RANDOMIZED CONTROLLED TRIAL OF INHALED CORTICOSTEROIDS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY-DISEASE

Background-Inhaled corticosteroids are known to be beneficial for pati ents with asthma, but their role in treating patients with stable chro nic obstructive pulmonary disease (COPD) remains controversial. A stud y was undertaken to determine whether inhaled corticosteroids are of f unctional benefit in patients who did not show improvement with a tria l of oral corticosteroids. Methods-In phase I patients with stable COP D were given a two week course of oral placebo followed by two weeks o f prednisone 40 mg per day in a single blind manner to distinguish bet ween responders and non-responders to oral corticosteroids. In phase I I a double blind, randomised, parallel group trial of inhaled budesoni de 1600 mu g per day versus placebo was carried out in 79 nonresponder s to oral corticosteroids. The primary outcome measure was forced expi ratory volume in one second (FEV,), and secondary outcome measures wer e exercise capacity, dyspnoea with exertion, quality of Life, peak exp iration flow rate, and respiratory symptoms. Results-Randomisation all ocated 39 subjects to inhaled corticosteroids and 40 to placebo. There was no difference in the change in FEV, from baseline between the tre atment and placebo groups; mean difference -12 ml (95% CI -88 to 63) a t three months and -4 ml (95% CI -95 to 87) at six months. The proport ion of patients with a 15% or greater improvement was no higher among those receiving inhaled corticosteroids than in the placebo group at a ny of the follow up visits. Changes in secondary outcomes were also no different. Conclusions-Inhaled corticosteroids, even at high doses, w ere of no physiological or functional benefit in these patients with a dvanced COPD.