25610500
OBJECTIVE	Fluticasone and formoterol are effective in the treatment of asthma .
OBJECTIVE	When a corticosteroid alone fails to control asthma , combination therapy is the treatment of choice .
OBJECTIVE	The objective of this study was to compare the efficacy and safety of formulations containing budesonide/formoterol ( BUD/FOR ) , fluticasone alone ( FLU ) , and the single-capsule combination of fluticasone/formoterol ( FLU/FOR ) on lung function in patients with mild-to-moderate persistent asthma .
METHODS	This was a randomized , multicenter , open phase III trial conducted in Brazil .
METHODS	The primary efficacy analysis was the assessment of non-inferiority between FLU/FOR and BUD/FOR combinations regarding FEV1 ( in L ) at the final visit .
METHODS	The secondary analyses were PEF , level of asthma control , serum cortisol levels , frequency of adverse events , adherence to treatment , and appropriate inhaler use .
RESULTS	We randomized 243 patients to three groups : FLU/FOR ( n = 79 ) , BUD/FOR ( n = 83 ) , and FLU ( n = 81 ) .
RESULTS	In terms of the mean FEV1 after 12 weeks of treatment , the difference between the FLU/FOR and BUD/FOR groups was 0.22 L ( 95 % CI : -0.06 to 0.49 ) , whereas the difference between the FLU/FOR and FLU groups was 0.26 L ( 95 % CI : -0.002 to 0.52 ) .
RESULTS	Non-inferiority was demonstrated by the difference between the lower limits of the two 95 % CIs ( -0.06 vs. -0.002 ) .
RESULTS	The level of asthma control and PEF were significantly greater in the FLU/FOR and BUD/FOR groups than in the FLU group .
RESULTS	There were no significant differences among the groups regarding patient adherence , patient inhaler use , or safety profile of the formulations .
CONCLUSIONS	The single-capsule combination of FLU/FOR showed non-inferiority to the BUD/FOR and FLU formulations regarding efficacy and safety , making it a new treatment option for persistent asthma .

