Using high-dose oral montelukast to treat asthma exacerbations in children
Dose Escalation Clinical Trial of High-dose Oral Montelukast to Inform Future RCT in Children With Acute Asthma Exacerbations
PHASE2 · Vanderbilt University Medical Center · NCT05819541
This study is testing whether high doses of a medication called montelukast can help children aged 4 to 12 who are having serious asthma attacks feel better after using their inhalers.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 4 Years to 12 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center (other) |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05819541 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine the optimal dosage of high-dose oral montelukast for children aged 4 to 12 experiencing moderate to severe asthma exacerbations after initial treatment with inhaled albuterol. The study will utilize an adaptive, double-masked randomized controlled trial design, where participants will receive either montelukast or a placebo, with doses adjusted based on pharmacokinetic modeling. The primary goal is to achieve a peak plasma concentration of montelukast that is effective in reducing asthma symptoms, as measured by the Acute Asthma Intensity Research Score (AAIRS).
Who should consider this trial
Good fit: Ideal candidates are children aged 4 to 12 years with doctor-diagnosed asthma who present with moderate to severe exacerbations.
Not a fit: Patients with acute or chronic liver disease, allergies to montelukast, or significant neuropsychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for children suffering from acute asthma exacerbations.
How similar studies have performed: Previous studies have shown that intravenous montelukast can rapidly improve lung function in adults, suggesting potential success for high-dose oral montelukast in children.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Nashville, Tennessee
- Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States (RECRUITING)
Study contacts
- Principal investigator: Donald H Arnold, MD, MPH — Vanderbilt University School of Medicine
- Study coordinator: Donald H Arnold, MD, MPH
- Email: don.arnold@vumc.org
- Phone: 16155790516
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Status Asthmaticus