Clinical trial NCT02570984: Preventing Asthma in High Risk Kids
Official title: Controlling and Preventing Asthma Progression and Severity in Kids
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2015-10-08
Enrollment: 200
Sex: ALL
Minimum age (years): 24
Maximum age (years): 47
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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. 2-4 wheezing episodes in the past year
4. positive allergy to aeroallergen
5. first degree relative with history or current diagnosis of asthma or allergy
6. If is participating in a food immunotherapy treatment that is not part of a clinical trial, has been on an established maintenance regimen implemented continuously for a minimum of 2 months.

Exclusion Criteria:

1. \>4 episodes of wheezing in the past year
2. Use of Step 5 or Step 6 therapy (ICS plus LABA ) at the time of enrollment (Visit 0).
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

Primary outcomes:
measure: active asthma diagnosis
timeFrame: Final 12 months during 2 year observation period off study drug
measure: asthma severity
timeFrame: Final 12 months during 2 year observation period off study drug
Secondary outcomes:
measure: number of positive new allergic sensitization
timeFrame: Final 12 months during 2 year observation period off study drug
measure: decrease in number of wheezing episodes
timeFrame: Final 12 months during 2 year observation period off study drug
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: San Diego
country: United States
facility: Rady Children's Hospital - San Diego
state: California
city: Aurora
country: United States
facility: Childrens Hospital Colorado
state: Colorado
city: Hartford
country: United States
facility: Connecticut Children's Hospital
state: Connecticut
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University/Riley Children's Hospital
state: Indiana
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Houston
country: United States
facility: Texas Children's Hospital/Baylor College of Medicine
state: Texas
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Boston Children's Hospital
name: Wanda Phipatanakul, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Phipatanakul W, Mauger DT, Guilbert TW, Bacharier LB, Durrani S, Jackson DJ, Martinez FD, Fitzpatrick AM, Cunningham A, Kunselman S, Wheatley LM, Bauer C, Davis CM, Geng B, Kloepfer KM, Lapin C, Liu AH, Pongracic JA, Teach SJ, Chmiel J, Gaffin JM, Greenhawt M, Gupta MR, Lai PS, Lemanske RF, Morgan WJ, Sheehan WJ, Stokes J, Thorne PS, Oettgen HC, Israel E; PARK Study Team. Preventing asthma in high risk kids (PARK) with omalizumab: Design, rationale, methods, lessons learned and adaptation. Contemp Clin Trials. 2021 Jan;100:106228. doi: 10.1016/j.cct.2020.106228. Epub 2020 Nov 24.
citation: 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.