[Clinical study concerning anti-inflammatory effect of fixed dose therapy by budesonide/formoterol combination inhaler for moderate persistent asthmatics].

BACKGROUND

The clinical usefulness of fixed dose maintenance therapy using a combination inhaler containing budesonide and formoterol (FBC) has already been established, still evidence concerning anti-inflammatory effect by maintenance therapy with fix-dosed FBC, in comparison with other ICS and LABA combination therapy including salmeterol/fluticasone combination inhaler, is lacking.

METHODS

Moderate persistent adult asthmatics who has received combination therapy of ICS (200∼500 μg/day FP equivalent) and LABA (salmeterol 100 μg/day) for more than 6 months and under well-control conditions by asthma control test (ACT) have been recruited. FeNO, as a marker of airway inflammation, ACT score, and the results of spirometry have been evaluated after switching to maintenance therapy by FBC 640/18 μg/day for 8 weeks.

RESULTS

The fixed dosed FBC therapy resulted in superior primary outcome, as compared with previous ICS/LABA combination therapy, as assessed by measuring FeNO, 44.0±26.5 to 31.3± 15.4 ppb (p<0.01, paired-t test). ACT score also improved significantly, 22.22±1.57 to 23.88±1.57 (p<0.01). The number of patients who used SABA more than once a week has decreased 13 to 0 with FBC treatment.

CONCLUSION

The airway anti-inflammatory effect by 8 weeks maintenance therapy with fix-dosed FBC 640/18 μg/day (2 puffs twice a day) has been strongly suggested.