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Preventing Asthma in High Risk Kids (PARK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02570984
Recruitment Status : Recruiting
First Posted : October 8, 2015
Last Update Posted : October 28, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Wanda Phipatanakul, Boston Children’s Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Omalizumab Drug: Placebo Phase 2

Detailed Description:
Prevention/ Disease modification of asthma.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Controlling and Preventing Asthma Progression and Severity in Kids
Actual Study Start Date : November 27, 2018
Estimated Primary Completion Date : November 27, 2023
Estimated Study Completion Date : November 27, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Omalizumab

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Active
omalizumab 0.016 mg/kg/IU total IgE
 Drug: Omalizumab
anti-ige injection
Other Name: Xolair
Placebo Comparator: Placebo
looks like active drug
 Drug: Placebo
placebo comparator arm, injection similar to active
Other Name: placebo arm


Outcome Measures
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Primary Outcome Measures :
  1. active asthma diagnosis [ Time Frame: Final 12 months during 2 year observation period off study drug ]
    questionnaire

  2. asthma severity [ Time Frame: Final 12 months during 2 year observation period off study drug ]
    questionnaire


Secondary Outcome Measures :
  1. number of positive new allergic sensitization [ Time Frame: Final 12 months during 2 year observation period off study drug ]
    skin prick test

  2. decrease in number of wheezing episodes [ Time Frame: Final 12 months during 2 year observation period off study drug ]
    questionnaires


Eligibility Criteria
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Ages Eligible for Study:   24 Months to 47 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570984


Contacts
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Contact: Wanda Phipatanakul, MD, MS 857-218-5336 wanda.phipatanakul@childrens.harvard.edu
Contact: Amparito Cunningham, MD, MPH 857-218-5336 asthma@childrens.harvard.edu

Locations
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United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Cindy Bauer, MD.    602-933-3666    cbauer@phoenixchildrens.com   
Contact: Heather Shearer, BSN, RN.    602-933-0865    HShearer@phoenixchildrens.com   
Principal Investigator: Cindy Bauer, MD.         
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Contact: Fernando Martinez, MD         
United States, California
Rady Children's Hospital - San Diego Recruiting
San Diego, California, United States, 92123
Contact: Bob Geng, MD    314-608-8693    bgeng@ucsd.edu   
Contact: Diba Mortazavi    858-966-1700 ext 3422    dmortazavi@ucsd.edu   
Principal Investigator: Bob Geng, MD.         
United States, Colorado
Childrens Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Childrens H Colorado         
Contact: Darci Anderson    720-777-0577    Darci.anderson@childrenscolorado.org   
Principal Investigator: Andrew Liu, MD         
United States, Connecticut
Connecticut Children's Hospital Recruiting
Hartford, Connecticut, United States, 06106
Contact: Tregony Simoneau, MD         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Alicia Mathis    202-476-4698    ANewcome@childrensnational.org   
Contact: Taqwua El-Hussein       telhussein@childrensnational.org   
Principal Investigator: Stephen Teach, MD. MPH.         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Anne Fitzpatrick, PhD, NP         
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Jacqueline Pongracic, MD.    312-227-6010    JPongracic@luriechildrens.org   
Contact: Michelle Catalano, BS,LPN,CCRP    (312) 227-6455    MCatalano@luriechildrens.org   
Principal Investigator: Jacqueline Pongracic, MD.         
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Amparito Cunningham, MD. MPH.    857-218-5336    amparito.cunningham@childrens.harvard.edu   
Principal Investigator: Wanda Phipatanakul, MD. MSc.         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Leonard Bacharier, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Alisha Hartman, BS    513-636-1882    Alisha.Hartmann@cchmc.org   
Principal Investigator: Theresa Guilbert, MD.         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Daniel Jackson, MD         
Sponsors and Collaborators
Boston Children’s Hospital
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Wanda Phipatanakul, MD, MS Boston Children’s Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wanda Phipatanakul, Professor of Pediatrics, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02570984    
Other Study ID Numbers: IRB-P00019640
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents