Preventing Asthma in High Risk Kids

NCT02570984 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IRB-P00019640U01AI179563
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 13

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• number of positive new allergic sensitization

  Final 12 months during 2 year observation period off study drug

• decrease in number of wheezing episodes

  Final 12 months during 2 year observation period off study drug

Study Arms (2)

Active

ACTIVE COMPARATOR

omalizumab 0.016 mg/kg/IU total IgE

Drug: Omalizumab

Placebo

PLACEBO COMPARATOR

looks like active drug

Drug: Placebo

Interventions

Omalizumab DRUG

anti-ige injection

Also known as: Xolair

Active

Placebo DRUG

placebo comparator arm, injection similar to active

Also known as: placebo arm

Placebo

Eligibility Criteria

• Age: 24 Months - 47 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• months of age at randomization
• 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.

You may not qualify if:

• \>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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (13)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Rady Children's Hospital - San Diego

San Diego, California, 92123, United States

Location

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Connecticut Children's Hospital

Hartford, Connecticut, 06106, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

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

Chicago, Illinois, 60611, United States

Location

Indiana University/Riley Children's Hospital

Indianapolis, Indiana, 46202, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Texas Children's Hospital/Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• 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.

  PMID: 33242697 DERIVED

• 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.

  PMID: 30954166 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Wanda Phipatanakul, MD, MS

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: October 8, 2015
• Study Start: November 27, 2018
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

US (13)