Withdrawal of inhaled corticosteroids in people with COPD in primary care: a randomised controlled trial

Aklak B Choudhury¹ , Carolyn M Dawson¹ , Hazel E Kilvington¹ , Sandra Eldridge¹ , Wai-Yee James¹ , Jadwiga A Wedzicha² , Gene S Feder¹ and Chris J Griffiths¹^,3

¹Centre for Health Sciences, Queen Mary's School of Medicine and Dentistry, Barts and The London, 2 Newark Street, London, E1 2AT, UK

²Academic Unit of Respiratory Medicine, Royal Free and University College Medical School, Hampstead Campus, Rowland Hill Street, Hampstead, London, NW3 2PF UK

³MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, 5th Floor Thomas Guy House, Guy's Hospital, London, SE1 9RT, UK

author email corresponding author email

Respiratory Research 2007, 8:93doi:10.1186/1465-9921-8-93


Published:	27 December 2007

Abstract

Background

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.

Methods

In 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.

Results

In 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).

Conclusion

Withdrawal 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 Registration

ClinicalTrials.gov NCT00440687