Low-dose budesonide with the addition of an increased dose during exacerbations is effective in long-term asthma control

Objectives: This study was designed to compare the effects of a 6-month tre atment with budesonide 100 mu g bid (low dose) and 100 mu g bid (standard r eference dose) in controlling symptoms and lung function in a group of asth matics with moderate asthma (baseline FEV1 greater than or equal to 50% and less than or equal to 90% of predicted values) previously treated with inh aled beclomethasone dipropionate (500 to 1,000 mu g/d). Moreover, we invest igated whether or not asthma exacerbations could be treated by a short-term increase in the daily dose of budesonide. Methods: After a 2-week run-in period and 1-month treatment with a high dos e of budesonide (800 mu g bid), 213 patients with moderate asthma were assi gned to randomized treatments, Daily treatment included budesonide (bid) pl us an additional treatment in case of exacerbation (qid for 7 days). Treatm ents were as follows: budesonide 400 mu g plus placebo (group 1); budesonid e 100 mu g plus budesonide 200 mu g (group 2); and budesonide 100 mu g plus placebo (group 3). Symptoms and a peak expiratory flow (PEF) diary were re corded and lung function was measured each month. An exacerbation was defin ed as a decrease in PEF > 30% below baseline values on 2 consecutive days. Results: We found that that 1-month treatment with a high budesonide dose r emarkably reduced all asthma symptoms. Moreover, symptoms were under contro l in all treatment groups throughout the study period. Similarly, lung func tion improved and remained stable, and no relevant differences between grou ps were observed. In each treatment group, the majority of patients had no exacerbations. In patients treated with the standard budesonide dose (group 1), the number of exacerbations and days with exacerbations were significa ntly lower than in group 3 (intention-to-treat analysis), Additionally, pat ients treated with low budesonide dose plus budesonide (group 2) experience d a significantly lower number of exacerbations and days with exacerbations compared to group 3 (per-protocol analysis). Conclusions: This study demonstrates that when patients with moderate asthm a had reached a stable clinical condition with a high dose of budesonide, a low dose of budesonide (200 mu g/d) is as effective as the standard dose ( 800 mu g/d) in the control of symptoms and lung function over a period of s everal months. Furthermore, results showed that the addition of inhaled bud esonide (800 mu g/d) at onset of an asthmatic exacerbation has a beneficial clinical effect.