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UNKNOWNPhase 2NCT04060316

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

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...

Lead sponsor: GeneOne Life Science, Inc.•1 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Medical Monitor

CONTACT

484-965-9147 [email protected]

Project Manager

CONTACT

[email protected]

Sponsors

Lead Sponsor

GeneOne Life Science, Inc.

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 11, 2023Terms

Trial snapshot

StatusUNKNOWN

PhasePHASE2

Enrollment99

Start dateDec 2023

Last updatedJan 11, 2023

Condition

Sinusitis Chronic

Locations shown

University of Pennsylvania

Philadelphia, Pennsylvania

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 11, 2023Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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