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High-Dose Montelukast for Childhood Asthma

Phase 2

Waitlist Available

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

Age 5 to 17 years, inclusive

Parental report of asthma diagnosis by a health care provider

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8-hours after treatment with montelukast or placebo

Awards & highlights

Study Summary

This trial is testing whether high-dose oral montelukast, added to standard treatment, rapidly improves symptoms in children with moderate and severe acute asthma exacerbations.

Who is the study for?

This trial is for children aged 5 to 17 with moderate or severe acute asthma exacerbations who've had at least one previous wheezing episode treated with albuterol. They must have a parental report of an asthma diagnosis by a healthcare provider. Kids can't join if they have chronic lung diseases other than asthma, liver disease, were born prematurely before 34 weeks, need airway intervention, are allergic to montelukast, or use certain medications.Check my eligibility

What is being tested?

The study tests whether high-dose oral montelukast (30mg), added to standard treatment for pediatric acute asthma exacerbations, improves lung function and reduces hospitalization rates and symptoms within 72 hours. It's a two-arm trial comparing this approach against placebo in addition to the usual care.See study design

What are the potential side effects?

While not explicitly stated here, common side effects of montelukast may include abdominal pain, thirstiness, headache and sleep disturbances. In rare cases it might cause mood-related changes.

Eligibility Criteria

Inclusion Criteria

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

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I am between 5 and 17 years old.

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My child's asthma has been diagnosed by a doctor.

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My asthma attack is moderate or severe according to the AAIRS score.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and at 72-hours after treatment with montelukast or placebo

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and at 72-hours after treatment with montelukast or placebo

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and at 72-hours after treatment with montelukast or placebo for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change of percent-predicted airway resistance at 5Hz (%R5) by impulse oscillometry

Secondary outcome measures

72-hours symptom burden measured using the pediatric asthma caregiver diary (PACD)

Change of percent-predicted forced expiratory volume in 1-second (FEV1)

Change of the Acute Asthma Intensity Research Score (AAIRS)

+2 more

Side effects data

From 2013 Phase 3 trial • 220 Patients • NCT01857063

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Study treatment Arm

Montelukast

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: High-dose Montelukast Oral GranulesExperimental Treatment1 Intervention

30 mg (high-dose) oral montelukast granules mixed in apple sauce will be administered orally immediately after informed consent and assent are obtained.

Group II: PlaceboPlacebo Group1 Intervention

Identical placebo mixed in apple sauce will be administered orally immediately after informed consent and assent are obtained.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

671,877 Total Patients Enrolled

12 Trials studying Asthma

4,375 Patients Enrolled for Asthma

Donald H Arnold, MD, MPHPrincipal InvestigatorVanderbilt University School of Medicine, Department of Pediatrics

4 Previous Clinical Trials

1,208 Total Patients Enrolled

3 Trials studying Asthma

1,118 Patients Enrolled for Asthma

Media Library

High-dose Montelukast Oral Granules Clinical Trial Eligibility Overview. Trial Name: NCT03277170 — Phase 2

Asthma Research Study Groups: Placebo, High-dose Montelukast Oral Granules

Asthma Clinical Trial 2023: High-dose Montelukast Oral Granules Highlights & Side Effects. Trial Name: NCT03277170 — Phase 2

High-dose Montelukast Oral Granules 2023 Treatment Timeline for Medical Study. Trial Name: NCT03277170 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers looking for more participants in this clinical trial?

"According to the official website, this clinical trial is not currently looking for new patients. Although the study was last updated on 11/5/2022, it is still possible that the status could change in the future. There are 354 other trials that are actively recruiting patients right now."

Answered by AI

How can I become a part of this clinical trial?

"Up to 320 young patients, aged 5 to 17 years old, that have a diagnosis of asthma from a medical professional can be admitted into this study. To qualify, these children must also exhibit moderate or severe acute asthma exacerbation and meet the other inclusion criteria."

Answered by AI

Are there similar studies to the one involving high-dose Montelukast Oral Granules?

"As it stands, 22 different clinical trials are studying the effects of high-dose montelukast oral granules. Of those, 6 are in phase 3. The majority of these studies originate from Lexington, Kentucky; however, there are 221 total locations running similar trials."

Answered by AI

What is High-dose Montelukast Oral Granules indicated to treat?

"High-dose Montelukast Oral Granules can be taken to manage exercise-induced bronchospasm, perennial allergic rhinitis (par), and seasonal allergic rhinitis."

Answered by AI

Does this research project restrict eligibility to a certain age group?

"This particular clinical trial is designed for patients aged 5 to 17. In total, there are 131 trials for patients under 18 and 214 for those over 65."

Answered by AI

How many test subjects are enrolled in this experiment?

"Currently, this clinical trial is not admitting patients. The study was first posted on September 1st 2025 and updated November 5th 2022. There are 22 other trials for High-dose Montelukast Oral Granules that are currently recruiting participants as well as 332 other trials concerning asthma in children."

Answered by AI

Has the FDA given high marks to Montelukast Oral Granules?

"While no Phase 2 trials have been run to test the efficacy of High-dose Montelukast Oral Granules, there is some evidence suggesting that it is safe."

Answered by AI

Recent research and studies

Clinical ToxicologyJournal

Adverse Events Are Rare After Single-dose Montelukast Exposures in Children

Arnold, Donald H., Nena Bowman, Theodore F. Reiss, Tina V. Hartert, and Donna L. Seger. 2017. “Adverse Events Are Rare After Single-dose Montelukast Exposures in Children”. Clinical Toxicology. Informa UK Limited. doi:10.1080/15563650.2017.1337123.

clinicaltrials.govStudy

Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations

Donald Hayes Arnold 2025. "Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03277170.