Effect of discontinuation of inhaled corticosteroids in patients with chronic obstructive pulmonary disease: the COPE study

Am J Respir Crit Care Med. 2002 Nov 15;166(10):1358-63. doi: 10.1164/rccm.200206-512OC. Epub 2002 Sep 5.

Abstract

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 in patients with chronic obstructive pulmonary disease. After 4 months of treatment with FP (1,000 microg/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 with 69 (57%) in the placebo group. The hazard ratio of a first exacerbation in the placebo group compared with the FP group was 1.5 (95% confidence interval [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 with 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 patients with chronic obstructive pulmonary disease is associated with a more rapid onset and higher recurrence-risk of exacerbations and a significant deterioration in aspects of Health-Related Quality of Life.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Adrenal Cortex Hormones / administration & dosage*
  • Adrenal Cortex Hormones / adverse effects
  • Adult
  • Aged
  • Androstadienes / administration & dosage
  • Androstadienes / adverse effects
  • Double-Blind Method
  • Exercise Tolerance / drug effects
  • Exercise Tolerance / physiology
  • Female
  • Fluticasone
  • Follow-Up Studies
  • Forced Expiratory Volume / drug effects
  • Forced Expiratory Volume / physiology
  • Humans
  • Lung / blood supply
  • Lung / drug effects
  • Lung / physiology
  • Male
  • Middle Aged
  • Pulmonary Disease, Chronic Obstructive / chemically induced
  • Pulmonary Disease, Chronic Obstructive / drug therapy*
  • Quality of Life
  • Recurrence
  • Severity of Illness Index
  • Smoking
  • Substance Withdrawal Syndrome / diet therapy
  • Substance Withdrawal Syndrome / etiology
  • Treatment Outcome

Substances

  • Adrenal Cortex Hormones
  • Androstadienes
  • Fluticasone