Comparison of once-daily to twice-daily treatment with mometasone furoate dry powder inhaler.
BACKGROUND
Once-daily dosing with an effective inhaled corticosteroid (ICS) would likely enhance compliance and, therefore, aid in the management of asthma.


OBJECTIVE
Several once-daily dosing regimens of mometasone furoate (MF) administered by dry powder inhaler (DPI) were compared with a twice-daily dosing regimen in 286 patients with mild to moderate persistent asthma who were previously being treated with ICS.


METHODS
During a 2-week open-label phase, patients received MF-DPI, 200 microg twice daily. They were then randomized to continue MF-DPI, 200 microg twice-daily treatment or to receive MF-DPI, 200 microg once daily in the morning (AM), 200 microg once daily in the evening (PM), 400 microg once daily AM, or placebo as part of the 12-week, double-blind phase. The primary efficacy variable was the mean change from the baseline to endpoint (last evaluable observation) for FEV1.


RESULTS
Once-daily MF-DPI, 400 microg, AM maintained FEV1, and morning peak expiratory flow rate, FVC, FEF25%-75%, and asthma symptom scores, at levels similar to those for MF-DPI, 200 microg twice daily and significantly better than placebo. Once-daily MF-DPI, 200 microg, PM was effective in maintaining pulmonary function, but was less effective on other efficacy measures. In comparison to the other MF-DPI groups, once-daily MF-DPI, 200 microg, AM was not as effective overall. The incidence of local adverse events, including oral candidiasis, was low with all dosages.


CONCLUSIONS
Once-daily MF-DPI, 400 microg, AM was as effective as MF-DPI, 200 microg twice daily, whereas once-daily MF-DPI, 200 microg, was more effective when administered in the evening compared with morning, for patients receiving ICS therapy. Once-daily dosing offers an effective and convenient treatment that could aid compliance in the treatment of asthma.
Noonan
M
M
Allergy Associates Research, Portland, OR 97213, USA.
Karpel
J P
JP
Bensch
G W
GW
Ramsdell
J W
JW
Webb
D R
DR
Nolop
K B
KB
Lutsky
B N
BN
D000281:Administration, Intranasal; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics; D001249:Asthma / Q000188:drug therapy; D002940:Circadian Rhythm; D003366:Cosyntropin / Q000494:pharmacology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D008297:Male; D000068656:Mometasone Furoate; D011208:Powders; D011244:Pregnadienediols / Q000008:administration & dosage* / Q000493:pharmacokinetics; D012129:Respiratory Function Tests; D013810:Therapeutic Equivalency
D000893:Anti-Inflammatory Agents; D011208:Powders; D011244:Pregnadienediols; D000068656:Mometasone Furoate; D003366:Cosyntropin; D006854:Hydrocortisone