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.
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Clinical Research Consultants, Hoover, Alabama 35216, United States
NEA Clinic, Jonesboro, Arkansas 72401, United States
Central California Clinical Research, Fresno, California 93720, United States
Allergy Research Foundation, Inc, Los Angeles, California 90025, United States
Children's Hospital of Orange County, Orange, California 92868, United States
Allergy Medical Group of the North Area Inc, Roseville, California 95678, United States
Sacramento Ear, Nose & Throat, Sacramento, California 95815, United States
Allergy & Asthma Medical Group and Research Center, San Diego, California 92123, United States
1st Allergy & Clinical Research Center, Centennial, Colorado 80112, United States
Colorado Otolaryngology Associates, Colorado Springs, Colorado 80909, United States
The Connecticut Sinus Center, Bridgeport, Connecticut 06606, United States
Clinical Trials Management LLC, Boca Raton, Florida 33487, United States
Allergy & Asthma Center / South Florida ENT, Ft. Lauderdale, Florida 33334, United States
Clinical Research of West Florida, Tampa, Florida 33603, United States
Nasal Sinus and Allergy Institute, Alpharetta, Georgia 30004, United States
Northeast Georgia Research Center, Gainsville, Georgia 30501, United States
Northside Ear, Nose & Throat, Roswell, Georgia 30076, United States
Commonwealth Ear, Nose & Throat, Louisville, Kentucky 40207, United States
Calvert Internal Medicine Group, Prince Frederick, Maryland 20678, United States
Massachusetts General Hospital - Allergy Clinical Research, Boston, Massachusetts 02114, United States
Henry Ford Health System, Detroit, Michigan 48202, United States
Clinical Research Institute, Plymouth, Minnesota 55441, United States
Allergy & Sinus Center, Greenwood, Mississippi 38930, United States
Clinical Research Group of Montana, Bozeman, Montana 59718, United States
Shah Eye Ear Nose & Throat, Lawrenceville, New Jersey 08648, United States
ENT Care, Somerville, New Jersey 08876, United States
Center for Allergy and Asthma of Bronx and Westchester, Bronx, New York 10465, United States
Weill Medical College-Department of Otorhinolaryngology, New York, New York 10021, United States
University of Rochester-Otolaryngology Associates, Rochester, New York 14618, United States
Charlotte Eye, Ear, Nose & Throat Associates, Charlotte, North Carolina 28210, United States
Wilmington Health Associates, Wilmington, North Carolina 28405, United States
Cleveland Clinic - Head & Neck Institute, Cleveland, Ohio 44195, United States
Toledo Center for Clinical Research, Sylvania, Ohio 43560, United States
University of Pittsburgh - The Eye and Ear Institute, Pittsburgh, Pennsylvania 15213, United States
ADAC Research PA, Greenville, South Carolina 29607, United States
The Jackson Clinic, Jackson, Tennessee 38301, United States
The Allergy, Asthma & Sinus Center, Knoxville, Tennessee 37909, United States
Ear, Nose & Throat Associates of Corpus Christi / Research, Corpus Christi, Texas 78411, United States
Allergy and Asthma Associates, Houston, Texas 77054, United States
Research Across America, Plano, Texas 75093, United States
San Antonio Ear, Nose and Throat Research, San Antonio, Texas 78229, United States
Marshfield Clinic, Marshfield, Wisconsin 54449, United States
Marshfield Clinic - Weston Center, Weston, Wisconsin 54476, United States