Challenging current asthma treatment guidelines - Improved control of asthma symptoms with nebulised budesonide in patients with severe asthma receiving continuous oral steroids

Objective: British Thoracic Society guidelines advocate the use of oral ste roid therapy as a means of controlling symptoms in patients with severe ast hma. However, it is well established that there are a number of undesirable adverse effects associated with this form of treatment. The aim of this st udy was to determine whether the addition of nebulised budesonide reduced o ral steroid usage in oral steroid-dependent patients. Design: A 21- to 35-day run-in period allowed asthma stability to be assess ed before patients were randomised in a double-blind manner to receive nebu lised budesonide or placebo. At the end of the 15-week treatment period, al l patients were given nebulised budesonide and followed for a further 4 wee ks. Oral steroid reduction was also studied throughout the treatment period . Participants: 118 patients (aged 16 to 65 years) with severe oral steroid-d ependent asthma (5 mg/day oral prednisolone and greater than or equal to 80 0 mu g/day inhaled steroid) were enrolled into the study. Of these, 76 were randomised to receive nebulised budesonide or placebo. Interventions: Eligible patients were randomised to receive either nebulise d budesonide 2mg twice daily or nebulised placebo in addition to their exis ting oral steroid medication. Results: The addition of nebulised budesonide to existing oral steroid ther apy provided a significant reduction in the number of asthma exacerbations experienced over the 15-week treatment period compared with placebo (1.1 vs 0.35; p < 0.05). Moreover, this seemed to be coupled with a marked decreas e in the severity of asthma symptoms such as cough (nebulised budesonide gr oup: mean change -0.16; nebulised placebo group: +0.23; p < 0.05) breathles sness (-0.34 vs +0.06; p < 0.05) and sleep disturbance (-0.05 nights per we ek vs +0.93 nights per week; p < 0.01). Notably, these benefits were achiev ed without any deterioration in lung function and in conjunction with patie nts attempting to reduce their dosage of oral steroid. 68% of patients in t he nebulised budesonide group were able to achieve a reduction in oral ster oid dosage, compared with 53% in the placebo group. although this was not a significant difference. Conclusions: The addition of nebulised budesonide to regular oral steroid t reatment can help to improve symptoms in patients with severe asthma. Moreo ver, this is achieved without an increase in steroid-related adverse effect s. However, the percentage reduction in oral steroid usage between the nebu lised budesonide group and the placebo group was not found to be significan t (68 versus 53%).