Can a shot stop asthma before it starts? new trial tests omalizumab in toddlers

NCT ID NCT02570984

First seen Jun 27, 2026 ยท Last updated Jun 27, 2026

Summary

This study tests whether giving omalizumab (Xolair) to 2-3 year olds at high risk for asthma for two years can prevent the disease from developing. 200 children are enrolled in a double-blind, placebo-controlled trial. After treatment, they are monitored for another two years to see if they have fewer asthma symptoms and allergies.

What this could mean

Our plain-language read of the trial. This is informational only โ€” not medical advice or a prediction.

Active substance
omalizumab (Xolair)
What this could lead to
If successful, this could point toward a way to prevent asthma from developing in high-risk children.
What could go wrong
This is a Phase 2 trial with 200 kids, so results are preliminary. The benefit may not be large or lasting, and omalizumab injections can cause allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010, United States

  • Childrens Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Connecticut Children's Hospital

    Hartford, Connecticut, 06106, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Indiana University/Riley Children's Hospital

    Indianapolis, Indiana, 46202, United States

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016, United States

  • Rady Children's Hospital - San Diego

    San Diego, California, 92123, United States

  • Texas Children's Hospital/Baylor College of Medicine

    Houston, Texas, 77030, United States

  • University of Wisconsin

    Madison, Wisconsin, 53792, United States

  • Washington University

    St Louis, Missouri, 63110, United States

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