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1 From the Department of Pulmonology, University of Groningen, the Netherlands
2 From the Department of Epidemiology, University of Groningen, the Netherlands
Study objective: To determine the effectiveness of treatment with corticosteroids in patients with COPD.
Methods: In this study, we investigated the effect of a 2-year treatment with corticosteroids on clinical symptoms and the decline of lung function in 58 nonallergic patients with COPD. Subjects were treated in a double-blind, randomized, placebo-controlled, parallel way with inhaled budesonide (bud), 1,600 µg/d; inhaled budesonide, 1,600 µg/d, plus oral prednisolone, 5 mg/d (bud+pred); or placebo (plac). Clinical assessment (history, physical examination, and spirometry) was carried out every 2 months. The rate of decline in FEV1 was assessed by calculating individual regression Coefficients from linear regression of FEV1 on time for each subject.
Results: Eleven patients dropped out. The number of withdrawals due to pulmonary problems was significantly higher in the plac group (n=5 out of 18) than in the actively treated groups (n=2 out of 40). Treatment with corticosteroids significantly reduced pulmonary symptoms. Median decline of FEV1 was 60 mL/yr in the plac group, 40 mL/yr in the bud+pred group, and 30 mL/yr in the bud group. Variation was large and differences were not statistically significant. No treatment effect was found on frequency or duration of exacerbations, possibly because of the high number of withdrawals due to pulmonary deterioration in the plac group. Treatment with a combination of inhaled plus oral corticosteroids was not more effective than inhaled corticosteroids alone. Morning plasma cortisol levels remained within the normal range in all three groups.
Conclusions: Our study shows beneficial effects of long-term daily treatment with inhaled corticosteroids in patients with COPD with regard to symptoms and drop out due to pulmonary problems. Lung function decline tends to decrease during treatment with inhaled corticosteroids. The observed effects are limited but warrant further studies on the effectiveness of corticosteroids in larger numbers of patients with COPD.
Key Words: corticosteroids • budesonide • prednisolone • chronic obstructive pulmonary disease • FEV1 • exacerbations • symptoms
Submitted on May 25, 1995
Accepted on November 29, 2007
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