UnknownPhase 2

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

United States99 participantsStarted 2023-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Post-op through week 16 post-FESS

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

Timeframe: Post-op through week 16 post-FESS

Trial details

NCT IDNCT04060316

SponsorGeneOne Life Science, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12

Contact for this trial

Medical Monitor

484-965-9147 jmaslow@genels.us

View on ClinicalTrials.gov More Sinusitis Chronic trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Post-op through week 16 post-FESS

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

Timeframe: Post-op through week 16 post-FESS