%0 Journal Article
%T Efficacy and safety of inhaled formoterol 4.5 and 9 ¦Ìg twice daily in Japanese and European COPD patients: Phase III study results
%A Miron A Bogdan
%A Hisamichi Aizawa
%A Yoshinosuke Fukuchi
%A Michiaki Mishima
%A Masaharu Nishimura
%A Masakazu Ichinose
%J BMC Pulmonary Medicine
%D 2011
%I BioMed Central
%R 10.1186/1471-2466-11-51
%X This double-blind, placebo-controlled, parallel-group, multinational phase III study randomized patients ¡Ý 40 years of age with moderate-to-severe COPD to inhaled formoterol 4.5 or 9 ¦Ìg twice daily (bid) via Turbuhaler£¿ or placebo for 12 weeks. Salbutamol 100 ¦Ìg/actuation via pMDI was permitted as reliever medication. The primary outcome variable was change (ratio) from baseline to treatment period in FEV1 60-min post-dose.613 patients received treatment (formoterol 4.5 ¦Ìg n = 206; 9 ¦Ìg n = 199; placebo n = 208); 539 (87.9%) male; 324 (52.9%) Japanese and 289 (47.1%) European. End of study increases in FEV1 60-min post-dose were significantly greater (p < 0.001 for both) with formoterol 4.5 and 9 ¦Ìg bid (113% of baseline for both) than with placebo, as were all secondary outcome measures. The proportion of patients with an improvement in St George's Respiratory Questionnaire score of ¡Ý 4 was 50.2% for formoterol 4.5 ¦Ìg (p = 0.0682 vs. placebo), 59.2% (p = 0.0004) for 9 ¦Ìg, and 41.3% for placebo. Reduction in reliever medication use was significantly greater with formoterol vs. placebo (9 ¦Ìg: -0.548, p < 0.001; 4.5 ¦Ìg: -0.274, p = 0.027), with 9 ¦Ìg being significantly superior to 4.5 ¦Ìg (-0.274, p = 0.029). Formoterol was well tolerated with the incidence and type of adverse events not being different for the three groups.Formoterol 4.5 ¦Ìg and 9 ¦Ìg bid was effective and well tolerated in patients with COPD; there was no difference between formoterol doses for the primary endpoint; however, an added value of formoterol 9 ¦Ìg over 4.5 ¦Ìg bid was observed for some secondary endpoints.NCT00628862 (ClinicalTrials.gov); D5122C00001 (AstraZeneca Study code).Chronic obstructive pulmonary disease (COPD) is a chronic, progressive respiratory disease that follows a course of declining lung function and markedly impaired quality of life, and places patients at a significantly increased risk of premature death [1,2]. The pulmonary component of the disease is characterized by airfl
%U http://www.biomedcentral.com/1471-2466/11/51