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

Sponsor
GeneOne Life Science, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04060316
Collaborator
(none)
99
Enrollment
1
Location
2
Arms
19
Anticipated Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
99 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy, Safety, and Tolerability of Adjuvant GLS-1200 Topical Nasal Spray in the Prevention of Acute Rhinosinusitis Following Functional Endoscopic Sinus Surgery (FESS)
Anticipated Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: GLS-1200

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

Drug: GLS-1200
GLS-1200 is given as a nasal spray using an atomizer
Placebo Comparator: Sterile Saline

3 ml of 0.9% saline

Drug: Placebo
Placebo is given as a nasal spray using an atomizer
Other Names:
  • Sterile Saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    2. Assess the incidence of post-operative acute rhinosinusitis relative to treatment assignment [Post-op through week 16 post-FESS]

    Secondary Outcome Measures

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

    2. Assess antibiotic usage relative to treatment assignment [1 week post-op through week 16]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • GeneOne Life Science, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GeneOne Life Science, Inc.
    ClinicalTrials.gov Identifier:
    NCT04060316
    Other Study ID Numbers:
    • T2R-001
    First Posted:
    Aug 19, 2019
    Last Update Posted:
    Oct 14, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by GeneOne Life Science, Inc.
    Surgery
    Additional relevant MeSH terms:
    Sinusitis

    Study Results

    No Results Posted as of Oct 14, 2021