Dose-ranging study of mometasone furoate dry powder inhaler in the treatment of moderate persistent asthma using fluticasone propionate as an active comparator
B. O'Connor et al., Dose-ranging study of mometasone furoate dry powder inhaler in the treatment of moderate persistent asthma using fluticasone propionate as an active comparator, ANN ALLER A, 86(4), 2001, pp. 397-404
Background: Mometasone furoate (MF; Schering-Plough, Madison, NJ), is a glu
cocorticoid with high local potency and low potential systemic availability
.
Objectives: To compare the relative efficacy and safety of a new formulatio
n of MF, coupled with a recently designed dry powder inhaler (DPI), in the
treatment of patients with moderate persistent asthma. Fluticasone propiona
te administered by Diskhaler (FP Diskhaler, 250 mug twice a day; Glare Well
come, Research Triangle Park, NC) was used as an active control.
Design: A randomized, parallel group, double-blind (for MF-DPI dosage), eva
luator-blind (for MF-DPI vs FP) trial.
Setting: Sixty centers in 20 countries.
Patients: Seven hundred thirty-three patients with moderate persistent asth
ma on inhaled corticosteroid treatment. I
nterventions: Discontinuation of previous inhaled corticosteroid and initia
tion of one of four study treatments: three doses of MF-DPI (100, 200, and
400 mug twice daily) and one of FP (250 mug twice daily >12 weeks).
Results: FEV1 (primary efficacy variable) was evaluated as the mean change
from baseline to endpoint (last evaluable visit). All dosage groups showed
improvement at endpoint. Only 400 mug twice daily of MF-DPI (+0.19 L) was s
tatistically different from 100 mug twice daily of MF-DPI (+0.07 L; P = 0.0
2). MF-DPI (200 mug twice daily) and FP Diskhaler groups showed similar imp
rovement (+0.16 L). Greater improvement in most secondary variables (forced
expiratory flow between 25% and 75% of vital capacity, and morning and eve
ning peak expiratory flows) also resulted from treatment with 200 or 400 mu
g twice daily of MF-DPI or with FP Diskhaler, compared with 100 mug twice d
aily of MF-DPI, Overall, a total daily 800-mug dose of MF-DPI conferred no
significant additional benefit >400 mug of MF-DPI. The incidence of oral ca
ndidiasis was 1%, 7%, 10%, and 10% in the 100, 200, and 400 mug twice daily
of MF-DPI and FP groups, respectively.
Conclusions: A total daily dose of 400 mug of MF-DPI provides clinical bene
fit comparable to that observed with a total daily dose of 500 mug of FP Di
skhaler.