The impact of stepwise withdrawal of inhaled corticosteroids on lung function in COPD patients receiving dual bronchodilation: WISDOM study
Background: WISDOM (NCT00975195) demonstrated non-inferiority in exacerbation risk with ICS withdrawal versus ICS (ERS 2014). Here we report the change in lung function.
Objective: To evaluate the effects of stepwise withdrawal of ICS in patients (pts) with GOLD 3 – 4 COPD and a history of exacerbation treated with LAMA+LABA.
Methods: WISDOM was a 12-month, double-blind, parallel-group, active-controlled study where all pts received triple therapy (tiotropium 18 µg QD, salmeterol 50 µg BID and fluticasone 500 µg BID) for a 6-week run-in period. Pts were randomised 1:1 to continue triple therapy or stepwise withdrawal of ICS over 12 weeks (dose reduction every 6 weeks). Secondary end points included trough FEV1.
Results: 2485 pts were treated (2049 male); mean age was 63.8 years and mean baseline FEV1 was 0.975 L (34.2% predicted). At Week 18, the adjusted mean decrease from baseline (Week 0) in trough FEV1 was 38 mL greater on complete ICS withdrawal than on ICS (p < 0.0001), with similar results at Week 52.
Conclusions: While exacerbation risk is comparable irrespective of concomitant ICS therapy in pts with GOLD 3 – 4 COPD receiving dual bronchodilation, there was a small but statistically significantly greater decrease in lung function with complete ICS withdrawal.
Funding: Boehringer Ingelheim.
Presented at ERS congress 2014