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

January 10, 2023 updated by: GeneOne Life Science, Inc.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

99

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety measures: treatment emergent adverse events by group will be summarized as frequencies by severity and relationship to treatment
Time Frame: Post-op through week 16 post-FESS
Post-op through week 16 post-FESS
Assess the incidence of post-operative acute rhinosinusitis relative to treatment assignment
Time Frame: Post-op through week 16 post-FESS
Post-op through week 16 post-FESS

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess week 16 post-FESS Sino-Nasal Outcome Test-22 (SNOT-22) group scores change from baseline relative to treatment assignment
Time Frame: Week 16 post-FESS
Week 16 post-FESS
Assess antibiotic usage relative to treatment assignment
Time Frame: 1 week post-op through week 16
1 week post-op through week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GeneOne Life Science, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

August 13, 2019

First Submitted That Met QC Criteria

August 14, 2019

First Posted (Actual)

August 19, 2019

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T2R-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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