Allergic Rhinitis Clinical Trial
Official title:
Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults 18 years of age or older - Must meet all AAO-HNS 2020 criteria for definite 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 |
Country | Name | City | State |
---|---|---|---|
United States | House Ear Clinic | Los Angeles | California |
United States | House Institute Foundation | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
House Ear Institute | Cures Within Reach |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Patients with AAO-HNS Vertigo Control Class A or B | 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) | 1 month after treatment initiation | |
Primary | Percentage of Patients with AAO-HNS Vertigo Control Class A or B | 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) | 3 months after treatment initiation | |
Primary | Percentage of Patients with AAO-HNS Vertigo Control Class A or B | 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) | 6 months after treatment initiation | |
Primary | Difference in Dizziness Between Treatment Arms | 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. | 3 months after treatment initiation | |
Primary | Percentage of Subjects Experiencing Significant Hearing Fluctuation | 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. | 3 months after treatment initiation |
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