GLS-1200 Topical Nasal Spray to Prevent Sinusitis After Endoscopic Sinus Surgery
Efficacy, Safety, and Tolerability of Adjuvant GLS-1200 Topical Nasal Spray in the Prevention of Acute Rhinosinusitis Following Functional Endoscopic Sinus Surgery (FESS)
1 other identifier
interventional
99
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2023
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2019
CompletedFirst Posted
Study publicly available on registry
August 19, 2019
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedJanuary 11, 2023
January 1, 2023
Same day
August 13, 2019
January 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (2)
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
Assess antibiotic usage relative to treatment assignment
1 week post-op through week 16
Study Arms (2)
GLS-1200
EXPERIMENTAL3 ml of GLS-1200 (1 mg/ml in 0.9% saline)
Sterile Saline
PLACEBO COMPARATOR3 ml of 0.9% saline
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2019
First Posted
August 19, 2019
Study Start
December 1, 2023
Primary Completion
December 1, 2023
Study Completion
September 1, 2024
Last Updated
January 11, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share