Pneumologie 2015; 69 - P67
DOI: 10.1055/s-0035-1544631

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

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

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.

Fig. 1

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