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

Sinusitis Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04060316
• Other study ID #: T2R-001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 2023
• Est. completion date: September 2024

Study information

• Verified date: January 2023
• Source: GeneOne Life Science, Inc.
• Contact: Medical Monitor
• Phone: 484-965-9147
• Email: jmaslow[@]genels.us
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 99
• Est. completion date: September 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sinusitis
• Sinusitis Chronic

Intervention

Drug:
• GLS-1200
GLS-1200 is given as a nasal spray using an atomizer
• Placebo
Placebo is given as a nasal spray using an atomizer

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
GeneOne Life Science, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Assess the incidence of post-operative acute rhinosinusitis relative to treatment assignment		Post-op through week 16 post-FESS
Secondary	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
Secondary	Assess antibiotic usage relative to treatment assignment		1 week post-op through week 16