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 steroid therapy as a means of controlling symptoms in patients with severe asthma. However, it is well established that there are a number of undesirable adverse effects associated with this form of treatment. The aim of this study was to determine whether the addition of nebulised budesonide reduced oral steroid usage in oral steroid-dependent patients. Design: A 21- to 35-day run-in period allowed asthma stability to be assessed before patients were randomised in a double-blind manner to receive nebulised budesonide or placebo. At the end of the 15-week treatment period, all patients were given nebulised budesonide and followed for a further 4 weeks. Oral steroid reduction was also studied throughout the treatment period. Participants: 118 patients (aged 16 to 65 years) with severe oral steroid-dependent asthma (5 mg/day oral prednisolone and ≥800 µg/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 nebulised budesonide 2mg twice daily or nebulised placebo in addition to their existing oral steroid medication. Results: The addition of nebulised budesonide to existing oral steroid therapy 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 decrease in the severity of asthma symptoms such as cough (nebulised budesonide group: mean change -0.16; nebulised placebo group: +0.23; p < 0.05) breathlessness (-0.34 vs +0.06; p < 0.05) and sleep disturbance (-0.05 nights per week vs +0.93 nights per week; p < 0.01). Notably, these benefits were achieved without any deterioration in lung function and in conjunction with patients attempting to reduce their dosage of oral steroid. 68% of patients in the nebulised budesonide group were able to achieve a reduction in oral steroid 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 treatment can help to improve symptoms in patients with severe asthma. Moreover, this is achieved without an increase in steroid-related adverse effects. However, the percentage reduction in oral steroid usage between the nebulised budesonide group and the placebo group was not found to be significant (68 versus 53%). [ABSTRACT FROM AUTHOR]

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