Effects of Mometasone Furoate Given Once Daily in the Evening on Lung Function and Symptom Control in Persistent Asthma

• Published in: The Annals of pharmacotherapy 2005-12, Vol.39 (12), p.1977-1983
• Main Authors: Karpel, Jill P, Busse, William W, Noonan, Michael J, Monahan, Mary Ellen, Lutsky, Barry, Staudinger, Heribert
• Format: Article
• Language: English
• Subjects: Administration, Inhalation; Adolescent; Adult; Aged; Albuterol - administration & dosage; Albuterol - therapeutic use; Anti-Inflammatory Agents - administration & dosage; Anti-Inflammatory Agents - adverse effects; Anti-Inflammatory Agents - pharmacology; Asthma - drug therapy; Asthma - physiopathology; Biological and medical sciences; Bronchodilator Agents - administration & dosage; Bronchodilator Agents - therapeutic use; Child; Child, Preschool; Chronic obstructive pulmonary disease, asthma; Double-Blind Method; Female; Humans; Lung - physiopathology; Male; Medical sciences; Middle Aged; Mometasone Furoate; Pharmacology. Drug treatments; Pneumology; Pregnadienediols - administration & dosage; Pregnadienediols - adverse effects; Pregnadienediols - pharmacology; Respiratory Function Tests
• ISSN: 1060-0280; 1542-6270
• DOI: 10.1345/aph.1G410

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 ≥12 years of age with inhaled corticosteroid–dependent asthma and baseline forced expiratory volume in 1 second (FEV1) between 50% and 85% of predicted were randomized to receive treatment with MF-DPI 400 μg once daily in the evening, MF-DPI 200 μg twice daily, or placebo. The primary efficacy variable was mean change in FEV1 from baseline to endpoint. Other lung function measures, asthma symptoms, quality of life, and rescue medication use also were assessed. RESULTS At endpoint, mean FEV1 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 μg once daily in the evening was as effective as MF-DPI 200 μg 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.