This clinical trial will evaluate the safety, tolerability and effectiveness of GLS-1200 nasal spray in addition to the standard of care after endoscopic sinus surgery in people with chronic sinusitis.
Subjects will be assigned to treatment via nasal spray with either GLS-1200 or placebo in blinded manner in a 2:1 ratio. Treatment will commence 1 week post-operatively and continue for 7 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
99
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Safety measures: treatment emergent adverse events by group will be summarized as frequencies by severity and relationship to treatment
Time frame: Post-op through week 16 post-FESS
Assess the incidence of post-operative acute rhinosinusitis relative to treatment assignment
Time frame: Post-op through week 16 post-FESS
Assess week 16 post-FESS Sino-Nasal Outcome Test-22 (SNOT-22) group scores change from baseline relative to treatment assignment
Time frame: Week 16 post-FESS
Assess antibiotic usage relative to treatment assignment
Time frame: 1 week post-op through week 16
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