Long-term effect of inhaled budesonide in mild and moderate chronic obstructive pulmonary disease: a randomised controlled trial

Background. Little is known about the long-term efficacy of inhaled cortico steroids in chronic obstructive pulmonary disease (COPD). We investigated t he efficacy of inhaled budesonide on decline in lung function and respirato ry symptoms in a 3-year placebo-controlled study of patients with COPD. Methods. We used a parallel-group, randomised, double-blind, placebo-contro lled design in a single-centre study, nested in a continuing epidemiologica l survey (the Copenhagen City Heart Study). Inclusion criteria were as foll ows: no asthma; a ratio of forced expiratory volume in 1 s (FEV1) and vital capacity of 0.7 or less; FEV, which showed no response (<15% change) to 1 mg inhaled terbutaline or prednisolone 37.5 mg orally once daily for 10 day s. 290 patients were randomly assigned budesonide, 800 mu g plus 400 mu g d aily for 6 months followed by 400 mu g twice daily for 30 months, or placeb o for 36 months. The mean age of the participants was 59 years and the mean FEV1 2.37 L or 86% of predicted. The main outcome measure was rate of FEV, decline. Analyses were by intention to treat. Findings. The crude rates of FEV, decline were slightly smaller than expect ed (placebo group 41.8 mt per year, budesonide group 45.1 mL per year). The estimated rates of decline from the regression model did not differ signif icantly (49.1 mL vs 46.0 mL per year; difference 3.1 mL per year [95% Cl -1 2.8 to 19.0]; p = 0.7). Before the study, the minimum relevant difference w as defined as 20 mL per year; this difference was outside the 95% CI. No ef fect of inhaled budesonide was seen on respiratory symptoms. 316 exacerbati ons occurred during the study period, 155 in the budesonide group and 161 i n the placebo group. Treatment was well tolerated. Interpretation. Inhaled budesonide was of no clinical benefit in COPD patie nts recruited from the general population by screening. We question the rol e of long-term inhaled corticosteroids in the treatment of mild to moderate COPD.