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Your Yourlocation: Home > Double-blind, parallel-group controlled study of tiotropium bromide(136310-93-5) and salmeterol

This study was a 12-month, double-blind, parallel-group controlled multinational study (WISDOM) of 2485 patients with COPD with a history of acute exacerbations. During the first 6 weeks of the study, all patients were treated with tiotropium bromide(136310-93-5)(18 μg daily for 1 day), salmeterol (50 μg daily for 2 doses), fluticasone propionate 500μg daily, 2 suction).

Six weeks later, all patients were randomized to receive triple therapy in a 1:1 ratio or step-by-step discontinuation of fluticasone propionate (stepwise reduction from 1000 μg to 500 μg, then 200 μg every 6 weeks) Replacement with placebo). The primary end point was the first episode of moderate to severe COPD. And to monitor lung function, health status and dyspnea.

The first acute exacerbation of severe COPD in the ICS group was achieved with a 95% upper confidence limit of 1.20 for the default noninferiority criteria, with a hazard ratio of 1.06, compared with the continued use of ICS. After 18 weeks of treatment (complete cessation of glucocorticoid therapy), the mean reduction in FEV1 trough correction after discontinuation of the ICS group was 38 ml higher than in the continued ICS group; after 52 weeks of treatment, the change was similar between the two groups 43 ml). The dyspnoea did not change in the ICS group, and the change in health status was small.

The results show that patients with severe COPD treated with tiotropium bromide(136310-93-5) and salmeterol have a similar risk of developing moderate to severe acute exacerbations with discontinued inhaled corticosteroids and continued glucocorticoid therapy. However, in the final step of cessation of glucocorticoid, COPD patients with greater decline in lung function.

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