Preventing Asthma in High Risk Kids (PARK)

Controlling and Preventing Asthma Progression and Severity in Kids

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: Omalizumab; Drug: Placebo

Detailed Description

Prevention/ Disease modification of asthma.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hospital
  • California
    • San Diego, California, United States, 92123
      • Rady Children's Hospital - San Diego
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Childrens Hospital Colorado
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Connecticut Children's Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital of Chicago
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University/Riley Children's Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital/Baylor College of Medicine
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 3 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. 24-47 months of age at randomization
3. 2-4 wheezing episodes in the past year
4. positive allergy to aeroallergen
5. first degree relative with history or current diagnosis of asthma or allergy
6. 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:

1. >4 episodes of wheezing in the past year
2. Use of Step 5 or Step 6 therapy (ICS plus LABA ) at the time of enrollment (Visit 0).
3. Need for systemic corticosteroids or a hospitalization for respiratory symptoms within four weeks prior to screening.
4. Three or more courses of systemic corticosteroids for wheezing illnesses in the last year
5. 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
6. More than four days of albuterol treatment (for symptoms) in the past two weeks
7. More than one night of symptoms of wheezing, or tightness in the chest or cough causing sleep disruption in the past two weeks
8. More than one night of albuterol treatment (for symptoms) in the past two weeks
9. Prematurity (<34 weeks gestation)
10. Need for oxygen for more than 5 days in the neonatal period
11. History of intubation or mechanical ventilation for respiratory illness
12. 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
13. Expecting to relocate within 4 years of study initiation to a place which would make in-person clinical visits impossible
14. Deemed unable to adhere to study activities
15. Prior aeroallergen immunotherapy or use of biologics including anti-IgE
16. Prior IVIG or systemic immunosuppressant other than corticosteroids
17. History of hypoxic seizures during a wheezing episode
18. Total IgE outside of the omalizumab dosing range.
19. Enrolled in any clinical medication trial within the past 30 days.
20. With platelet counts < 150 x 109/L at the Screening Visit (V0)
21. 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.
22. History of severe anaphylactic/anaphylactoid reactions from any cause

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; omalizumab 0.016 mg/kg/IU total IgE	Drug: Omalizumab; anti-ige injection; Other Names: Xolair
Placebo Comparator: Placebo; looks like active drug	Drug: Placebo; placebo comparator arm, injection similar to active; Other Names: placebo arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
active asthma diagnosis	questionnaire	Final 12 months during 2 year observation period off study drug
asthma severity	questionnaire	Final 12 months during 2 year observation period off study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of positive new allergic sensitization	skin prick test	Final 12 months during 2 year observation period off study drug
decrease in number of wheezing episodes	questionnaires	Final 12 months during 2 year observation period off study drug

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Wanda Phipatanakul, MD, MS, Boston Children's Hospital

Publications and helpful links

General Publications

• Phipatanakul W, Mauger DT, Guilbert TW, Bacharier LB, Durrani S, Jackson DJ, Martinez FD, Fitzpatrick AM, Cunningham A, Kunselman S, Wheatley LM, Bauer C, Davis CM, Geng B, Kloepfer KM, Lapin C, Liu AH, Pongracic JA, Teach SJ, Chmiel J, Gaffin JM, Greenhawt M, Gupta MR, Lai PS, Lemanske RF, Morgan WJ, Sheehan WJ, Stokes J, Thorne PS, Oettgen HC, Israel E; PARK Study Team. Preventing asthma in high risk kids (PARK) with omalizumab: Design, rationale, methods, lessons learned and adaptation. Contemp Clin Trials. 2021 Jan;100:106228. doi: 10.1016/j.cct.2020.106228. Epub 2020 Nov 24.
• Martinez FD. Childhood Asthma Inception and Progression: Role of Microbial Exposures, Susceptibility to Viruses and Early Allergic Sensitization. Immunol Allergy Clin North Am. 2019 May;39(2):141-150. doi: 10.1016/j.iac.2018.12.001.

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2018
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: July 28, 2015
• First Submitted That Met QC Criteria: October 7, 2015
• First Posted (Estimated): October 8, 2015

Study Record Updates

• Last Update Posted (Actual): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Omalizumab
• Other Study ID Numbers: IRB-P00019640

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No