EFFECT OF LONG-TERM TREATMENT WITH SALMETEROL ON ASTHMA CONTROL - A DOUBLE-BLIND, RANDOMIZED CROSSOVER STUDY

Objectives: To determine the effect of adding salmeterol 50 mu g twice daily for six months to current treatment in subjects with asthma who control their inhaled corticosteroid dose according to a management p lan. Design: A double blind, randomised crossover study. Setting: Nott ingham. Subjects: 101 subjects with mild or moderate asthma taking at least 200 mu g twice daily of beclomethasone dipropionate or budesonid e. Interventions: Salmeterol 50 mu g twice daily and placebo for six m onths each, with a one month washout. Subjects adjusted inhaled steroi d dose according to guidelines. Main outcome measure: Reduction in inh aled steroid use, exacerbations of asthma, and use of oral steroids. R esults: Data were available for 87 subjects. When compared with placeb o salmeterol treatment was associated with a 17% reduction in inhaled steroid use (95% confidence interval 12% to 22%) with no significant d ifference in the number of subjects who had an exacerbation (placebo 2 5%, salmeterol 16%) or use of oral steroids, For secondary end points salmeterol treatment was associated with higher morning and evening pe ak expiratory flow and forced expiratory volume in one second; a reduc tion in symptoms, bronchodilator use, and airway responsiveness to met hacholine; and no effect on serum potassium concentration, 24 hour hea rt rate, or the final forced expiratory volume in one second achieved during a salbutamol dose-response study. Conclusions: Ln subjects who adjusted their inhaled steroid treatment according to guidelines the a ddition of salmeterol 50 mu g twice daily was associated with a reduct ion in inhaled steroid use and improved lung function and symptom cont rol.