Preventing Asthma in High Risk Kids

NCT ID: NCT02570984

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-27
• Study Completion Date: 2028-03-31

Brief 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.

Detailed Description

Prevention/ Disease modification of asthma.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Active

omalizumab 0.016 mg/kg/IU total IgE

Group Type: ACTIVE_COMPARATOR

Omalizumab

Intervention Type: DRUG

anti-ige injection

Placebo

looks like active drug

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo comparator arm, injection similar to active

Interventions

Omalizumab

anti-ige injection

Intervention Type: DRUG

Placebo

placebo comparator arm, injection similar to active

Intervention Type: DRUG

Other Intervention Names

Xolair; placebo arm

Eligibility Criteria

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

• Minimum Eligible Age: 24 Months
• Maximum Eligible Age: 47 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wanda Phipatanakul

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wanda Phipatanakul, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

University of Wisconsin

Madison, Wisconsin, United States

Phoenix Children's Hospital

Phoenix, Arizona, United States

Rady Children's Hospital - San Diego

San Diego, California, United States

Childrens Hospital Colorado

Aurora, Colorado, United States

Connecticut Children's Hospital

Hartford, Connecticut, United States

Children's National Medical Center

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

Emory University

Atlanta, Georgia, United States

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

Chicago, Illinois, United States

Indiana University/Riley Children's Hospital

Indianapolis, Indiana, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Texas Children's Hospital/Baylor College of Medicine

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33242697 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30954166 (View on PubMed)

Other Identifiers

U01AI179563

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-P00019640

Identifier Type: -

Identifier Source: org_study_id