Efficacy and safety of budesonide/formoterol single inhaler therapy versus budesonide inhaler plus formoterol inhaler in asthma patients

Objective:To evaluate the efficacy and safety of budesonide/formoterol(B/F)single inhaler therapy versus budesonide inhaler plus formoterol inhaler(B+F)in asthma patients.Methods:A randomized,parallel control,multi-center clinical study recruited 320 patients with asthma,who were ran- domized to administer either B/F(n=158,group A)or B+F(n=162,group B).The primary endpoint was to measure the improvement of morning peak expiratory flow(mPEF),and secondary endpoints includ- ed the changes of evening PEF(ePEF),daytime and night-time asthma symptom scores,short-actingβ_2 agonist usages,awakening number due to shortness of breath at night and lung function during the follow- up pre-and post-therapy.All adverse events were also monitored.Results:Both therapeutic regimens sig- nificantly improved mPEF and ePEF and daytime and nighttime asthma symptom scores,and reduced hum- bers of short-actingβ_2 agonist usages and awakening number due to shortness of breath at night;the P val- ue was no statistical difference between two regimens.No differences in spirometrie measurements and ad- verse events were found between two regimens.Conclusion:Budesonide/formoterol single inhaler therapy was therapeutically equivalent to budesonide inhaler plus formoterol inhaler for patients with asthma.