• Lu Chen and Yanping Chen.
• Department of Respiratory, Hunan Children's Hospital, Hunan, China.
• Medicine (Baltimore). 2021 Jun 4; 100 (22): e26155e26155.

BackgroundIt is still controversial in the current literature whether omalizumab is beneficial for children with asthma. Given that there is no high-quality meta-analysis to incorporate existing evidence, the purpose of this protocol is to design a systematic review and meta-analysis of the level I evidence to ascertain whether omalizumab is beneficial and safe for children with asthma.MethodsThe systematic literature review is structured to adhere to Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. The following search terms will be used in PUBMED, Scopus, EMBASE, and Cochrane Library databases on June, 2021, as the search algorithm: (omalizumab) AND (asthma) AND (children). The primary outcome is the long-term safety and tolerability of omalizumab. The other outcomes include asthma control, quality of life, use of asthma controller medications, and spirometry measurements and emergency room visits due to asthma, and serum trough concentrations of omalizumab, free and total immunoglobulin E measured. Review Manager software (v 5.3; Cochrane Collaboration) will be used for the meta-analysis.ResultsThe review will add to the existing literature by showing compelling evidence and improved guidance in clinic settings.Registration Number10.17605/OSF.IO/G6N3P.Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.

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