Effects of mometasone furoate given once daily in the evening on lung function and symptom control in persistent asthma.
BACKGROUND
The chronobiology of asthma suggests that, for once-daily dosing, an evening dose may be the most effective treatment paradigm.


OBJECTIVE
To evaluate the efficacy and safety of mometasone furoate dry powder inhaler (MF-DPI) administered once daily in the evening or twice daily in patients with asthma previously maintained on twice-daily regimens of inhaled corticosteroids.


METHODS
In this 12-week, multicenter, placebo-controlled trial, 268 subjects > or =12 years of age with inhaled corticosteroid-dependent asthma and baseline forced expiratory volume in 1 second (FEV(1)) between 50% and 85% of predicted were randomized to receive treatment with MF-DPI 400 mug once daily in the evening, MF-DPI 200 mug twice daily, or placebo. The primary efficacy variable was mean change in FEV(1) from baseline to endpoint. Other lung function measures, asthma symptoms, quality of life, and rescue medication use also were assessed.


RESULTS
At endpoint, mean FEV(1) was significantly improved with both MF-DPI doses compared with placebo (p < 0.001). The 2 active treatment groups were statistically indistinguishable from each other. Secondary efficacy variables, including nocturnal awakenings, asthma worsenings, quality of life, and rescue medication use, were also significantly improved for both MF-DPI treatments compared with placebo. Both dosages were well tolerated; no clinically meaningful changes in laboratory values or vital signs were observed.


CONCLUSIONS
MF-DPI 400 mug once daily in the evening was as effective as MF-DPI 200 mug twice daily in improving pulmonary function, asthma symptoms, and quality of life compared with placebo in subjects previously using twice-daily regimens of an inhaled corticosteroid.
Karpel
Jill P
JP
Albert Einstein College of Medicine, Beth Thalheim Asthma Center, North Shore-Long Island Jewish Health System, New Hyde Park, NY 11040, USA. jpkarpel@aol.com
Busse
William W
WW
Noonan
Michael J
MJ
Monahan
Mary Ellen
ME
Lutsky
Barry
B
Staudinger
Heribert
H
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology*; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008168:Lung / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged; D000068656:Mometasone Furoate; D011244:Pregnadienediols / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D012129:Respiratory Function Tests
D000893:Anti-Inflammatory Agents; D001993:Bronchodilator Agents; D011244:Pregnadienediols; D000068656:Mometasone Furoate; D000420:Albuterol