Abstract
Introduction: The WISDOM study (NCT00975195) showed that in patients with severe to very severe COPD receiving tiotropium + salmeterol, risk of moderate or severe exacerbations was non-inferior in patients discontinuing inhaled corticosteroids (ICS) compared to those continuing ICS. However, patients in the ICS-withdrawal arm had a small reduction in trough FEV1 (43 mL; p<0.01). We analysed post hoc the relationship of the change in FEV1 in both treatment arms to moderate or severe exacerbations.
Methods: All patients were categorised into three groups according to the tertiles (33rd and 67th percentiles) of the change from baseline in trough FEV1 after 1 year of treatment; decrease (<-130 mL), medium change (≥-130 mL to <20 mL) or increase (≥20 mL). The change groups were analysed using descriptive statistics.
Results: The percentage of patients with moderate or severe on-treatment exacerbation was similar between the decrease and increase FEV1 change groups, and ∼10% higher in the medium change group (Table). These findings were similar in the ICS and ICS-withdrawal arms.
Conclusions: In the WISDOM study, no apparent relationship was observed between the magnitude of change in FEV1 and exacerbations over 1 year of treatment in patients with severe to very severe COPD receiving tiotropium + salmeterol, with or without ICS therapy.
Funding: Boehringer Ingelheim.
- Copyright ©ERS 2015