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High-Dose Montelukast for Childhood Asthma

Nashville, TN

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

Must not have

Chronic lung disease other than asthma

Use of noninvasive ventilation at home

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8-hours after treatment with montelukast or placebo

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.

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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.

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Exclusion Criteria

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

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I have a long-term lung condition that is not asthma.

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I use a breathing aid at home that doesn't require surgery.

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I take medication for acid reflux.

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I have previously used an LTRA medication like montelukast.

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I have liver disease.

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I have tuberculosis.

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I need help right away to breathe.

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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

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

Primary study objectives

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

Secondary study objectives

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)

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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 / 10Eligibility criteria met