility: Research Across America
state: Texas
city: San Antonio
country: United States
facility: San Antonio Ear, Nose and Throat Research
state: Texas
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Weston
country: United States
facility: Marshfield Clinic - Weston Center
state: Wisconsin
Study officials:
References: