Montelukast for Meniere's Disease

Recruiting at 1 trial location

Overseen By Sean Lang

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: House Ear Institute

Must not be taking: Montelukast, Beta-blockers

Disqualifiers: Surgical vertigo, Pregnancy, Hospitalization, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

39 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing an allergy medicine to see if it can help people with Meniere's Disease by reducing their symptoms.

Will I have to stop taking my current medications?

The trial requires that you are not currently taking montelukast, allergy immunotherapy, or a beta-blocker. If you are on these medications, you would need to stop them to participate.

Will I have to stop taking my current medications?

The trial requires that you are not currently taking montelukast or a beta-blocker, and you cannot be receiving allergy immunotherapy. If you are on these medications, you would need to stop them to participate.

Is montelukast generally safe for humans?

Montelukast (Singulair) has been studied for safety in various conditions, including asthma and middle ear effusion. It is generally well-tolerated, with mild side effects like dyspepsia (indigestion) and throat pain reported in some cases. However, in rare instances, it might be associated with Churg-Strauss syndrome, a condition that causes blood vessel inflammation. ^{1 2 3 4 5}

Is montelukast generally safe for humans?

Montelukast (Singulair) has been studied for safety in various conditions, including asthma and middle ear effusion, and is generally well-tolerated with a similar safety profile to placebo. Some mild side effects like dyspepsia (indigestion) and throat pain have been reported, and in rare cases, it might be associated with Churg-Strauss syndrome (a rare disease causing blood vessel inflammation). ^{1 2 3 4 5}

How does the drug montelukast differ from other treatments for Meniere's disease?

Montelukast is unique because it is a leukotriene-receptor antagonist (a type of drug that blocks certain chemicals in the body that cause inflammation) and is typically used for asthma and allergies, not Meniere's disease. This makes its use in Meniere's disease novel, as it targets inflammation differently than other treatments for this condition. ^{3 4 5 6 7}

How does the drug montelukast differ from other treatments for Meniere's disease?

Montelukast is unique for Meniere's disease as it is a leukotriene-receptor antagonist (LTRA) typically used for asthma and allergic rhinitis, working by blocking substances in the body that cause inflammation. This mechanism is different from other treatments for Meniere's disease, which often focus on reducing fluid in the inner ear or managing symptoms like vertigo. ^{3 4 5 6 7}

Research Team

Mary J Derebery, MD

Principal Investigator

House Institute Foundation

Eligibility Criteria

This trial is for adults over 18 with definite Meniere's Disease, as per AAO-HNS 2020 criteria, who also test positive for allergies and have not had success with standard allergy treatments. It's specifically aimed at those already considered for montelukast therapy.

Inclusion Criteria

Must have a skin test positive for allergy

I am a candidate for montelukast due to my severe allergies.

I have been diagnosed with definite Meniere's Disease according to AAO-HNS 2020 criteria.

Exclusion Criteria

I am currently in the hospital.

Pregnant or recent pregnancy (≤ 8 weeks postpartum), or lactation

I am currently on allergy shots or taking montelukast or a beta-blocker.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take one pill at night for 90 days, either Montelukast 10 mg or placebo

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Montelukast
• Placebo

Trial Overview The study tests whether montelukast, a drug approved for allergic rhinitis and asthma, can alleviate vertigo and hearing loss in Meniere's Disease patients. Participants will either receive montelukast or a placebo to compare outcomes.

Participant Groups

Group I: Montelukast 10 mg Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Montelukast is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Singulair for:

• Asthma
• Exercise-induced bronchoconstriction
• Allergic rhinitis

Approved in Canada as Singulair for:

• Asthma
• Exercise-induced bronchoconstriction
• Allergic rhinitis

Approved in European Union as Singulair for:

• Asthma
• Exercise-induced bronchoconstriction
• Allergic rhinitis

Who Is Running the Clinical Trial?

House Ear Institute

Lead Sponsor

Trials

2

Recruited

140+

Cures Within Reach

Collaborator

Trials

25

Recruited

2,100+

Findings from Research

In a study involving 506 children aged 2 to 18 with mild to moderate persistent asthma, montelukast (Singulair) significantly improved asthma symptoms and treatment compliance over a 6-week period.

The treatment was well-received by both pediatricians and parents, indicating high satisfaction with montelukast as an effective monotherapy for managing childhood asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-life effectiveness of Singulair (montelukast) in 506 children with mild to moderate asthma. Amirav, I.[2021]

Montelukast sodium, administered intravenously in doses ranging from 3 to 18 mg, showed linear pharmacokinetics in healthy males, with consistent safety and tolerability across all doses.

Both males and females demonstrated similar pharmacokinetic profiles for montelukast sodium, with oral bioavailability averaging around 66% for males and 58% for females, indicating effective absorption regardless of gender.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, bioavailability, and safety of montelukast sodium (MK-0476) in healthy males and females. Cheng, H., Leff, JA., Amin, R., et al.[2022]

A study involving 40 healthy male volunteers demonstrated that Sandoz generic montelukast 4 mg oral granules are bioequivalent to Singulair(®) 4 mg mini oral granules, meaning they have similar absorption and effectiveness in the body.

Both formulations showed a comparable safety profile, with only two mild adverse events reported, indicating that they can be used interchangeably in treating asthma and allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioequivalence of two formulations of montelukast sodium 4 mg oral granules in healthy adults. Fey, C., Thyroff-Friesinger, U., Jones, S.[2021]

Montelukast is effective in improving clinical scores and respiratory function in patients with chronic asthma and in preventing effort-induced asthma, based on several placebo-controlled trials.

While montelukast has not been directly compared to all standard treatments for asthma, it may be superior to salmeterol for effort-induced asthma, and it generally has a similar side effect profile to placebo, though rare cases of Churg-Strauss syndrome have been reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Montelukast. No current use for asthma. [2021]

In a randomized, double-blind study involving 38 children aged 2 to 6 years with persistent otitis media with effusion, montelukast did not show any significant effect in clearing middle ear drainage compared to placebo.

After one month of treatment, only 15.8% of patients taking montelukast and 21.1% of those on placebo experienced clearance of effusion, leading to the conclusion that montelukast is not effective for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, randomized, placebo-controlled, double-blind study of montelukast's effect on persistent middle ear effusion. Schoem, SR., Willard, A., Combs, JT.[2021]

Montelukast sodium is a safe and effective oral medication that acts as a leukotriene-receptor antagonist, specifically targeting the CysLT1 receptor, making it useful for preventing asthma and allergic rhinitis in both adults and children.

Clinical trials have demonstrated that montelukast effectively reduces inflammation and symptoms associated with asthma and allergic rhinitis, highlighting its role in managing these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of montelukast in the treatment of asthma and allergic rhinitis. Nayak, A.[2021]

In a study of 120 children aged 2-6 with otitis media with effusion (OME), the combination of montelukast and levocetirizine significantly improved clinical signs of middle ear fluid compared to other treatment groups.

While the combination therapy showed greater improvement in tympanometric findings, the difference was not statistically significant, indicating that while effective, further research may be needed to confirm the extent of its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of combination of montelukast and levocetirizine on otitis media with effusion: a prospective, placebo-controlled trial. Ertugay, CK., Cingi, C., Yaz, A., et al.[2021]

References

1. Israel pubmed.ncbi.nlm.nih.gov

Real-life effectiveness of Singulair (montelukast) in 506 children with mild to moderate asthma. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, bioavailability, and safety of montelukast sodium (MK-0476) in healthy males and females. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Bioequivalence of two formulations of montelukast sodium 4 mg oral granules in healthy adults. [2021]

4. Canada pubmed.ncbi.nlm.nih.gov

Montelukast. No current use for asthma. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

A prospective, randomized, placebo-controlled, double-blind study of montelukast's effect on persistent middle ear effusion. [2021]

6. England pubmed.ncbi.nlm.nih.gov

A review of montelukast in the treatment of asthma and allergic rhinitis. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Effect of combination of montelukast and levocetirizine on otitis media with effusion: a prospective, placebo-controlled trial. [2021]