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Published ahead of print on September 5, 2002, doi:10.1164/rccm.200206-512OC

Am. J. Respir. Crit. Care Med., Volume 166, Number 10, November 2002, 1358-1363

A more recent version of this article appeared on November 15, 2002
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Submitted on June 5, 2002
Accepted on August 31, 2002

Effect of discontinuation of inhaled steroids in patients with COPD: the COPE study

Paul van der Valk1*, Evelyn Monninkhof1, Job van der Palen1, Gerhard Zielhuis2, and Cees van Herwaarden3

1 Pulmonary Medicine, Medisch Spectrum Twente, Enschede, The Netherlands, 2 Epidemiology and Biostatistics, University Medical Center, Nijmegen, The Netherlands, 3 Pulmonary Medicine, University Medical Center, Nijmegen, The Netherlands

* To whom correspondence should be addressed. E-mail: valkpapa{at}knmg.nl.

The aim of this double-blind single center study (the COPE study) was to investigate the effect of discontinuation of the inhaled corticosteroid fluticasone propionate (FP) on exacerbations and Health-Related Quality of Life (HRQL) in patients with Chronic Obstructive Pulmonary Disease (COPD). After 4 months of treatment with FP (1000 [mu]g /day), 244 patients were randomized to either continue FP or to receive placebo for 6 months: 123 patients continued FP (FP-group) and 121 received placebo (placebo group). In the FP-group, 58 (47%) patients developed at least one exacerbation compared to 69 (57%) in the placebo-group. The hazard ratio of a first exacerbation in the placebo-group compared to the FP-group was 1.5 (95% CI 1.1-2.1). In the placebo-group 26 patients (21.5%) experienced rapid recurrent exacerbations and were subsequently unblinded and prescribed FP compared to 6 patients (4.9 %) in the FP-group (Relative Risk = 4.4; 95% CI 1.9-10.3). Over a 6-month period, a significant difference in favor of the FP-group was observed in the total score (+ 2.48 95% CI 0.37-4.58), activity domain (+4.64 95% CI 1.60-7.68) and symptom domain (+4.58 95% CI 1.05-8.10) of the St George's Respiratory Questionnaire. This study indicates that discontinuation of FP in COPD patients is associated with a more rapid onset and higher recurrence-risk of exacerbations and a significant deterioration in aspects of HRQL.
Key words: COPD, inhaled corticosteroids, exacerbations, Health-Related Quality of Life




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