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

Browse trials for

• Sinusitis 415

Keywords

• Surgery

Sinusitis

415 studies on the registry are indexed under Sinusitis; 46 are open to participants now.

This study's planned enrollment of 99 is above the median of 60 across 313 interventional studies indexed under Sinusitis.

Lead sponsor

GeneOne Life Science, Inc. is the lead sponsor of 13 studies on the registry; none are open to participants now.

Study arms

• Experimental
  GLS-1200

  3 ml of GLS-1200 (1 mg/ml in 0.9% saline)

  Drug: GLS-1200

• Placebo comparator
  Sterile Saline

  3 ml of 0.9% saline

  Drug: Placebo

Interventions

• DrugGLS-1200

  GLS-1200 is given as a nasal spray using an atomizer

• DrugPlacebo

  Placebo is given as a nasal spray using an atomizer

  Also known as: Sterile Saline

Primary outcomes

1. Safety measures: treatment emergent adverse events by group will be summarized as frequencies by severity and relationship to treatment

   Time frame: Post-op through week 16 post-FESS

2. Assess the incidence of post-operative acute rhinosinusitis relative to treatment assignment

   Time frame: Post-op through week 16 post-FESS

Secondary outcomes

1. Assess week 16 post-FESS Sino-Nasal Outcome Test-22 (SNOT-22) group scores change from baseline relative to treatment assignment

   Time frame: Week 16 post-FESS

2. Assess antibiotic usage relative to treatment assignment

   Time frame: 1 week post-op through week 16

Individual participant data

Plan to share: No