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Preventing Asthma in High Risk Kids (PARK)

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ClinicalTrials.gov Identifier: NCT02570984
Recruitment Status : Recruiting
First Posted : October 8, 2015
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Wanda Phipatanakul, Boston Children’s Hospital

Tracking Information
First Submitted Date  ICMJE July 28, 2015
First Posted Date  ICMJE October 8, 2015
Last Update Posted Date September 25, 2019
Actual Study Start Date  ICMJE November 27, 2018
Estimated Primary Completion Date November 27, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2017)
  • active asthma diagnosis [ Time Frame: Final 12 months during 2 year observation period off study drug ]
    questionnaire
  • asthma severity [ Time Frame: Final 12 months during 2 year observation period off study drug ]
    questionnaire
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
active asthma diagnosis [ Time Frame: Final 12 months during 2 year observation period off study drug ]
questionnaire
Change History Complete list of historical versions of study NCT02570984 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
  • number of positive new allergic sensitization [ Time Frame: Final 12 months during 2 year observation period off study drug ]
    skin prick test
  • decrease in number of wheezing episodes [ Time Frame: Final 12 months during 2 year observation period off study drug ]
    questionnaires
Original Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
  • number asthma exacerbations [ Time Frame: Final 12 months during 2 year observation period off study drug ]
    questionnaires
  • forced expiratory flow volume in 1 second (FEV1) [ Time Frame: during 2 year observation period ]
    lung function
  • symptom free days [ Time Frame: every month during 2 year observation period ]
    questionnaire
  • number of positive allergic sensitization [ Time Frame: final year during 2 year observation period ]
    questionnaire
  • number of asthma exacerbations [ Time Frame: during 2 year treatment ]
    questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preventing Asthma in High Risk Kids
Official Title  ICMJE Controlling and Preventing Asthma Progression and Severity in Kids
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.
Detailed Description Prevention/ Disease modification of asthma.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: Omalizumab
    anti-ige injection
    Other Name: Xolair
  • Drug: Placebo
    placebo comparator arm, injection similar to active
    Other Name: placebo arm
Study Arms  ICMJE
  • Active Comparator: Active
    omalizumab 0.016 mg/kg/IU total IgE
    Intervention: Drug: Omalizumab
  • Placebo Comparator: Placebo
    looks like active drug
    Intervention: Drug: Placebo
Publications * 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 7, 2015)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 27, 2025
Estimated Primary Completion Date November 27, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 24 Months to 47 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02570984
Other Study ID Numbers  ICMJE IRB-P00019640
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wanda Phipatanakul, Boston Children’s Hospital
Study Sponsor  ICMJE Boston Children’s Hospital
Collaborators  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE
Principal Investigator: Wanda Phipatanakul, MD, MS Boston Children’s Hospital
PRS Account Boston Children’s Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP