Efficacy, Safety, and Tolerability of Adjuvant GLS-1200 Topical Nasal Spray in the Prevention of Acute Rhinosinusitis Following Functional Endoscopic Sinus Surgery (FESS)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Safety measures: treatment emergent adverse events by group will be summarized as frequencies by severity and relationship to treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
GLS-1200
3 ml of GLS-1200 (1 mg/ml in 0.9% saline)
干预措施: GLS-1200 (Drug)
Sterile Saline
3 ml of 0.9% saline
干预措施: Placebo (Drug)
结局指标
主要结局
Safety measures: treatment emergent adverse events by group will be summarized as frequencies by severity and relationship to treatment
时间窗: Post-op through week 16 post-FESS
Assess the incidence of post-operative acute rhinosinusitis relative to treatment assignment
时间窗: Post-op through week 16 post-FESS
次要结局
- Assess antibiotic usage relative to treatment assignment(1 week post-op through week 16)
- 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)