NCT04060316

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: GeneOne Life Science, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sinusitis Chronic

Interventions

Type	Name	Description
DRUG	GLS-1200	GLS-1200 is given as a nasal spray using an atomizer
DRUG	Placebo	Placebo is given as a nasal spray using an atomizer

Timeline

• Start date: 2023-12-01
• Primary completion: 2023-12-01
• Completion: 2024-09-01
• First posted: 2019-08-19
• Last updated: 2023-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study