Lung-Function Profile Before and After the First Moderate to Severe Exacerbation During the WISDOM Study

Rationale The WISDOM study (NCT00975195) showed no increased risk of exacerbation when inhaled corticosteroid (ICS) was withdrawn stepwise in patients with severe COPD on LAMA+LABA maintenance therapy versus continued LAMA+LABA+ICS. 1 Daily home spirometry measured the time course of lung-function changes throughout the study. The aim of this post hoc analysis was to address the lung-function profile leading up to, during and following the first moderate-to-severe exacerbation. Methods WISDOM was a multinational, randomised, double-blind study. 1 Patients with severe to very severe COPD entered a 6-week run-in with LAMA+LABA+ICS (tiotropium 18 µg once daily; salmeterol 50 µg twice daily; fluticasone propionate 500 µg twice daily), and were randomised to continue LAMA+LABA+ICS or salmeterol/tiotropium for 52 weeks while discontinuing ICS in a stepwise manner over 12 weeks. On-treatment daily forced expiratory volume in 1 second (FEV 1 ) change from baseline was calculated before and after the first moderate-to-severe exacerbation. In this post hoc analysis, we included patients who experienced a moderate-to-severe exacerbation after the ICS-withdrawal visit, did not have an exacerbation in the 8 weeks before or after the exacerbation, and had daily home-measured FEV 1 data available for every week analysed. Results Of 2488 patients, 262 experienced a moderate-to-severe exacerbation after the ICS-withdrawal visit and had lung-function data for every week. For all patients combined (ICS and ICS withdrawal), change in FEV 1 remained relatively stable 56–14 days before the first moderate-to-severe exacerbation (mean FEV 1 change from baseline values: −0.04 to −0.07 L) (Figure). There was a decline in lung function starting 2–3 weeks before exacerbation (FEV 1 change value of −0.12 L from baseline), followed by a moderate improvement over ∼14 days. Post-exacerbation lung function did not reach pre-exacerbation levels. Conclusions Lung function was relatively stable in both treatment groups. Home spirometry measurements showed a marked decline in FEV 1 prior to moderate-to-severe exacerbation with improvements seen post-exacerbation, although not to pre-exacerbation levels. These findings support the usefulness of home spirometry to predict exacerbations and to indicate subsequent worsening of lung function resulting from a previous COPD exacerbation. Funding Boehringer Ingelheim. Please refer to page A273 for declarations of interest in relation to abstract P297. Reference Magnussen H, et al . N Engl J Med 2014; 371 :1285–1294.