Omalizumab for Preventing Asthma in Kids
(PARK Trial)

Recruiting in Palo Alto (17 mi)

+12 other locations

Overseen byWanda Phipatanakul, MD. MSc.

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Boston Children's Hospital

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is a randomized, double-blind, placebo controlled trial designed to test whether two years treatment of preschool children aged 2-3 years of age at high risk for asthma with omalizumab (anti-IgE) for two years will prevent the progression to childhood asthma, as reflected by a reduction in the prevalence of active asthma in the Final 12 months during 2 year observation period off study drug.

Eligibility Criteria

This trial is for preschool children aged 2-3 at high risk for asthma, who've had 2-4 wheezing episodes in the past year and a family history of asthma or allergy. They must not have used strong asthma medications recently, had frequent corticosteroid treatments, or have other significant medical conditions.

Inclusion Criteria

I have had 2-4 wheezing episodes in the last year.

A close family member has or had asthma or allergies.

I have been on a stable food allergy treatment not part of a trial for at least 2 months.

+3 more

Exclusion Criteria

I have had more than 4 wheezing episodes in the last year.

I have previously received allergy shots or biologic treatments.

I am currently using a high-level asthma treatment.

+19 more

Participant Groups

The study tests if treating these kids with Omalizumab (anti-IgE) can prevent them from developing childhood asthma compared to a placebo. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real treatment.

2Treatment groups

Active Control

Placebo Group

Group I: ActiveActive Control1 Intervention

omalizumab 0.016 mg/kg/IU total IgE

Group II: PlaceboPlacebo Group1 Intervention

looks like active drug