Omalizumab for Asthma Exacerbations in Children
This study is looking at whether a single dose of omalizumab can help prevent asthma flare-ups (exacerbations) in children and teenagers. Omalizumab is a medication that targets IgE, an antibody involved in allergic reactions. Researchers will give either omalizumab or a placebo (an inactive substance) to young people aged 6 to 17 who have persistent asthma and are prone to severe flare-ups, especially during the fall cold season. The main goal is to see how omalizumab affects a specific biomarker called nasal interferon-alpha (IFN-α) shortly after treatment. Participants will be followed for a few months to get their asthma under control before the study intervention.
- Study design
- This is a pilot, randomized controlled trial (RCT) comparing omalizumab to a placebo. It plans to enroll 300 participants over three years.
- What's involved
- Participants will have a 2-6 month run-in period to stabilize their asthma. The study drug or placebo will be given as an injection, and nasal IFN-α will be measured 3-6 days later.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured 3-6 days after injection. The overall follow-up period for each cohort is not fully specified beyond the run-in period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Omalizumab Before Onset of Exacerbations
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- William Sheehan, MD · PRINCIPAL_INVESTIGATOR · Children's National Research Institute
Who to contact
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What this trial measures
- Nasal interferon-α (IFN-α)3-6 day period after injection of study drug/placebo
The change in the amount of nasal IFN-α recovered by nasal fluid absorption between two time points, when study drug/placebo is injected and 3-6 days later