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

GeneOne Life Science

Status and phase: Not yet enrolling; Phase 2

Conditions: Sinusitis Chronic

Treatments: Drug: Placebo; Drug: GLS-1200

Study type: Interventional

Funder types: Industry

Identifiers

NCT04060316

T2R-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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99 participants in 2 patient groups, including a placebo group

GLS-1200

Experimental group

Description:

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

Treatment:

Drug: GLS-1200

Sterile Saline

Placebo Comparator group

Description:

3 ml of 0.9% saline

Treatment:

Drug: Placebo