Purpose

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.

Condition

Eligibility

Eligible Ages
Between 24 Months and 47 Months
Eligible Genders
All
Accepts Healthy Volunteers
No

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. positive allergy to aeroallergen
  4. 2-4 wheezing episodes past year
  5. first degree relative with history or current diagnosis of asthma or allergy

Exclusion Criteria

  1. >4 episodes of wheezing in the past year
  2. Use of inhaled steroids or inhaled steroids plus long acting beta agonists for respiratory symptoms for greater than 4 months in the past year
  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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Children's National and nearby locations

Children's National Medical Center
Washington, District of Columbia 20010
Contact:
Alicia Mathis
202-476-4698
ANewcome@childrensnational.org

More Details

NCT ID
NCT02570984
Status
Recruiting
Sponsor
Boston Children’s Hospital

Study Contact

Wanda Phipatanakul, MD, MS
857-218-5336
wanda.phipatanakul@childrens.harvard.edu

Detailed Description

Prevention/ Disease modification of asthma.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.