Randomised controlled trial of inhaled corticosteroids in patients with chronic obstructive pulmonary disease

Abstract

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.

METHODS In 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.

RESULTS Randomisation 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.

CONCLUSIONS Inhaledcorticosteroids, even at high doses, were of no physiological or functional benefit in these patients with advanced COPD.