Twenty-six-week efficacy and safety study of mometasone furoate/formoterol 200/10 microg combination treatment in patients with persistent asthma previously receiving medium-dose inhaled corticosteroids.
Cheema A, Hebert J, Sussman G, Yang W, Cardona-Arango G, Giraldo-Estrada H, Matiz-Bueno CE, Cheng WC, Jimenez EG, Mitchell Brumley TA, Ahel V, Caleta D, Cepin-Bogovic J, Pavicic F, Stipic-Markovic A, Tudoric N, Backer V, Doessing M, Cherrez Ojeda MI, Jogi R, Nagelmann A, Samaruutel P, Chur Gonzalez VH, Flores Belteton MV, Guerra Mejia JS, Balint B, Barkai L, Kosa L, Mark Z, Mohacsi E, Nekam K, Panczel G, Schlezak J, Szalai Z, Vinkler I, Bajpai A, Bhargava S, Christopher D, D'Souza GA, Kale M, Kant S, Kumar RV, Niphadkar P, Rajan S, Rao M, Saboo S, Sahasrabudhe T, Sarnaik RM, Talwar D, Waghray P, Aguilar Dominguez PE, Hernandez-Colin DD, Rendon-Perez LA, Sanchez Llamas F, Atienza T, Balgos A, Carlos G, de Guia T, Diaz D, Roa C, Santiaguel J, Siasoco MB, Bobrowska-Korzeniowska M, Bukowczan Z, Chazan R, Jutel M, Kuklinska B, Kuna P, Pierzchala W, Pulka G, Rogala B, Sciborski R, Springer E, Stelmach I, Szelerska-Twardosz H, Chardon-Feliciano D, Rodriguez-Santana JR, Astafyeva N, Emelyanov A, Gorelov A, Goryachkina L, IIjina N, Klimko N, Korovina O, Trofimov V, Vertkin A, Vizel A, Direkwattanachai C, Jatakanon A, Nana A, Viriyachaiyo V, Yai H, Biloglazov V, Crimea SA, Dziublyk O, Feshchenko Y, Gavrysyuk V, Gorovenko N, Lysenko I, Monogarova N, Pertseva T, Soldatchenko S, Crimea YA, Yashyna L, Amar N, Ayars G, Bensch G, Berger W, Bernstein D, Campbell EJ, Carter P, Corren J, Diaz J, DuBuske L, Ford L, Friedman B, Gawchick SM, Girgis K, Gottschlich G, Greos L, Gross G, Hampel F Jr, Heller A, Kaiser H, Kao N, Kerwin E, LaForce CF, Lane E, Levy D, Lumry W, Mansfield LE, Meltzer E, Meltzer SM, Miller SD, Murphy K, Nathan RA, Nayak A, Nilsson T, Noonan M, Olson G, Pearle J, Pedinoff A, Pearlman D, Pleskow W, Prenner B, Raphael G, Ratner P, Sher L, Soong W, Tarpay M, Weakley S, Weinstein S, White M, Wolfe J, Wolfe R.
Source
Asthma and Allergy Associates and Research Center, Colorado Springs, Colorado 80907, USA. drrnathan@aol.com
Abstract
Asthma is a heterogeneous condition characterized by reduced lung function, chronic inflammation, and periodic asthma deteriorations. This study was performed to evaluate the effect of mometasone furoate (MF)/formoterol (F) combination, 200/10 microg, administered twice daily (b.i.d.) on asthma deteriorations and pulmonary function in patients with asthma uncontrolled on medium-dose inhaled corticosteroid (ICS). After 2- to 3-week open-label run-in with MF 200 microg b.i.d., patients (>or=12 years) were randomized to 26 weeks of treatment with MF/F 200/10 microg, MF 200 microg, F 10 microg, or placebo b.i.d. Coprimary end points were time to first asthma deterioration (MF/F versus F) and bronchodilation, assessed by the area under the curve of the change in forced expiratory volume in 1 second 0-12 hours (FEV(1) AUC(0-12h); MF/F versus MF). A total of 781 patients were randomized. Treatment with MF/F 200/10 microg reduced asthma deteriorations and clinically judged deteriorations (i.e., deterioration resulting in emergency treatment, hospitalization, or treatment with additional excluded asthma medication [i.e., systemic corticosteroids]). The proportion of patients experiencing asthma deteriorations was MF/F, 30.4%; MF, 33.9%; F, 54.0%; placebo, 55.6% (p < 0.001, MF/F versus F and placebo). There was a sixfold reduction in clinically judged deteriorations with MF/F versus F and placebo (p < 0.001). Lung function improved more rapidly with MF/F than MF and placebo. Mean change from baseline FEV(1) AUC(0-12h) at week 12 was MF/F, 11.7% versus MF, 5.7%; F, 8.5%; and placebo, 3.9% (p < 0.001). Treatment-related AEs were rare and similar across groups. Treatment with MF/F 200/10 microg was effective in reducing the risk of asthma deteriorations. MF/F was safe and provided rapid and sustained bronchodilation in patients with asthma.
- PMID:
- 20678306
- [PubMed - indexed for MEDLINE]
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