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- W2913477673 abstract "Omalizumab, a monoclonal anti-immunoglobulin (Ig)E antibody, approved for the treatment of moderate-to-severe persistent allergic asthma that remained uncontrolled despite high-dose inhaled corticosteroids (ICS), requiring the use of oral steroids repeatedly and emergency care. The clinical efficacy, safety and tolerability of omalizumab have been demonstrated in children aged 6 to less than 18 years. This was an open-label, parallel-group clinical study with subjects randomized to omalizumab performed in 12 months. We included 126 patients (6 to 17 years of age) with persistent allergic asthma and rhinitis (Total serum IgE level 75 – 1500 UI/mL) who remain uncontrolled despite treatment with high doses of ICS plus a long-acting β2-agonist (LABA). Omalizumab was administered subcutaneously for 12 months. Effectiveness variables considered were change from baseline in exacerbation rate, FEV1, PEF. The quality of life related to asthma was evaluated with PAQLQ and the control with ACQ. Safety and tolerability data were also recorded. 91 patients remaining in the study, treatment with omalizumab group and control group. The baseline and final parameters are described for each of the treatment groups and the difference variables for each parameter (exacerbation were calculated by subtracting the final value from the baseline, in which the changes in omalizumab group are clinically better than those in control group. Asthma attacks decreased in both groups, but in omalizumab group they practically disappear with statistically significant differences. Add-on therapy with omalizumab significantly improved the change from baseline in FEV1, reduces exacerbations, improves control ashma and the quality of life." @default.
- W2913477673 created "2019-02-21" @default.
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- W2913477673 date "2019-02-01" @default.
- W2913477673 modified "2023-09-27" @default.
- W2913477673 title "A Randomized, Open-label, Parallel-group Clinical Study to Evaluate the Efficacy and Safety of Omalizumab in the Treatment of Persistent Moderate and Severe Allergic Asthma and Persistent Allergic Rhinitis in Pediatric Patients 6 to 17 years of age" @default.
- W2913477673 doi "https://doi.org/10.1016/j.jaci.2018.12.288" @default.
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