GLS-1200 Topical Nasal Spray to Prevent Sinusitis After Endoscopic Sinus Surgery
- Registration Number
- NCT04060316
- Lead Sponsor
- GeneOne Life Science, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 99
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GLS-1200 GLS-1200 3 ml of GLS-1200 (1 mg/ml in 0.9% saline) Sterile Saline Placebo 3 ml of 0.9% saline
- Primary Outcome Measures
Name Time Method Safety measures: treatment emergent adverse events by group will be summarized as frequencies by severity and relationship to treatment Post-op through week 16 post-FESS Assess the incidence of post-operative acute rhinosinusitis relative to treatment assignment Post-op through week 16 post-FESS
- Secondary Outcome Measures
Name Time Method Assess antibiotic usage relative to treatment assignment 1 week post-op through week 16 Assess week 16 post-FESS Sino-Nasal Outcome Test-22 (SNOT-22) group scores change from baseline relative to treatment assignment Week 16 post-FESS
Trial Locations
- Locations (1)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States