Clinical trial

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

Name

T2R-001

Description

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.

Trial arms

Trial start

2023-12-01

Estimated PCD

2023-12-01

Trial end

2024-09-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

GLS-1200

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

Arms:

GLS-1200

Placebo

Placebo is given as a nasal spray using an atomizer

Arms:

Sterile Saline

Other names:

Sterile Saline

Size

Primary endpoint

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

Post-op through week 16 post-FESS

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

Post-op through week 16 post-FESS

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 99, 'type': 'ESTIMATED'}}

Updated at

2023-01-11

1 organization

2 products

1 indication

Product

Indication

Product

Organization