Format

Send to

Choose Destination
Respir Med. 2014 Apr;108(4):593-9. doi: 10.1016/j.rmed.2014.01.002. Epub 2014 Jan 15.

Stepwise withdrawal of inhaled corticosteroids in COPD patients receiving dual bronchodilation: WISDOM study design and rationale.

Author information

1
Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, Member of the German Center for Lung Research, Grosshansdorf, Germany. Electronic address: magnussen@pulmoresearch.de.
2
Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, Member of the German Center for Lung Research, Grosshansdorf, Germany.
3
Department of Respiratory Diseases, University of Leuven, Leuven, Belgium.
4
Odense University Hospital, Odense, Denmark.
5
Institute of Ageing and Chronic Disease, University Hospital Aintree, Liverpool, UK.
6
Clinical Research Department, Boehringer Ingelheim (UK), Berkshire, UK.
7
Biometry and Data Management Department, Boehringer Ingelheim (UK), Berkshire, UK.
8
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany; Department of Sports Medicine, University of Tübingen, Tübingen, Germany.
9
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.

Abstract

Long-acting bronchodilators in combination with inhaled corticosteroids (ICS) are recommended to decrease the risk of recurrent exacerbations in patients with Global initiative for chronic Obstructive Lung Disease (GOLD) stage 3-4 chronic obstructive pulmonary disease (COPD). There is increasing concern about the clinical benefit and long-term safety of ICS use in COPD patients. The WISDOM (Withdrawal of Inhaled Steroids During Optimised bronchodilator Management) study (NCT00975195) aims to evaluate the need for ICS use via stepwise withdrawal of ICS in COPD patients (GOLD 3-4 with a history of at least one exacerbation during the 12-month period prior to screening) receiving dual bronchodilation. During the 6-week run-in period, 2456 patients receive tiotropium 18 μg once daily, salmeterol 50 μg twice daily and fluticasone 500 μg twice daily. In a randomized, double-blind, parallel-group, active-controlled fashion, one group of patients continues to receive tiotropium, salmeterol and fluticasone, while the second group initiates stepwise withdrawal of fluticasone. The primary end point is time to first moderate or severe exacerbation following randomized treatment over 52 weeks. Lung function, symptoms and safety are also assessed. A sub-study aims to identify sub-populations and markers of steroid need. This study will determine the benefit of continued ICS therapy in combination with dual long-acting bronchodilators in COPD.

KEYWORDS:

Chronic obstructive pulmonary disease; Dual bronchodilation; Exacerbation; Withdrawal of inhaled corticosteroid

PMID:
24477080
DOI:
10.1016/j.rmed.2014.01.002
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center