Comparison of mometasone furoate administered by metered dose inhaler with beclomethasone dipropionate.
This study compared the efficacy and safety of mometasone furoate (MF) administered by metered dose inhaler (MDI) 56, 200 or 500 pg b.i.d., with beclomethasone dipropionate (BDP) 168 microg b.i.d. and placebo. Adult patients (n=395), with moderate persistent asthma (FEV1 50-90% of predicted normal), previously maintained on inhaled corticosteroids, were enrolled at 16 centres in a four-week, randomised, double-blind, double-dummy, multicentre, dose-ranging trial. At endpoint, FEV1 was significantly improved (p<0.01) with MF-MDI 56, 200 and 500 microg b.i.d., as well as with BDP (6%, 13%, 14% and 4%, respectively), compared with placebo (-12%). Mean change in FVC, FEF2575%, and a.m. and p.m. peak expiratory flow rate (PEFR) were also significantly improved for all active treatment groups at endpoint compared with placebo. Asthma symptoms and quality of life (SF-36) related to physical functioning improved with active treatments relative to placebo. All doses of MF-MDI were well tolerated. Treatment with MF-MDI 200 pg b.i.d. was superior to BDP MDI 168 microg b.i.d. or MF-MDI 56 microg b.i.d., with no additional benefit derived from a higher MF-MDI 500 microg b.i.d. dose. MF-MDI was well tolerated, with superior efficacy compared with BDP MDI in these patients with moderate persistent asthma.
Chervinsky
P
P
New England Clinical Studies, Dartmouth, Massachusetts, USA.
Nelson
H S
HS
Bernstein
D I
DI
Berkowitz
R A
RA
Siegel
S C
SC
D000293:Adolescent; D000328:Adult; D000368:Aged; D001249:Asthma / Q000188:drug therapy*; D001507:Beclomethasone / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D016503:Drug Delivery Systems; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D000068656:Mometasone Furoate; D009330:Nebulizers and Vaporizers; D011244:Pregnadienediols / Q000008:administration & dosage* / Q000627:therapeutic use; D011788:Quality of Life; D012129:Respiratory Function Tests
D005938:Glucocorticoids; D011244:Pregnadienediols; D000068656:Mometasone Furoate; D001507:Beclomethasone