Sinusitis Chronic
Conditions
Keywords
Surgery
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.
Interventions
DRUGGLS-1200
GLS-1200 is given as a nasal spray using an atomizer
DRUGPlacebo
Placebo is given as a nasal spray using an atomizer
Sponsors
GeneOne Life Science, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactMedical Monitor
Backup ContactProject Manager
Outcome results
None listed