Mometasone furoate (MF; Schering-Plough, Madison, NJ), is a glucocorticoid with high
local potency and low potential systemic availability.
To compare the relative efficacy and safety of a new formulation of MF, coupled with
a recently designed dry powder inhaler (DPI), in the treatment of patients with moderate
persistent asthma. Fluticasone propionate administered by Diskhaler (FP Diskhaler,
250 microg twice a day; Glaxo Wellcome, Research Triangle Park, NC) was used as an
active control.
A randomized, parallel group, double-blind (for MF-DPI dosage), evaluator-blind (for
MF-DPI vs FP) trial.
Sixty centers in 20 countries.
Seven hundred thirty-three patients with moderate persistent asthma on inhaled corticosteroid
treatment.
Discontinuation of previous inhaled corticosteroid and initiation of one of four study
treatments: three doses of MF-DPI (100, 200, and 400 microg twice daily) and one of
FP (250 microg twice daily >12 weeks).
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 microg twice daily of MF-DPI (+0.19 L) was statistically different from 100
microg twice daily of MF-DPI (+0.07 L; P = 0.02). MF-DPI (200 microg twice daily)
and FP Diskhaler groups showed similar improvement (+0.16 L). Greater improvement
in most secondary variables (forced expiratory flow between 25% and 75% of vital capacity,
and morning and evening peak expiratory flows) also resulted from treatment with 200
or 400 microg twice daily of MF-DPI or with FP Diskhaler, compared with 100 microg
twice daily of MF-DPI. Overall, a total daily 800-microg dose of MF-DPI conferred
no significant additional benefit >400 microg of MF-DPI. The incidence of oral candidiasis
was 1%, 7%, 10%, and 10% in the 100, 200, and 400 microg twice daily of MF-DPI and
FP groups, respectively.
A total daily dose of 400 microg of MF-DPI provides clinical benefit comparable to
that observed with a total daily dose of 500 microg of FP Diskhaler.