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

Background GOLD guidelines have changed from classifying COPD severity using pre-bronchodilator FEV1 to classifying severity based on post-bronchodilator FEV1. We therefore conducted a pooled post-hoc analysis of four budesonide/formoterol (Symbicort®) Turbuhaler® trials in COPD (which included patients based on pre-bronchodilator FEV1), assessing efficacy and safety of budesonide/formoterol in the post-bronchodilator FEV150– 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 FEV1 ≤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 FEV1 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 FEV150 – Results Of 3787 randomised patients, 832 (22.0%) had post-bronchodilator FEV150 – Conclusions In patients with COPD, the clinical efficacy and safety of budesonide/formoterol compared with placebo and formoterol was consistent between the post-bronchodilator FEV1 50 –