Status:
UNKNOWN
GLS-1200 Topical Nasal Spray to Prevent Sinusitis After Endoscopic Sinus Surgery
Lead Sponsor:
GeneOne Life Science, Inc.
Conditions:
Sinusitis Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT04060316
Start Date
December 1 2023
End Date
September 1 2024
Last Update
January 11 2023
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104