GLS-1200 Topical Nasal Spray to Prevent Sinusitis After Endoscopic Sinus Surgery

Efficacy, Safety, and Tolerability of Adjuvant GLS-1200 Topical Nasal Spray in the Prevention of Acute Rhinosinusitis Following Functional Endoscopic Sinus Surgery (FESS)

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.

Inclusion Criteria:

• Age 18 years or older;
• Able to provide informed consent
• Able and willing to comply with study procedures
• Elective FESS
• Able and willing to utilize an approved form of pregnancy prevention for women of child bearing potential

Exclusion Criteria:

• Pregnancy or documentation of pregnancy by pre-operative pregnancy test
• History of primary ciliary dyskinesia
• Known allergy to quinine, quinidine or mefloquine
• Know latex allergy
• History of hematologic malignancy
• History of bone marrow transplantation
• Current or planned chemotherapy treatment for hematologic or solid tumor during study period
• FESS performed non-electively and /or in preparation for decontamination of the sinuses related to cystic fibrosis or in preparation for chemotherapy, solid organ transplantation, or bone marrow transplantation