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

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GeneOne Life Science, Inc.
• Treatments: Quinine

Criteria

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