Back to resultsGLS-1200 Topical Nasal Spray to Prevent Sinusitis After Endoscopic Sinus Surgery
Primary Purpose
Sinusitis Chronic
Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GLS-1200
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sinusitis Chronic focused on measuring Surgery
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
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GLS-1200
Sterile Saline
Arm Description
3 ml of GLS-1200 (1 mg/ml in 0.9% saline)
3 ml of 0.9% saline
Outcomes
Primary Outcome Measures
Safety measures: treatment emergent adverse events by group will be summarized as frequencies by severity and relationship to treatment
Assess the incidence of post-operative acute rhinosinusitis relative to treatment assignment
Secondary Outcome Measures
Assess week 16 post-FESS Sino-Nasal Outcome Test-22 (SNOT-22) group scores change from baseline relative to treatment assignment
Assess antibiotic usage relative to treatment assignment
Full Information
NCT ID
NCT04060316
First Posted
August 13, 2019
Last Updated
January 10, 2023
Sponsor
GeneOne Life Science, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04060316
Brief Title
GLS-1200 Topical Nasal Spray to Prevent Sinusitis After Endoscopic Sinus Surgery
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GeneOne Life Science, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis Chronic
Keywords
Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
99 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GLS-1200
Arm Type
Experimental
Arm Description
3 ml of GLS-1200 (1 mg/ml in 0.9% saline)
Arm Title
Sterile Saline
Arm Type
Placebo Comparator
Arm Description
3 ml of 0.9% saline
Intervention Type
Drug
Intervention Name(s)
GLS-1200
Intervention Description
GLS-1200 is given as a nasal spray using an atomizer
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sterile Saline
Intervention Description
Placebo is given as a nasal spray using an atomizer
Primary Outcome Measure Information:
Title
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
Title
Assess the incidence of post-operative acute rhinosinusitis relative to treatment assignment
Time Frame
Post-op through week 16 post-FESS
Secondary Outcome Measure Information:
Title
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
Title
Assess antibiotic usage relative to treatment assignment
Time Frame
1 week post-op through week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical Monitor
Phone
484-965-9147
Email
jmaslow@genels.us
First Name & Middle Initial & Last Name or Official Title & Degree
Project Manager
Email
dkane@genels.us
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Tebas, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
GLS-1200 Topical Nasal Spray to Prevent Sinusitis After Endoscopic Sinus Surgery
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