Preventing Asthma in High Risk Kids

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.

Timeline

Start

2018-11-27

Primary completion

2028-01-31

Completion

2028-03-31

Publications

• 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.
• 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.

Drugs

Indications