Comparison of once-daily mometasone furoate versus once-daily budesonide in patients with moderate persistent asthma.
We conducted this study to compare the efficacy and safety of once-daily mometasone furoate (MF) administered by dry powder inhaler (DPI) with once-daily budesonide (BUD)-DPI and placebo in patients with moderate persistent asthma previously using twice-daily inhaled corticosteroids. A total of 262 patients (> or = 12 years of age) with moderate persistent asthma were randomised to once-daily morning treatment with MF-DPI 440 microg (metered dose), BUD-DPI 400 microg (metered dose), or placebo in an eight-week, multicentre, placebo-controlled, double-blind, double-dummy study. The primary efficacy variable was percent change in FEV1 from baseline to endpoint (last evaluable visit). At endpoint, the percent change in FEV1 was significantly greater (p < 0.01) following treatment with MF-DPI 440 microg (8.9%) than with both BUD-DPI 400 microg (2.1%) and placebo (-3.9%). Secondary efficacy variables, including morning and evening peak expiratory flow rates, albuterol use, percentage of asthma symptom-free days, and physician-evaluated response to therapy were also significantly improved at endpoint in the MF-DPI group compared with both the placebo and BUD-DPI groups (p < 0.05). Both active treatments were well tolerated. In conclusion, once-daily treatment in the morning with MF-DPI 440 microg significantly improved pulmonary function and asthma control compared with morning administration of BUD-DPI 400 microg and placebo.
Corren
J
J
Allergy Research Foundation, Los Angeles, California 90025, USA.
Berkowitz
R
R
Murray
J J
JJ
Prenner
B
B
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D019819:Budesonide / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008875:Middle Aged; D000068656:Mometasone Furoate; D011244:Pregnadienediols / Q000008:administration & dosage*; D012129:Respiratory Function Tests; D016896:Treatment Outcome
D018927:Anti-Asthmatic Agents; D000893:Anti-Inflammatory Agents; D011244:Pregnadienediols; D000068656:Mometasone Furoate; D019819:Budesonide