Testing high doses of montelukast to help children with severe asthma attacks
Official title: Dose escalation clinical trial of high-dose oral montelukast to inform future RCT in children with acute asthma exacerbations
Funded at Vanderbilt University Medical Center · NIH-10872266 · Data updated 2026-11-12
This study is looking for a better way to help kids with asthma who aren't getting enough relief from their usual medications by testing a higher dose of a medicine called montelukast, to see if it can help ease their symptoms and keep them out of the hospital.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Vanderbilt University Medical Center NIH-funded |
| Lab location | 1 site (Nashville, United States) |
| Project start | July 1, 2023 |
| Project end | June 30, 2026 |
| Funding year | 2024 |
| Award (this year) | $381,026 |
| NIH project number | 5R34HL168301-02 |
| Project ID | NIH-10872266 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are children aged 0-11 years who are experiencing moderate to severe asthma exacerbations and have not responded well to standard treatments.
✕Less likely to help
Patients who do not have asthma or those whose asthma is well-controlled with existing treatments may not benefit from this research.
What this research studies
This research aims to reduce the severity of acute asthma exacerbations in children by testing high doses of montelukast, a medication that blocks leukotrienes, which can cause airway inflammation and constriction. The study will involve children who have not responded adequately to standard treatments like corticosteroids and albuterol. Participants will receive either high-dose montelukast or a placebo in a carefully controlled manner, with doses adjusted based on how well the medication works in their bodies. The goal is to find a treatment that can quickly alleviate symptoms and reduce the need for hospitalization.
Why it matters
Potential benefit: If successful, this research could provide a new, effective treatment option for children experiencing severe asthma attacks, potentially reducing hospital visits.
How similar studies have gone: Previous studies have shown that montelukast can be effective in managing asthma symptoms, but this specific high-dose approach in children is novel and has not been extensively tested.
Where this research is happening
-
Vanderbilt University Medical Center
Nashville, United States Active
Researchers
- Principal investigator: Arnold, Donald Hayes — Vanderbilt University Medical Center
- Study coordinator: Arnold, Donald Hayes
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.