Abstract
BackgroundGuidelines recommend inhaled corticosteroids (ICS) for patients with severe chronic obstructive pulmonary disease (COPD). Most COPD patients are managed in primary care and receive ICS long-term and irrespective of severity. The effect of withdrawing ICS from COPD patients in primary care is unknown.MethodsIn a pragmatic randomised, double-blind, placebo-controlled trial in 31 practices, 260 COPD patients stopped their usual ICS (median duration of use 8 years) and were allocated to 500 mcg fluticasone propionate twice daily (n = 128), or placebo (n = 132). Follow-up assessments took place at three monthly intervals for a year at the patients' practice. Our primary outcome was COPD exacerbation frequency. Secondary outcomes were time to first COPD exacerbation, reported symptoms, peak expiratory flow rate and reliever inhaler use, and lung function and health related quality of life.ResultsIn patients randomised to placebo, COPD exacerbation risk over one year was RR: 1.11 (CI: 0.91–1.36). Patients taking placebo were more likely to return to their usual ICS following exacerbation, placebo: 61/128 (48%); fluticasone: 34/132 (26%), OR: 2.35 (CI: 1.38–4.05). Exacerbation risk whilst taking randomised treatment was significantly raised in the placebo group 1.48 (CI: 1.17–1.86). Patients taking placebo exacerbated earlier (median time to first exacerbation: placebo (days): 44 (CI: 29–59); fluticasone: 63 (CI: 53–74), log rank 3.81, P = 0.05) and reported increased wheeze. In a post-hoc analysis, patients with mild COPD taking placebo had increased exacerbation risk RR: 1.94 (CI: 1.20–3.14).ConclusionWithdrawal of long-term ICS in COPD patients in primary care increases risk of exacerbation shortens time to exacerbation and causes symptom deterioration. Patients with mild COPD may be at increased risk of exacerbation after withdrawal.Trial RegistrationClinicalTrials.gov NCT00440687
Highlights
Exacerbations in patients with chronic obstructive pulmonary disease (COPD) worsen health status [1,2] and are an important cause of consultations in primary care [3] and hospital admission [4]
Eighty-five percent of patients with COPD in the UK and the Netherlands are managed exclusively in primary care, a figure increasing with the rising awareness and identification of mild COPD in primary care [15,16]
Double-blind, placebo-controlled study, we examined the effects of withdrawing inhaled corticosteroids (ICS) in people with COPD recruited in primary care
Summary
Exacerbations in patients with chronic obstructive pulmonary disease (COPD) worsen health status [1,2] and are an important cause of consultations in primary care [3] and hospital admission [4]. Patients with COPD in primary care have often been prescribed ICS long-term, prior to the introduction of recent guidelines, and irrespective of their exacerbation frequency or lung function. It is not known whether withdrawing ICS in this population would lead to more exacerbations, and how withdrawal might affect daily symptoms and symptom profile at exacerbation. Guidelines recommend inhaled corticosteroids (ICS) for patients with severe chronic obstructive pulmonary disease (COPD). Most COPD patients are managed in primary care and receive ICS long-term and irrespective of severity. The effect of withdrawing ICS from COPD patients in primary care is unknown
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