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Background  Asthma management may involve a step up in treatment when symptoms are not well controlled. We examined whether budesonide/formoterol maintenance and reliever therapy (MRT) is as effective as higher, fixed-dose budesonide plus as-needed terbutaline in patients requiring step-up from Step 2 treatment (low-dose inhaled corticosteroids), stratified by baseline reliever use.    Methods  A  post-hoc  analysis utilized data from three clinical trials of 6–12 months’ duration. Patients aged ≥12 years with symptomatic asthma uncontrolled despite Step 2 treatment were included. Severe exacerbation rate, lung function and reliever use were analysed, stratified by baseline reliever use (<1, 1–2 and >2 occasions/day).    Results  Overall, 1239 patients were included. Reductions in severe exacerbation rate with budesonide/formoterol MRT versus fixed-dose budesonide were similar across baseline reliever use levels, and were statistically significant in patients using 1–2 (42%,  p  = 0.01) and >2 (39%,  p  = 0.02) reliever occasions/day, but not <1 reliever occasion/day (35%,  p  = 0.11). Both treatments significantly increased mean FEV 1  from baseline; improvements were significantly greater for budesonide/formoterol MRT in all reliever use groups. Reductions in reliever use from baseline were significantly greater with budesonide/formoterol MRT versus fixed-dose budesonide in patients using 1–2 and >2 reliever occasions/day (−0.33 and −0.74 occasions/day, respectively).    Conclusions  Treatment benefit with budesonide/formoterol MRT versus higher, fixed-dose budesonide plus short-acting β 2 -agonist was found in Step 2 patients with relatively low reliever use, supporting the proposal that budesonide/formoterol MRT may be useful when asthma is uncontrolled with low-dose inhaled corticosteroid.    Electronic supplementary material  The online version of this article (doi:10.1186/s12890-017-0401-y) contains supplementary material, which is available to authorized users.

bmc pulmonary medicine

Efficacy of budesonide/formoterol maintenance and reliever therapy compared with higher-dose budesonide as step-up from low-dose inhaled corticosteroid treatment