Improved asthma control with budesonide/formoterol in a single inhaler, compared with budesonide alone

Budesonide/formoterol in a single inhaler was compared with budesonide alon e, and with concurrent administration of budesonide and formoterol from sep arate inhalers, in patients with asthma, not controlled with inhaled glucoc orticosteroids alone. In this 12-week, double-blind, randomized, double-dum my study, 362 adult asthmatics (forced expiratory volume in one second 73.8 % of predicted, inhaled glucocorticosteroid dose 960 mug(.)day(-1)) receive d single inhaler budesonide/formoterol (Symbicort (R) Turbuhaler (R)) 160/4 .5 mug, two inhalations b.i.d., or corresponding treatment with budesonide, or budesonide plus formoterol via separate inhalers. There was a greater i ncrease in morning peak expiratory flow (PEF) with single-inhaler (35.7 L(. )min(-1)) and separate-inhaler (32.0 L(.)min(-1)) budesonide and formoterol , compared with budesonide alone (0.2 L(.)min(-1); p <0.001, both compariso ns); the effect was apparent after 1 day (p <0.001 versus budesonide, both comparisons). Similarly, evening PEF, use of rescue medication, total asthm a symptom scores and percentage of symptom-free days improved more with bot h single inhaler and separate inhaler therapy than with budesonide alone, a s did asthma control days (similar to 15% more, p <0.001 versus budesonide, both comparisons, with a marked increase in the first week). All treatment s were well tolerated and the adverse event profile was similar in all thre e treatment groups. It is concluded that single inhaler therapy with budeso nide and formoterol is a clinically effective and well-tolerated treatment for patients with asthma that is not fully controlled by inhaled glucocorti costeroids alone.