← Back to Search

Monoclonal Antibodies

Omalizumab for Preventing Asthma in Kids (PARK Trial)

Phase 2

Waitlist Available

Led By Wanda Phipatanakul, MD, MS

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

24-47 months of age at randomization

2-4 wheezing episodes in the past year

Must not have

>4 episodes of wheezing in the past year

Prior aeroallergen immunotherapy or use of biologics including anti-IgE

Timeline

Screening 3 weeks

Treatment Varies

Follow Up final 12 months during 2 year observation period off study drug

Summary

This trial is testing whether a drug can prevent asthma in kids aged 2-3. It's double-blind, meaning neither the participants nor the researchers know who's receiving the drug or the placebo.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Omalizumab may cause injection site reactions, viral infections like colds or ear infection, headaches, and possibly severe allergic reactions. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 2 and 4 years old.

Select...

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

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have previously received allergy shots or biologic treatments.

Select...

I am currently using a high-level asthma treatment.

Select...

I've had wheezing or coughing at night that disturbed my sleep more than once in the last two weeks.

Select...

I needed oxygen for more than 5 days after birth.

Select...

My IgE levels are not within the range for omalizumab treatment.

Select...

I have had seizures caused by low oxygen during asthma attacks.

Select...

I do not have major health issues like cystic fibrosis or a history of tuberculosis.

Select...

I have not taken IVIG or immunosuppressants, except for corticosteroids.

Select...

I've used albuterol for symptoms more than four days in the last two weeks.

Select...

I have been on a breathing machine for lung problems before.

Select...

I've had symptoms like wheezing or chest tightness that limited my activities in the last two weeks.

Select...

I've taken steroids for wheezing more than 3 times last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ final 12 months during 2 year observation period off study drug

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~final 12 months during 2 year observation period off study drug

This trial's timeline: 3 weeks for screening, Varies for treatment, and final 12 months during 2 year observation period off study drug for reporting.