Pneumologie 2015; 69 - P75
DOI: 10.1055/s-0035-1544632

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

H Magnussen 1, P Chanez 2, R Dahl 3, M Decramer 4, B Disse 5, H Finnigan 6, AM Kirsten 1, R Rodriguez-Roisin 7, K Tetzlaff 8, L Towse 9, H Watz 1, E Wouters 10, P Calverley 11
  • 1Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North
  • 2Service de Pneumologie, Hôpital Nord, Marseille
  • 3Allergy Centre, Odense University Hospital
  • 4Department of Respiratory Diseases, University of Leuven
  • 5Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG
  • 6Biometry and Data Management Department, Boehringer Ingelheim (UK)
  • 7Servei de Pneumologia (ICT), Hospital Clínic-IDIBAPS-CIBERES, Barcelona
  • 8Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG – Ingelheim; Department of Sports Medicine, University of Tübingen
  • 9Clinical Research Department, Boehringer Ingelheim (UK)
  • 10Department of Respiratory Medicine, Maastricht University Medical Centre (MUMC+)
  • 11Institute of Ageing and Chronic Disease, University Hospital Aintree, Liverpool

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) 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).

Fig. 1.: Kaplan-Meier estimates of moderate or severe on-treatment COPD exacerbation

Time to events (days)

No. at risk

ICS

1243

1059

927

827

763

694

646

615

581

14

ICS withdrawal

1242

1090

965

825

740

688

646

607

570

19

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.

Presented at ERS congress 2014