P58 Efficacy of budesonide/formoterol in COPD patients with a post-bronchodilator fev1 50 to <70% of predicted normal: pooled analysis across four phase iii/iv studies
THORAX(2016)
摘要
Background GOLD guidelines have changed from classifying COPD severity using pre-bronchodilator FEV 1 to classifying severity based on post-bronchodilator FEV 1. We therefore conducted a pooled post-hoc analysis of four budesonide/formoterol (Symbicort ® ) Turbuhaler ® trials in COPD (which included patients based on pre-bronchodilator FEV 1 ), assessing efficacy and safety of budesonide/formoterol in the post-bronchodilator FEV 1 50– ® Turbuhaler ® to: ‘symptomatic treatment of patients with COPD with FEV 1 Methods Four randomised, double-blind, active- and/or placebo-controlled, studies in patients with moderate to very severe COPD were analysed. Key study inclusion criteria were pre-bronchodilator FEV 1 ≤50% PN; use of short-acting bronchodilator; ≥1 exacerbation in the past 12 months. Primary endpoints for the analysis were 3-month pre- and 3- and 12-months post-bronchodilator FEV 1 and exacerbation rates at 3- and 12-months. Secondary endpoints included dyspnoea score, total symptom score, reliever medication use, night-time awakening and St George’s Respiratory Questionnaire. Results for the post-bronchodilator FEV 1 50 – Results Of 3787 randomised patients, 832 (22.0%) had post-bronchodilator FEV 1 50 – 1 50 – 1 parameters. The benefit of budesonide/formoterol versus placebo and formoterol on the primary and secondary endpoints were generally consistent between the FEV 1 50 – Conclusions In patients with COPD, the clinical efficacy and safety of budesonide/formoterol compared with placebo and formoterol was consistent between the post-bronchodilator FEV 1 50 – 1
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