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Randomized Controlled Trial
. 2021 Jan:100:106228.
doi: 10.1016/j.cct.2020.106228. Epub 2020 Nov 24.

Preventing asthma in high risk kids (PARK) with omalizumab: Design, rationale, methods, lessons learned and adaptation

Wanda Phipatanakul  1 , David T Mauger  2 , Theresa W Guilbert  3 , Leonard B Bacharier  4 , Sandy Durrani  3 , Daniel J Jackson  5 , Fernando D Martinez  6 , Anne M Fitzpatrick  7 , Amparito Cunningham  8 , Susan Kunselman  2 , Lisa M Wheatley  9 , Cindy Bauer  10 , Carla M Davis  11 , Bob Geng  12 , Kirsten M Kloepfer  13 , Craig Lapin  14 , Andrew H Liu  15 , Jacqueline A Pongracic  16 , Stephen J Teach  17 , James Chmiel  9 , Jonathan M Gaffin  18 , Matthew Greenhawt  15 , Meera R Gupta  11 , Peggy S Lai  19 , Robert F Lemanske  5 , Wayne J Morgan  6 , William J Sheehan  17 , Jeffrey Stokes  4 , Peter S Thorne  20 , Hans C Oettgen  21 , Elliot Israel  22 ; PARK Study Team
Collaborators, Affiliations
Randomized Controlled Trial

Preventing asthma in high risk kids (PARK) with omalizumab: Design, rationale, methods, lessons learned and adaptation

Wanda Phipatanakul et al. Contemp Clin Trials. 2021 Jan.

Abstract

Asthma remains one of the most important challenges to pediatric public health in the US. A large majority of children with persistent and chronic asthma demonstrate aeroallergen sensitization, which remains a pivotal risk factor associated with the development of persistent, progressive asthma throughout life. In individuals with a tendency toward Type 2 inflammation, sensitization and exposure to high concentrations of offending allergens is associated with increased risk for development of, and impairment from, asthma. The cascade of biological responses to allergens is primarily mediated through IgE antibodies and their production is further stimulated by IgE responses to antigen exposure. In addition, circulating IgE impairs innate anti-viral immune responses. The latter effect could magnify the effects of another early life exposure associated with increased risk of the development of asthma - viral infections. Omalizumab binds to circulating IgE and thus ablates antigen signaling through IgE-related mechanisms. Further, it has been shown restore IFN-α response to rhinovirus and to reduce asthma exacerbations during the viral season. We therefore hypothesized that early blockade of IgE and IgE mediated responses with omalizumab would prevent the development and reduce the severity of asthma in those at high risk for developing asthma. Herein, we describe a double-blind, placebo-controlled trial of omalizumab in 2-3 year old children at high risk for development of asthma to prevent the development and reduce the severity of asthma. We describe the rationale, methods, and lessons learned in implementing this potentially transformative trial aimed at prevention of asthma.

Trial registration: ClinicalTrials.gov NCT02570984.

Keywords: Allergies; Anti-IgE; Asthma; Atopic march; Omalizumab; Prevention.

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Figures

Fig 1.
Fig 1.
Relative risk for omalizumab compared to placebo.
Fig 2.
Fig 2.
Reduction in CASI score among those diagnosed with asthma.
See this image and copyright information in PMC

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