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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sinusitis Chronic

Intervention / Treatment
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* Drug: GLS-1200
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLS-1200<br>3 ml of GLS-1200 (1 mg/ml in 0.9% saline) | Drug: GLS-1200<br>* GLS-1200 is given as a nasal spray using an atomizer<br>|
| Placebo Comparator: Sterile Saline<br>3 ml of 0.9% saline | Drug: Placebo<br>* Placebo is given as a nasal spray using an atomizer<br>* Other names: Sterile Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Assess antibiotic usage relative to treatment assignment |  | 1 week post-op through week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery