Directed Topical Drug Delivery for Treatment for PASC Hyposmia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in olfactory function as measured by the Smell Identification Test (SIT)
研究概览
简要总结
This is a phase II randomized, double-blinded, placebo-controlled study to evaluate the efficacy of topical intranasal treatment of beclomethasone vs. placebo for improved olfactory function.
详细描述
Eligible participants are randomized to receive either Beclomethasone or placebo intranasally via a microsponge twice on day 1 and day 14. Study duration is three months and includes 4 in-person study visits: 2 visits for drug administration at Baseline and Week 2, and 2 follow-up visits at Week 6 and Week 18. Participants will be expected to complete the Smell Identification Test (SIT) and Questionnaire on Olfactory Disorders (QOD) at baseline, Week 6, and Week 18. The investigator hypothesizes that the application of beclomethasone directly in the nasal cavity will result in improved olfactory function.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Post-COVID hyposmia lasting greater than 3 months following COVID19 by history
- •Male or female, aged 18 years or older
排除标准
- •Pregnancy or lactation
- •Known allergic reactions to components of microsponge (including shellfish) or to beclomethasone
- •Known diagnosis of glaucoma
- •Febrile illness within 1 week
- •Treatment with another investigational drug or other intervention within 3 months
- •Active sinonasal disease by nasal exam, i.e. rhinosinusitis, nasal polyps
- •Adults unable to consent
- •Prisoners, employees or subordinates
- •Individuals who are not yet adults (infants, children, teenagers)
研究组 & 干预措施
Beclomethasone
84 mcg of Beclomethasone administered twice in each nostril via a microsponge (Day 1 and Day 14)
干预措施: Beclomethasone (Drug)
Beclomethasone
84 mcg of Beclomethasone administered twice in each nostril via a microsponge (Day 1 and Day 14)
干预措施: Microsponge (Device)
Placebo
Placebo (0.9% sodium chloride) administered twice in each nostril via a microsponge (Day 1 and Day 14)
干预措施: Placebo (Other)
Placebo
Placebo (0.9% sodium chloride) administered twice in each nostril via a microsponge (Day 1 and Day 14)
干预措施: Microsponge (Device)
结局指标
主要结局
Change in olfactory function as measured by the Smell Identification Test (SIT)
时间窗: Baseline, 6 weeks, 18 weeks
The SIT has a score range of 0 to 40, where a higher score reflects better olfactory function.
次要结局
- Change in olfactory quality of life (QOL) measured by the Questionnaire on Olfactory Disorders (QOD)(Baseline, 6 weeks, 18 weeks)