Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04815187
• Other study ID #: 20203338
• Status: Recruiting
• Phase: Phase 4
• Start date: June 7, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: House Ear Institute
• Contact: Sean Lang
• Phone: (213) 770-1808
• Email: clinicaltrials[@]hifla.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Dizziness
• Hearing Loss
• Meniere Disease
• Rhinitis
• Rhinitis, Allergic
• Vertigo

Intervention

Drug:
• Montelukast
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.
• Placebo
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.

Locations

Country	Name	City	State
United States	House Ear Clinic	Los Angeles	California
United States	House Institute Foundation	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
House Ear Institute	Cures Within Reach

Country where clinical trial is conducted

United States, 

Outcome

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