Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Percentage of Patients with AAO-HNS Vertigo Control Class A or B
研究概览
简要总结
The purpose of this study is to evaluate a previously FDA-approved medication that is known to help with allergy symptoms to see if it can decrease symptoms in patients with Meniere's Disease.
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
- •Adults 18 years of age or older
- •Must meet all AAO-HNS 2020 criteria for definite or probable Meniere's Disease
- •Must have a skin test positive for allergy
- •Is already a candidate for treatment with montelukast for allergic rhinitis/failed first line over-the-counter allergy treatments
排除标准
- •Had a previous surgical procedure for treatment of vertigo
- •Currently receiving any allergy immunotherapy or taking montelukast or a beta-blocker
- •Pregnant or recent pregnancy ((≤ 8 weeks postpartum), or lactation)
- •Current hospitalization for any reason
- •Any active, acute, or chronic pulmonary disorder other than asthma
- •History of intubation for asthma
研究组 & 干预措施
Montelukast 10 mg
Subjects will be instructed to take one pill at night for 90 days
干预措施: Montelukast (Drug)
Placebo
Subjects will be instructed to take one pill at night for 90 days
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Patients with AAO-HNS Vertigo Control Class A or B
时间窗: 6 months after treatment initiation
Percentage of patients in each group with an AAO-HNS Vertigo Control Class A or B result (from daily diary count of number of attacks)
Difference in Dizziness Between Treatment Arms
时间窗: 3 months after treatment initiation
Difference for each group in AAO-HNS dizziness functional disability scale from pre-treatment to 3 months after treatment initiation. A score improvement of 1 point on this 6-point scale will be considered significant improvement.
Percentage of Subjects Experiencing Significant Hearing Fluctuation
时间窗: 3 months after treatment initiation
Percentage of subjects in each treatment arm demonstrating clinically significant change in air conduction thresholds at \> 2 frequencies at 3 months (\> 10 dB change from baseline) or WDS (\> 15% change from baseline) compared to the worst audiogram and WDS in the 6 months prior to treatment initiation.
次要结局
未报告次要终点