Preventing Asthma in High Risk Kids (PARK)

  • STATUS
    Recruiting
  • End date
    Nov 27, 2025
  • participants needed
    200
  • sponsor
    Boston Children's Hospital
Updated on 23 March 2022
wheezing
childhood asthma
anti-ige
omalizumab

Summary

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.

Description

Prevention/ Disease modification of asthma.

Details
Condition Asthma
Treatment Placebo, omalizumab
Clinical Study IdentifierNCT02570984
SponsorBoston Children's Hospital
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Parent/guardian must be able to understand and provide signed and dated written informed consent; he/she must also be able to communicate with study staff
24-47 months of age at randomization
2-4 wheezing episodes in the past year
positive allergy to aeroallergen
first degree relative with history or current diagnosis of asthma or allergy
If is participating in a food immunotherapy treatment that is not part of a clinical trial, has been on an established maintenance regimen implemented continuously for a minimum of 2 months

Exclusion Criteria

>4 episodes of wheezing in the past year
Use of Step 5 or Step 6 therapy (ICS plus LABA ) at the time of enrollment (Visit 0)
Need for systemic corticosteroids or a hospitalization for respiratory symptoms within four weeks prior to screening
Three or more courses of systemic corticosteroids for wheezing illnesses in the last year
More than four days of symptoms of wheezing, or tightness in the chest or cough in the past two weeks causing at least minimal limitation of activity
More than four days of albuterol treatment (for symptoms) in the past two weeks
More than one night of symptoms of wheezing, or tightness in the chest or cough causing sleep disruption in the past two weeks
More than one night of albuterol treatment (for symptoms) in the past two weeks
Prematurity (<34 weeks gestation)
Need for oxygen for more than 5 days in the neonatal period
History of intubation or mechanical ventilation for respiratory illness
Other significant medical conditions, including: major congenital anomalies, cystic fibrosis, chronic pulmonary diseases, bronchopulmonary dysplasia, thoracic surgery, history of tuberculosis, immunodeficiency (primary or secondary), seizure disorders
Expecting to relocate within 4 years of study initiation to a place which would make in-person clinical visits impossible
Deemed unable to adhere to study activities
Prior aeroallergen immunotherapy or use of biologics including anti-IgE
Prior IVIG or systemic immunosuppressant other than corticosteroids
History of hypoxic seizures during a wheezing episode
Total IgE outside of the omalizumab dosing range
Enrolled in any clinical medication trial within the past 30 days
With platelet counts < 150 x 109/L at the Screening Visit (V0)
Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or may impact the quality or interpretation of the data obtained from the study
History of severe anaphylactic/anaphylactoid reactions from any cause
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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