Preventing Asthma in High Risk Kids

Therapuetic Areas:Pulmonary / Respiratory Diseases
Age Range:Any
Start Date:November 27, 2018
End Date:November 27, 2025
Contact:Wanda Phipatanakul, MD, MS

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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.

Prevention/ Disease modification of asthma.

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

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
We found this trial at
Saint Louis, Missouri 63110
Saint Louis, MO
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
Atlanta, GA
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
Cincinnati, OH
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Andrew Liu, MD
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
Aurora, CO
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
Boston, MA
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Hartford, Connecticut 06106
Hartford, CT
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
Madison, WI
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Tucson, Arizona 85721
(520) 621-2211
University of Arizona The University of Arizona is a premier, public research university. Established in...
Tucson, AZ
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