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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.

Author(s): Weinstein SF, Corren J, Murphy K, Nolte H, White M; Study Investigators of P04431.

Collaborators: Defranchi HA, Maspero JF, Perez Chada D, Tanco SM, Dimitrov V, Georgiev O, Georgieve PN, Ilieva-Fartunova V, Zagora S, Ivanova G, Kissiova K, Kostow K, Marinov R, Markova N, Metev H, Popov D, Herbert J, Yang W, Chernilo S, Fernandez P, Gutierrez M, Del Mar V, Arciniegas JG, Orozco A, Serrano F, Backer V, Bueso A, Lorazo I, Balint B, Barkai L, Herjavecz I, Kosa L, Mark Z, Mohacsi E, Namenyi M, Nekam K, Panczel G, Schlezak J, Szalai Z, Vinkler I, Guerra F, Matsuno A, Salazar D, Bobrowska-Korzeniowska M, Bodzenta-Lukaszyk A, Bukowczan Z, Chazan R, Kowalski M, Kuna P, Kus J, Pulka G, Rogala B, Sciborski R, Springer E, Szelerska-Twardosz H, Wojnowski P, Astafieva N, Bart B, Emelyanov A, Esina A, Gorelov A, Goryachkina L, Iljina N, Khokhlov A, Klimko N, Komlev A, Korovina O, Sobchenko S, Trofimov V, Vertkin A, Vizel A, Biloglazov V, Crimea SA, Dziublyk O, Feshchenko Y, Gavrysyuk V, Gorovenko N, Kostromina V, Lapshyn V, Lysenko I, Melnyk V, Monogarova N, Nedelskaya S, Okhotnikova O, Pertseva T, Soldatchenko S, Crimea YA, Volosovets O, Yashyna L, Ayars G, Bardelas J, Bensch G, Bernstein D, Carter P, Corren J, Galant S, Goldstein M, Hsu YL, Karpel J, Kerwin E, Levy D, Murphy K, Nayak A, Pleskow Encinitas WW, Tarpay M, Weinstein S, White M, Wolfe J.

Affiliation(s): Allergy and Asthma Specialists Medical Group, Huntington Beach, Californai 92647, USA. sfw@ocallergy.com

Publication date & source: 2010, Allergy Asthma Proc. , 31(4):280-9

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 microg versus MF 400 microg 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 (>or=12 years of age) were randomized to MF/F 200/10 microg, MF/F 400/10 microg, or MF 400 microg, b.i.d. after a 2- to 3-week open-label run in with MF 400 microg 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 (FEV(1) AUC(0-12h)) from baseline to week 12 for MF/F 400/10 microg versus MF 400 microg. 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 FEV(1) AUC(0-12h) with MF/F 400/10 microg (4.19 L x hour) versus MF 400 microg (2.04 L x 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 beta(2)-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.

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