Randomised trial of an inhaled beta(2) agonist, inhaled corticosteroid andtheir combination in the treatment of asthma

Background-Although many asthmatic patients are treated with a combination of beta(2), agonist and corticosteroid inhalers, the clinical effects of co mbining the drugs are unknown. Studies on the early asthmatic response to a llergen suggest that beta(2) agonists may reduce the benefit of inhaled cor ticosteroids. A study of the effects of combining the drugs on asthma contr ol was undertaken. Methods-Sixty one subjects with mild to moderate asthma were randomised to a double blind crossover comparison of inhaled budesonide (200-400 mu g twi ce daily), terbutaline (500-1000 pg four times daily), combined treatment, and placebo. Each treatment was given for six weeks following a four week w ashout period. Ipratropium was used for symptom relief. Treatments were ran ked from worst (1) to best (4) based on need for oral steroid, mean morning peak flow, nocturnal awakening, ipratropium use, and asthma symptoms. Lung function and bronchial hyperresponsiveness were measured before and after each treatment. Results-Evaluable data for all four treatments were obtained from 47 subjec ts. The mean rank of each treatment was: placebo 2.05; terbutaline = 2.13; budesonide 2.48; combined treatment = 3.34. Combined treatment was ranked s ignificantly better than any other treatment (p<0.01). Mean (95% CI) mornin g and evening peak flows were 14 (5 to 23) and 24 (15 to 34) 1/min higher, respectively, during combined treatment than during budesonide, and 27 (17 to 37) and 15 (7 to 23) 1/min higher than during terbutaline. Asthma sympto ms tended to be least frequent during combined treatment but were not signi ficantly different from budesonide alone. There was no significant differen ce between combined treatment and budesonide alone for lung function and br onchial hyperresponsiveness. Conclusions-In this group of mild to moderate asthmatic subjects the combin ation of beta(2), agonist and corticosteroid gave better asthma control tha n either treatment alone. There was no evidence that regular beta(2) agonis t treatment impaired the beneficial effect of inhaled corticosteroid.