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• W4386819346 abstract "Severe asthma is associated with airway inflammation and airway obstruction. In the phase 3 NAVIGATOR study, tezepelumab treatment significantly improved pre-bronchodilator forced expiratory volume in 1 s (FEV1) compared with placebo in patients with severe, uncontrolled asthma. This analysis assessed the effect of tezepelumab versus placebo on additional lung function parameters in patients from NAVIGATOR.NAVIGATOR was a multicenter, randomized, double-blind, placebo-controlled study. Patients (12-80 years old) receiving medium- or high-dose inhaled corticosteroids and at least one additional controller medication, with or without oral corticosteroids, were randomized 1:1 to tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks. Changes from baseline to week 52 in pre-bronchodilator FEV1, post-bronchodilator FEV1, forced vital capacity (FVC), pre-bronchodilator FEV1/FVC ratio, pre-bronchodilator forced expiratory flow between 25 and 75% of vital capacity (FEF25-75), and morning and evening peak expiratory flow (PEF) were assessed.Tezepelumab treatment improved all evaluated lung function parameters over 52 weeks compared with placebo [least-squares mean difference (95% confidence interval): pre-bronchodilator FEV1, 0.13 (0.08, 0.18) L; post-bronchodilator FEV1, 0.12 (0.07, 0.16) L; FVC, 0.13 (0.07, 0.19) L; FEV1/FVC ratio, 2.06% (1.22%, 2.90%); FEF25-75, 0.13 (0.07, 0.19) L/s; morning PEF, 16.6 (8.1, 25.1) L/min; and evening PEF, 14.9 (6.3, 23.4) L/min]. Improvements were observed as early as weeks 1-2 and were maintained over 52 weeks. Greater improvements in lung function compared with placebo were observed in patients with a disease duration of less than 20 years, those with baseline post-bronchodilator FEV1 reversibility of at least 20%, and in patients with a baseline post-bronchodilator FEV1/FVC ratio of less than 0.7.These findings further support the benefits of tezepelumab treatment in improving airflow limitation in patients with severe, uncontrolled asthma.NAVIGATOR (NCT03347279)." @default.
• W4386819346 created "2023-09-19" @default.
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• W4386819346 date "2023-09-19" @default.
• W4386819346 modified "2023-10-15" @default.
• W4386819346 title "Effect of Tezepelumab on Lung Function in Patients With Severe, Uncontrolled Asthma in the Phase 3 NAVIGATOR Study" @default.
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• W4386819346 doi "https://doi.org/10.1007/s12325-023-02659-y" @default.
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• W4386819346 hasPublicationYear "2023" @default.
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