Background: Mometasone furoate (MF) is a new potent corticosteroid for use
in treating asthma.
Objective: To test the lower range of the dose-response curve, effects of M
F delivered by dry ponder inhaler (DPI) AMP-induced bronchoconstriction wer
e compared with those of placebo.
Methods: In a placebo-controlled, 3-phase cross-over, single-center, double
-blind study, 15 patients with mild asthma were randomized to three 2-week
treatment phases (separated by 4-week washout phases) with MF DPI 50 mu g t
wice daily, MF DPI 100 mu g twice daily, or placebo. AMP challenge was perf
ormed before and at the end of each treatment phase.
Results: Thirteen patients completed all 3 phases and were included in the
primary efficacy analysis. Treatment with MF DPI 50 mu g twice daily or wit
h MF DPI 100 mu g twice daily significantly reduced the bronchoconstrictor
response to AMP, displacing the dose-response curve to the right by 2.81 an
d 3.11 doubling dilutions, respectively, compared with placebo (P < .0001).
The improvement in FEV1 over the 2-week treatment phase was significantly
(P less than or equal to .033) greater during treatment with MF DPI 50 mu g
or 100 mu g twice daily then with placebo. Peak expiratory flow rate, whee
zing scores, difficulty breathing scores. nocturnal awakenings requiring sa
lbutamol, and puffs of salbutamol per day also indicated a greater improvem
ent in respiratory function and symptoms of asthma with MF DPI 50 or 100 mu
g twice daily than with placebo. Both doses of MF DPL were well tolerated.
Conclusions: Treatment Kith low doses of MF DPI decreased airway responsive
ness to AMP challenge and improved secondary measures of pulmonary function
and asthma symptoms.