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Previous Volume 340:1948-1953 June 24, 1999 Number 25 Next

	Full Text PDF Editorial by Boushey, H. A. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background and Methods Although patients with chronic obstructive pulmonary disease (COPD) should stop smoking, some do not. In a double-blind, placebo-controlled study, we evaluated the effect of the inhaled glucocorticoid budesonide in subjects with mild COPD who continued smoking. After a six-month run-in period, we randomly assigned 1277 subjects (mean age, 52 years; mean forced expiratory volume in one second [FEV₁], 77 percent of the predicted value; 73 percent men) to twice-daily treatment with 400 µg of budesonide or placebo, inhaled from a dry-powder inhaler, for three years.

Results Of the 1277 subjects, 912 (71 percent) completed the study. Among these subjects, the median decline in the FEV₁ after the use of a bronchodilator over the three-year period was 140 ml in the budesonide group and 180 ml in the placebo group (P=0.05), or 4.3 percent and 5.3 percent of the predicted value, respectively. During the first six months of the study, the FEV₁ improved at the rate of 17 ml per year in the budesonide group, as compared with a decline of 81 ml per year in the placebo group (P<0.001). From nine months to the end of treatment, the FEV₁ declined at similar rates in the two groups (P=0.39). Ten percent of the subjects in the budesonide group and 4 percent of those in the placebo group had skin bruising (P<0.001). Newly diagnosed hypertension, bone fractures, postcapsular cataracts, myopathy, and diabetes occurred in less than 5 percent of the subjects, and the diagnoses were equally distributed between the groups.

Conclusions In persons with mild COPD who continue smoking, the use of inhaled budesonide is associated with a small one-time improvement in lung function but does not appreciably affect the long-term progressive decline.

Source Information

From the Department of Respiratory Diseases, University Hospital, Ghent, Belgium (R.A.P.); the Department of Respiratory Medicine, University Hospital, Lund, Sweden (C.-G.L.); the Department of Medicine, University Central Hospital, Helsinki, Finland (L.A.L.); the Department of Epidemiology and Statistics, University of Groningen, Groningen, the Netherlands (J.P.S.); the Division of Respiratory Disease, University Hospital, Groningen, the Netherlands (D.S.P.); the Respiratory Division, Imperial College School of Medicine, Hammersmith Hospital, London (N.B.P.); and Clinical Research and Development, Astra Draco, Lund, Sweden (S.V.O.).

Address reprint requests to Dr. Pauwels at the Department of Respiratory Diseases, University Hospital, De Pintelaan 185, B9000 Ghent, Belgium, or at romain.pauwels{at}rug.ac.be.

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