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

House Ear Institute

Status and phase: Active, not recruiting; Phase 4

Conditions: Vertigo; Meniere Disease; Allergic Rhinitis

Treatments: Drug: Montelukast; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04815187

20203338

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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39 participants in 2 patient groups, including a placebo group

Montelukast 10 mg

Experimental group

Description:

Subjects will be instructed to take one pill at night for 90 days

Treatment:

Drug: Montelukast

Placebo

Placebo Comparator group

Description:

Subjects will be instructed to take one pill at night for 90 days

Treatment:

Drug: Placebo