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Could a higher dose of an old asthma drug help kids breathe easier in an emergency?

NCT ID NCT05819541

Disease control Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests whether a high dose of montelukast (Singulair), given by mouth, can help children aged 4 to 12 who are in the hospital with a moderate or severe asthma attack. The goal is to find the best dose for a future larger study. Children receive either the high-dose montelukast plus standard care (albuterol and steroids) or standard care alone. Researchers measure drug levels in the blood and track how quickly symptoms improve.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Montelukast (Singulair)
What this could lead to
If successful, this could lead to a new treatment option for children having severe asthma attacks, potentially reducing hospital stays and improving breathing faster.
What could go wrong
This is an early-phase dose-finding study, not a proof of effectiveness. The drug may not improve outcomes, and high doses could cause side effects like headache or stomach upset.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

90 people

The number who actually took part.

Started

Oct 2023

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * The parent agrees to phone and/or mail follow-up at 2-3 weeks for completion of SCARED and side-effect questionnaires. Exclusion Criteria: * Gestational age \< 34 weeks * acute or chronic liver disease * allergy to montelukast * female with any evidence of Tanner stage 2 or greater breast development * gastroesophageal reflux requiring acid-blocking medication * history of anxiety disorder, depression and/or other neuropsychiatric disorder except ADHD * positive on question 1 or 2 of the Columbia Suicide Severity Rating Scale (CSSR-S) * score \>25 on the 82-point Screen for Child Anxiety Related Disorders (SCARED) questionnaire * Patients currently receiving daily montelukast (4 or 5 mg) will not be excluded from study participation.

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Conditions

The condition(s) this trial relates to.

acute asthma status asthmaticus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Status asthmaticus

Contacts and locations

Locations

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    Nashville, Tennessee, 37232-9001, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.