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GLS-1200 Nasal Spray for Chronic Sinusitis

Phase 2

Waitlist Available

Research Sponsored by GeneOne Life Science, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Elective FESS

Age 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week post-op through week 16

Awards & highlights

Study Summary

This trial will test a new nasal spray to see if it's safe and effective for people with chronic sinusitis who have had surgery.

Who is the study for?

Adults over 18 with chronic sinusitis who've had or will have elective endoscopic sinus surgery can join. They must be able to follow the study plan and give informed consent. Women should use birth control if they can have children. People with latex allergies, certain medical histories like blood cancers, bone marrow transplants, or those on chemotherapy are excluded.Check my eligibility

What is being tested?

The trial is testing GLS-1200 nasal spray's safety and how well it works in preventing sinus infections after sinus surgery compared to a placebo (a treatment with no active drug). Participants will receive either the real spray or placebo alongside standard post-surgery care.See study design

What are the potential side effects?

Possible side effects of GLS-1200 aren't detailed here but may include typical reactions to nasal sprays such as irritation, discomfort, or an allergic reaction. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for elective sinus surgery.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week post-op through week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week post-op through week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week post-op through week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

Assess antibiotic usage relative to treatment assignment

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: GLS-1200Experimental Treatment1 Intervention

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

Group II: Sterile SalinePlacebo Group1 Intervention

3 ml of 0.9% saline

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

GeneOne Life Science, Inc.Lead Sponsor

15 Previous Clinical Trials

1,341 Total Patients Enrolled

Media Library

GLS-1200 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04060316 — Phase 2

Chronic Sinusitis Research Study Groups: GLS-1200, Sterile Saline

Chronic Sinusitis Clinical Trial 2023: GLS-1200 Highlights & Side Effects. Trial Name: NCT04060316 — Phase 2

GLS-1200 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04060316 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research experiment still accepting participants?

"According to clinicaltrials.gov, this experiment is not presently accepting applicants; its initial posting was on February 1st 2022 and it last underwent revisions on October 13th 2021. Although no longer enrolling candidates, there are 53 other trials actively seeking patients at present."

Answered by AI

What potential hazards are associated with GLS-1200?

"Based on the research conducted by Power, GLS-1200 was rated a 2 in regards to safety due to its Phase 2 status; data exists regarding the drug's security but not yet supporting its effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "GLS-1200 Topical Nasal Spray to Prevent Sinusitis After Endoscopic Sinus Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04060316.