Withdrawal of Inhaled Corticosteroids in Patients With COPD in Primary Care
Status:
Completed
Trial end date:
2004-03-01
Target enrollment:
Participant gender:
Summary
Guidelines recommend inhaled corticosteroids (ICS) for patients with moderate to 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.This randomised double-blind placebo-controlled
trial will evaluate the effect of withdrawal of inhaled corticosteroids in patients with COPD
recruited from general practice. Participants will have a clinical and spirometric diagnosis
of COPD and will have been prescribed inhaled steroids for the 6 months before entry to the
trial. They will be randomised to taking a fixed dose steroid inhaler (Flixotide Accuhaler)
or an identical placebo inhaler. Patients will be monitored using diary cards for a year with
3 monthly follow-up visits at their general practice. The primary outcome measures will be
exacerbation frequency and severity. Other outcomes are time to first exacerbation, costs,
health status, lung function and unscheduled care. We tested the hypothesis that withdrawal
of ICS in this population would lead to an increased number of exacerbations, earlier onset
of exacerbation, and a worsening of symptoms.