Allergic Rhinitis, Meniere Disease, Vertigo
Conditions
Brief summary
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.
Interventions
DRUGMontelukast
Each subject will be given a drug diary to record when they took the drug and any symptoms that they are experiencing, and will bring this diary and any unused pills to their next clinic visit before receiving the next 30-day supply. This process will continue for the full 90 days of study involvement, with a final visit 3 months later.
DRUGPlacebo
Each subject will be given a drug diary to record when they took the drug and any symptoms that they are experiencing, and will bring this diary and any unused pills to their next clinic visit before receiving the next 30-day supply. This process will continue for the full 90 days of study involvement, with a final visit 3 months later.
Sponsors
Cures Within Reach
House Ear Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients with AAO-HNS Vertigo Control Class A or B | 1 month 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 | 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 | 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. |
Countries
United States
Outcome results
None listed