Mometasone furoate: efficacy and safety in moderate asthma compared with beclomethasone dipropionate.
BACKGROUND
Mometasone furoate (MF) is a new inhaled glucocorticoid administered by dry powder inhaler (DPI).


OBJECTIVE
MF-DPI was evaluated for safety and efficacy and compared with placebo DPI and beclomethasone dipropionate (BDP) administered by metered dose inhaler (MDI) in the treatment of patients with moderate persistent asthma.


METHODS
Eligible patients (n = 227), 13 to 75 years of age, maintained on inhaled glucocorticoids before entering the trial, were randomized to receive: MF-DPI, 100 microg, twice daily, MF-DPI, 200 microg, twice daily, BDP MDI, 168 microg, twice daily, or placebo in a 12-week, multicenter, double-blind study.


RESULTS
At endpoint, FEV1 (primary efficacy variable) significantly improved for all three active treatments compared with placebo (P < .01, all comparisons). The response to MF-DPI, 200 microg, twice daily treatment was approximately twice as large as the response to MF-DPI, 100 microg, twice daily or BDP MDI treatment, although the differences between these groups did not reach statistical significance. Secondary efficacy variables including PEFR, asthma symptoms, nocturnal awakenings, and albuterol use showed similar trends. The MF-DPI, 100 microg, twice daily and BDP MDI, 168 microg, twice daily treatment groups produced comparable results for all efficacy variables.


CONCLUSIONS
MF-DPI, 100 microg and 200 microg, twice daily were well-tolerated and significantly improved lung function and symptom control in the treatment of patients with moderate persistent asthma. In this study, MF-DPI, 200 microg, twice daily seemed to be the most effective dosage.
Nathan
R A
RA
Asthma and Allergy Associates, PC, Colorado Springs 80907, USA. DRRNATHAN@aol.com
Nayak
A S
AS
Graft
D F
DF
Lawrence
M
M
Picone
F J
FJ
Ahmed
T
T
Wolfe
J
J
Vanderwalker
M L
ML
Nolop
K B
KB
Harrison
J E
JE
D000280:Administration, Inhalation; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D001249:Asthma / Q000188:drug therapy*; D001507:Beclomethasone / Q000008:administration & dosage / Q000493:pharmacokinetics; D004311:Double-Blind Method; D005541:Forced Expiratory Volume; D005938:Glucocorticoids; D006801:Humans; D008297:Male; D008875:Middle Aged; D000068656:Mometasone Furoate; D010366:Peak Expiratory Flow Rate; D011208:Powders; D011244:Pregnadienediols / Q000008:administration & dosage / Q000493:pharmacokinetics; D013810:Therapeutic Equivalency
D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D011208:Powders; D011244:Pregnadienediols; D000068656:Mometasone Furoate; D001507:Beclomethasone