Twelve-week efficacy and safety study of mometasone furoate/formoterol 200/10 microg and 400/10 microg combination treatments in patients with persistent asthma previously receiving high-dose inhaled corticosteroids

TY - JOUR

T1 - Twelve-week efficacy and safety study of mometasone furoate/formoterol 200/10 microg and 400/10 microg combination treatments in patients with persistent asthma previously receiving high-dose inhaled corticosteroids

AU - Weinstein, Steven F

AU - Corren, Jonathan

AU - Murphy, Kevin

AU - Nolte, Hendrik

AU - White, Martha

AU - Study Investigators of P04431

AU - Backer, Vibeke

PY - 2010/7/1

Y1 - 2010/7/1

N2 - A significant unmet medical need exists in patients with uncontrolled asthma. The purpose of this study was to evaluate the efficacy and safety of mometasone furoate/formoterol (MF/F) 400/10 μg versus MF 400 μg administered twice-daily (b.i.d.) via metered-dose inhaler in patients with asthma uncontrolled on high-dose inhaled corticosteroids (ICS). In a 12-week, randomized, multicenter, double-blind, parallel-group study, patients (≥12 years of age) were randomized to MF/F 200/10 μg, MF/F 400/10 μg, or MF 400 μg, b.i.d. after a 2- to 3-week open-label run in with MF 400 μg b.i.d. The primary end point was mean change in area under the curve from 0 to 12 hours in forced expiratory volume in 1 second (FEV1 AUC0-12h) from baseline to week 12 for MF/F 400/10 μg versus MF 400 μg. Effects of MF/F on asthma control and symptoms were evaluated and adverse events recorded. Seven hundred twenty-eight patients were randomized. Significant improvement from baseline to week 12 occurred for mean change in FEV1 AUC 0-12h with MF/F 400/10 μg (4.19 L × hour) versus MF 400 μg (2.04 L × hour; p < 0.001). Both MF/F doses resulted in rapid (5 minutes) and sustained improvement in lung function throughout 12 weeks. Both MF/F doses were superior to MF in improving asthma control and reducing nocturnal awakenings due to asthma requiring short-acting β2- agonist use. All treatments were well tolerated. Asthma patients who were poorly controlled on high-dose ICS experienced significant improvement in asthma control, lung function, and symptoms when treated with MF/F compared with MF.

AB - A significant unmet medical need exists in patients with uncontrolled asthma. The purpose of this study was to evaluate the efficacy and safety of mometasone furoate/formoterol (MF/F) 400/10 μg versus MF 400 μg administered twice-daily (b.i.d.) via metered-dose inhaler in patients with asthma uncontrolled on high-dose inhaled corticosteroids (ICS). In a 12-week, randomized, multicenter, double-blind, parallel-group study, patients (≥12 years of age) were randomized to MF/F 200/10 μg, MF/F 400/10 μg, or MF 400 μg, b.i.d. after a 2- to 3-week open-label run in with MF 400 μg b.i.d. The primary end point was mean change in area under the curve from 0 to 12 hours in forced expiratory volume in 1 second (FEV1 AUC0-12h) from baseline to week 12 for MF/F 400/10 μg versus MF 400 μg. Effects of MF/F on asthma control and symptoms were evaluated and adverse events recorded. Seven hundred twenty-eight patients were randomized. Significant improvement from baseline to week 12 occurred for mean change in FEV1 AUC 0-12h with MF/F 400/10 μg (4.19 L × hour) versus MF 400 μg (2.04 L × hour; p < 0.001). Both MF/F doses resulted in rapid (5 minutes) and sustained improvement in lung function throughout 12 weeks. Both MF/F doses were superior to MF in improving asthma control and reducing nocturnal awakenings due to asthma requiring short-acting β2- agonist use. All treatments were well tolerated. Asthma patients who were poorly controlled on high-dose ICS experienced significant improvement in asthma control, lung function, and symptoms when treated with MF/F compared with MF.

U2 - 10.2500/aap.2010.31.3381

DO - 10.2500/aap.2010.31.3381

M3 - Journal article

SN - 1088-5412

VL - 31

SP - 280

EP - 289

JO - Allergy and Asthma Proceedings

JF - Allergy and Asthma Proceedings

IS - 4

ER -