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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Sinusitis

Intervention / Treatment
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* Drug: SPRC-AB01


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: SPRC-AB01<br>* 90 mg/3 mL BID, 180 mg/3 mL bid, placebo<br>|
| Experimental: 2<br> | Drug: SPRC-AB01<br>* 90 mg/3 mL BID, 180 mg/3 mL bid, placebo<br>|
| Placebo Comparator: 3<br> | Drug: SPRC-AB01<br>* 90 mg/3 mL BID, 180 mg/3 mL bid, placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in TSSS during first week post-therapy |  | 86 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Sinusitis