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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 hours

Awards & highlights

TEAM Trial Summary

This trial will test whether high-dose oral montelukast can improve asthma symptoms in children who haven't responded to standard treatments.

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.Check my eligibility

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.See study design

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.

TEAM Trial 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.

TEAM Trial 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

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

Primary outcome measures

Montelukast plasma level

Secondary outcome measures

Airway resistance by impulse oscillometry (IOS)

Change of Acute Asthma Intensity Research Score

TEAM 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

672,103 Total Patients Enrolled

13 Trials studying Asthma

4,695 Patients Enrolled for Asthma

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

4 Previous Clinical Trials

1,438 Total Patients Enrolled

4 Trials studying Asthma

1,438 Patients Enrolled for Asthma

Media Library

Albuterol (Bronchodilator) Clinical Trial Eligibility Overview. Trial Name: NCT05819541 — Phase 2

Asthma Research Study Groups: High-dose oral montelukast plus standard treatment, Identical placebo plus standard treatment

Asthma Clinical Trial 2023: Albuterol Highlights & Side Effects. Trial Name: NCT05819541 — Phase 2

Albuterol (Bronchodilator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05819541 — Phase 2

Frequently Asked Questions

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

Does the age restriction for this medical experiment cap out at eighty-five years old?

"Eligible participants in the trial must be between 4 and 12 years old."

Answered by AI

Might I be accepted to partake in this experiment?

"This asthma study seeks 90 participants aged between 4 and 12 years old. Essential for enrolment is a doctor's diagnosis of the condition, as well as compliance with other eligibility criteria."

Answered by AI

Is there any opportunity for additional volunteers to join this research endeavor?

"Per the information posted on clinicaltrials.gov, this particular medical study is not presently enrolling any participants. The trial was originally listed on July 1st 2023 and most recently revised April 5th of the same year. Nonetheless, there are 3 other trials that are actively seeking patients at present."

Answered by AI

What implications should be considered in adopting a high-dose montelukast regimen as part of the standard therapeutic approach?

"The safety of high-dose oral montelukast plus standard treatment was judged to be a 2, as the trial is only in Phase 2; while there has been some evidence supporting its safety, no information exists on its efficacy."

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

Treating Exacerbations of Asthma With Oral Montelukast in Children

Donald Hayes Arnold 2023. "Treating Exacerbations of Asthma With Oral Montelukast in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05819541.