Chronic Sinusitis
Conditions
Keywords
Chronic Sinusitis
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.
Interventions
DRUGSPRC-AB01
90 mg/3 mL BID, 180 mg/3 mL bid, placebo
Sponsors
Naryx Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in TSSS during first week post-therapy | 86 days |
Countries
United States
Outcome results
None listed