Background GOLD guidelines have changed from classifying COPD severity using pre-bronchodilator FEV₁ 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 FEV₁), assessing efficacy and safety of budesonide/formoterol in the post-bronchodilator FEV₁50– <70% of predicted normal (PN) subpopulation versus the all-patient population. This analysis supported the EU label change for Symbicort^® Turbuhaler^® to: ‘symptomatic treatment of patients with COPD with FEV₁ < 70% PN (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy’.

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 – <70% PN subpopulation were compared with the all-patient population.

Results Of 3787 randomised patients, 832 (22.0%) had post-bronchodilator FEV₁50 – <70% PN. Baseline characteristics of the FEV₁50 – <70% subpopulation and the all-patient population were similar, except for baseline FEV₁ parameters. The benefit of budesonide/formoterol versus placebo and formoterol on the primary and secondary endpoints were generally consistent between the FEV₁50 – <70% subpopulation and the all-patient population across all four studies and in the pooled analysis (Figure 1). No new safety signals were identified.

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 – <70% PN subpopulation and the all-patient population, confirming the positive benefit/risk ratio in COPD patients with a post-bronchodilator FEV₁ <70% PN and a history of exacerbations.

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Abstract P58 Figure 1

Coparison of FEV₁ (A) and exacerbation rates (B) with budesonide/formoterol treatment vs placebo and vs formoterol for the FEV₁ 50–<70% PN subpopulation and the all-patient population. Pooled data across four phase III/IV studies