RT Journal Article
SR Electronic
T1 Comparison of the efficacy and safety of mometasone furoate dry powder inhaler to budesonide Turbuhaler
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 808
OP 816
DO 10.1183/09031936.00.16580800
VO 16
IS 5
A1 J Bousquet
A1 A D'Urzo
A1 J Hebert
A1 CH Barraza
A1 LP Boulet
A1 R Suarez-Chacon
A1 U Harnest
A1 B Lundback
A1 G Martinez Morales
A1 MM Nieminen
A1 KB Nolop
A1 S Visser
A1 BN Lutsky
YR 2000
UL http://erj.ersjournals.com/content/16/5/808.abstract
AB Mometasone furoate (MF) administered by dry powder inhaler (DPI) was composed with budesonide (BUD) Turbuhaler in the treatment of moderate persistent asthma. The patients were randomized to one of four treatment groups: MF DPI (100, 200, 400 microg b.i.d) or BUD Turbuhaler. 400 microg b.i.d in a 12-week, active-controlled, evaluator-blind, multicentre international trial. The primary efficacy variable was the mean change from baseline to endpoint (last treatment visit) in forced expiratory volume in one second (FEV1). Changes in FEV1 showed a statistically significant superiority (p<0.05) of MF DPI 200 and 400 microg b.i.d compared with the BUD Turbuhaler 400 microg b.i.d treatment. Significant superiority (p<0.05) was also seen in scores for several secondary efficacy variables when MF DPI was compared with BUD Turbuhaler treatment. MF DPI 200 microg b.i.d was comparable to MF DPI 400 microg b.i.d in therapeutic benefit. The incidence of oral candidiasis was no more than 3% in any group. All treatments were well tolerated. A total daily dose of 400 microg of mometasone furoate administered by dry powder inhaler provides a well-tolerated treatment for patients with moderate persistent asthma and results in a significantly greater improvement, when compared to a daily dose of 800 microg BUD Turbuhaler in the parameters measured in this study.