Comparison of two twice-daily doses of budesonide/formoterol maintenance and reliever therapy An open, randomised pan-European clinical trial

The aim of this study was to compare two budesonide/formoterol maintenance doses within the budesonide/formoterol maintenance and reliever therapy concept, and to identify possible patient characteristics at baseline which would predict a better response to a higher than standard maintenance dose (NCT00463866). A total of 8424 patients with symptomatic asthma when using an inhaled corticosteroid (ICS) with or without a long-acting β2-agonist (LABA) were randomised to budesonide/formoterol 160/4.5 μg 1 (1x2) or 2 (2x2) inhalations bid. Patients used the same inhaler as needed for symptom relief. The primary outcome variable was time to first severe asthma exacerbation. In the total study population the time to first severe asthma exacerbation was prolonged by 18% with 2x2 vs 1x2 (hazard ratio 0.82; p=0.03). Lung function (peak expiratory flow) was the only statistically significant predictor for a better response to 2x2. The mean daily ICS doses were 737 and 463 μg in the 2x2 and 1x2 groups, respectively. In a real life setting budesonide/formoterol maintenance and reliever therapy at the 2x2 maintenance dose did prolong time to first severe exacerbation but at a higher medication load. Patients with low lung function benefited most from the higher maintenance dose.