What side effects are associated with this type of intervention?

Common treatments for asthma, such as leukotriene receptor antagonists like montelukast, inhaled corticosteroids (ICS), and long-acting beta-agonists (LABA), have various side effects. Montelukast can cause headaches, abdominal pain, and in rare cases, neuropsychiatric events such as agitation, depression, and suicidal thoughts. Inhaled corticosteroids may lead to oral thrush, hoarseness, and, with long-term use, potential bone density reduction. LABAs can cause muscle cramps, palpitations, and, in some cases, increased risk of asthma-related death if not used with ICS. Combination therapies (ICS/LABA) generally combine the side effects of both components but are often well-tolerated when used correctly.

What prior FDA approvals exist?

The FDA has approved several treatments for asthma, including leukotriene receptor antagonists like montelukast, which is used to manage and prevent asthma symptoms. Montelukast works by blocking leukotrienes, substances in the body that cause asthma symptoms. Other related drugs include zafirlukast, another leukotriene receptor antagonist, and zileuton, a leukotriene synthesis inhibitor. These medications are part of a broader category of asthma treatments that also include inhaled corticosteroids, long-acting beta-agonists (LABAs), and biologics such as mepolizumab and omalizumab, which target specific pathways involved in asthma inflammation.

What other types of research exist?

Promising novel alternatives to high-dose oral montelukast for asthma patients include biologic therapies such as omalizumab (anti-IgE antibody), benralizumab (anti-IL-5 receptor antibody), and lebrikizumab (anti-IL-13 antibody). These biologics have demonstrated efficacy in reducing asthma exacerbations and improving lung function in patients with severe asthma. Additionally, IL-17 inhibitors like secukinumab and JAK inhibitors such as tofacitinib and upadacitinib are also emerging as potential treatments for asthma.

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Bronchodilator

Montelukast for Childhood Asthma (TEAM Trial)

Phase 2

Recruiting

Led By Donald H Arnold, MD, MPH

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Child aged 4 - 12 years with doctor-diagnosed asthma

Presents to the Vanderbilt Children's Hospital with an acute asthma exacerbation that is moderate or severe (AAIRS >7) after initial treatment with inhaled albuterol

Must not have

Acute or chronic liver disease

History of anxiety disorder, depression and/or other neuropsychiatric disorder except ADHD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 hours

Summary

This trial is testing montelukast in children aged 4-12 with severe asthma attacks that don't respond well to standard treatments. Montelukast helps by blocking substances that cause airway inflammation, potentially improving breathing. The study aims to find the right dose that improves asthma symptoms.

Who is the study for?

This trial is for children aged 4-12 with doctor-diagnosed asthma, who come to Vanderbilt Children's Hospital with a moderate or severe asthma attack after albuterol treatment. They must not have liver disease, allergy to montelukast, significant breast development in girls, acid reflux on medication, certain mental health conditions except ADHD, or high risk of suicide.

What is being tested?

The study tests if high-dose oral montelukast added to standard care (albuterol and corticosteroids) can improve symptoms more than standard care alone in kids with serious asthma attacks. It's a blinded trial where doses are adjusted based on drug levels in the blood and response.

What are the potential side effects?

Montelukast may cause side effects like stomach pain, headache, thirstiness; rarely it might affect mood or behavior. Albuterol can lead to jitteriness or heart palpitations. Corticosteroids could cause weight gain and changes in mood.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child, aged 4-12, has been diagnosed with asthma by a doctor.

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My child's asthma got worse even after using albuterol.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have liver disease.

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I have a history of anxiety, depression, or another mental health condition, but not ADHD.

Select...

I take medication for acid reflux.

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I am a female and my breasts have started to develop.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Montelukast plasma level

Secondary study objectives

Airway resistance by impulse oscillometry (IOS)

Change of Acute Asthma Intensity Research Score

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: High-dose oral montelukast plus standard treatmentExperimental Treatment3 Interventions

Escalating dose-levels of oral montelukast between 2 mg/kg and 3 mg/kg determined by pharmacokinetic-guided dose modeling, added to standard, guideline-based treatment (systemic corticosteroid, inhaled albuterol, and possible treatment adjuncts such as IV magnesium, determined by evidence-based asthma clinical practice guideline).

Group II: Identical placebo plus standard treatmentPlacebo Group2 Interventions

Guideline-based treatment (systemic corticosteroid, inhaled albuterol, and possible treatment adjuncts such as IV magnesium, determined by evidence-based asthma clinical practice guideline).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Albuterol

2012

Completed Phase 4

~2190

Corticosteroid

2005

Completed Phase 4

~2210

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Asthma treatments primarily aim to reduce inflammation and relax the airways. Inhaled corticosteroids (ICS) reduce airway inflammation, preventing asthma symptoms and exacerbations. Long-acting beta agonists (LABAs) relax the muscles around the airways, making breathing easier. Leukotriene receptor antagonists (LTRAs), such as montelukast, block the action of leukotrienes—chemicals that cause airway inflammation and constriction. This is particularly important for patients with persistent asthma, as LTRAs can help control symptoms and reduce the frequency of exacerbations. Combination therapies often include ICS and LABAs to provide both anti-inflammatory and bronchodilatory effects, offering comprehensive management of asthma symptoms.