To compare the efficacy and safety of MF-DPI administered once daily in the evening (qd PM) with BUD-DPI administered twice daily (bid) for 8 weeks.
This 8-week, randomized, open-label study compared MF-DPI 400 mcg qd PM with BUD-DPI 400 mcg bid in subjects (N = 178) ≥ 12 years of age with moderate persistent asthma previously maintained on BUD 400 mcg/day or 800 mcg/day. The primary efficacy variable was change from baseline in FEV1 at endpoint. Secondary variables included AM and PM peak expiratory flow (PEF) rates, response to therapy, and subject satisfaction with their inhaler.
Improvements in FEV1 were observed in both treatment groups. At the end of treatment, the mean change from baseline in FEV1 was 0.23 L (8.6%) with MF-DPI and 0.17 L (6.4%) with BUD-DPI (p = 0.307; 1-sided 95% CI, lower bound: -1.7%). No significant differences were observed in AM or PM PEF responses between the two treatment groups. Greater proportions of subjects in the MF-DPI group were rated by physicians as “improved” or “much improved” compared with the BUD-DPI group at Week 2 (62% vs 39%, respectively; p = 0.014) and Week 4 (67% vs 47%, respectively; p = 0.010). A significantly greater proportion of subjects in the MF-DPI group “liked the inhaler a lot” compared with subjects in the BUD-DPI group who “liked the inhaler a lot” (45% vs 22%, respectively; p = 0.016). Both treatments were well tolerated.
Once-daily treatment with MF-DPI (400 mcg qd PM; one puff/day) was as effective as twice-daily treatment with BUD-DPI (400 mcg bid) in moderate persistent asthma previously treated with BUD.
MF-DPI maintains effective asthma control in patients whose asthma previously was controlled with BUD.
A. D’Urzo, Integrated Therapeutics Group