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a McGill University Health Centre, McGill University,
Montreal, Canada, b St Sacrement Hospital,
Laval University, Quebec, Canada
Correspondence to: Dr J Bourbeau, Respiratory Epidemiology Unit, McGill University, 1110 Pine Avenue West, Montreal, Quebec, Canada H3A 1A3.
Received 9 September 1997; Returned to authors 7 November 1997; Revised version received 19 February 1998; Accepted for publication 27 February 1998
BACKGROUND
Inhaled corticosteroids are known to be
beneficial for patients with asthma, but their role in treating
patients with stable chronic obstructive pulmonary disease (COPD)
remains controversial. A study was undertaken to determine whether
inhaled corticosteroids are of functional benefit in patients who did
not show improvement with a trial of oral corticosteroids.
METHODSIn phase I patients with stable COPD were
given a two week course of oral placebo followed by two weeks of
prednisone 40 mg per day in a single blind manner to distinguish
between responders and non-responders to oral corticosteroids. In phase
II a double blind, randomised, parallel group trial of inhaled
budesonide 1600 µg per day versus placebo was carried out in 79 non-responders to oral corticosteroids. The primary outcome measure was
forced expiratory volume in one second (FEV1), and
secondary outcome measures were exercise capacity, dyspnoea with
exertion, quality of life, peak expiration flow rate, and respiratory symptoms.
RESULTSRandomisation allocated 39 subjects to
inhaled corticosteroids and 40 to placebo. There was no difference in
the change in FEV1 from baseline between the treatment and
placebo groups; mean difference -12 ml (95% CI -88 to 63) at three
months and -4 ml (95% CI -95 to 87) at six months. The proportion
of patients with a 15% or greater improvement was no higher among
those receiving inhaled corticosteroids than in the placebo group at
any of the follow up visits. Changes in secondary outcomes were also no different.
CONCLUSIONSInhaledcorticosteroids,
even at high doses, were of no physiological or functional benefit in
these patients with advanced COPD.
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