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Randomised controlled trial of inhaled corticosteroids inpatients with chronic obstructive pulmonary disease |
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| Authors: | J. Bourbeau M. Rouleau S. Boucher |
| Affiliation: | McGill University Health Centre, McGill University, Montreal, Canada. |
| Abstract: | BACKGROUND—Inhaled corticosteroids are known to bebeneficial for patients with asthma, but their role in treatingpatients with stable chronic obstructive pulmonary disease (COPD)remains controversial. A study was undertaken to determine whetherinhaled corticosteroids are of functional benefit in patients who didnot show improvement with a trial of oral corticosteroids. METHODS—In phase I patients with stable COPD weregiven a two week course of oral placebo followed by two weeks ofprednisone 40 mg per day in a single blind manner to distinguishbetween responders and non-responders to oral corticosteroids. In phaseII a double blind, randomised, parallel group trial of inhaledbudesonide 1600 µg per day versus placebo was carried out in 79 non-responders to oral corticosteroids. The primary outcome measure wasforced expiratory volume in one second (FEV1), andsecondary outcome measures were exercise capacity, dyspnoea withexertion, quality of life, peak expiration flow rate, and respiratory symptoms. RESULTS—Randomisation allocated 39 subjects toinhaled corticosteroids and 40 to placebo. There was no difference inthe change in FEV1 from baseline between the treatment andplacebo groups; mean difference -12 ml (95% CI -88 to 63) at threemonths and -4 ml (95% CI -95 to 87) at six months. The proportionof patients with a 15% or greater improvement was no higher amongthose receiving inhaled corticosteroids than in the placebo group atany 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 inthese patients with advanced COPD. |
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