Summary

for people ages 24 months to 47 months (full criteria)
at San Diego, California and other locations
study started
estimated completion

Description

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.

Official Title

Controlling and Preventing Asthma Progression and Severity in Kids

Details

Prevention/ Disease modification of asthma.

Keywords

Asthma Omalizumab

Eligibility

You can join if…

Open to people ages 24 months to 47 months

  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

You CAN'T join if...

  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

Locations

  • Rady Children's Hospital - San Diego not yet accepting patients
    San Diego California 92123 United States
  • Phoenix Children's Hospital accepting new patients
    Phoenix Arizona 85016 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Boston Children’s Hospital
ID
NCT02570984
Phase
Phase 2
Study Type
Interventional
Last Updated