The impact of stepwise withdrawal of inhaled corticosteroids on lung function in COPD patients receiving dual bronchodilation: WISDOM study

Abstract

Background: Although guidance recommends ICS for prevention of recurrent COPD exacerbations, there is still uncertainty about the benefits of ICS. Objective: To evaluate the effects of stepwise withdrawal of ICS in patients (pts) with GOLD 3–4 COPD and a history of exacerbation who are treated with LAMA+LABA. Methods: WISDOM ([NCT00975195][1]) was a 12-month, double-blind, parallel-group, active-controlled study in which 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). Primary end point (time to first moderate or severe on-treatment exacerbation) is reported here. Results: 2485 pts were treated (2049 male); mean age was 63.8 years and mean baseline FEV1 was 0.975 L (34.2% predicted). ![Figure][2] ICS withdrawal was non-inferior to continued ICS for time to first moderate or severe on-treatment COPD exacerbation (hazard ratio 1.058; upper limit of the 95% CI below the pre-specified non-inferiority margin of 1.2 [0.941, 1.189]). No significant safety signals were identified. Conclusions : In pts with GOLD 3–4 COPD receiving dual bronchodilation, exacerbation risk is non-inferior with ICS withdrawal compared to ICS therapy. Funding: Boehringer Ingelheim. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00975195&atom=%2Ferj%2F44%2FSuppl_58%2F1890.atom [2]: pending:yes