RT Journal Article
SR Electronic
T1 A double-blind, double-dummy, randomized study of beclomethasone/formoterol versus fluticasone/salmeterol in treatment of moderate to severe asthma in Taiwan
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P4120
VO 42
IS Suppl 57
A1 Meng-Jer Hsieh
A1 Ruay-Sheng Lai
A1 Chien-Liang Wu
A1 Chun-Liang Lai
A1 Chin-Chou Wang
A1 Dian-Wang Peng
A1 Ying-Huang Tsai
YR 2013
UL http://erj.ersjournals.com/content/42/Suppl_57/P4120.abstract
AB Background Inadequate asthma control by ICS alone asks for the combination with LABA, and the extrafine formulation of BDP/F allows 2.5-fold lower dose of BDP to achieve the same efficacy. This study compared the efficacy, safety and tolerability of BDP/F with those of FP/S in patients with moderate to severe asthma.Objective To show that the onset action of BDP/F was superior to that of FP/S in patients with moderate to severe asthma.Methods: This was a double-blind, double-dummy, randomized, multicenter study. A total of 253 patients whose asthma was not adequately controlled after 2-week run-in period were randomized to receive BDP/F or FP/S treatment for 12 weeks.Results The superiority of BDP/F over FP/S in the change from baseline pre-dose FEV1 to week 12 post-dose 5-min FEV1 was not demonstrated in this study (BDP/F: 0.20L, FP/S: 0.14L; p>0.05). FEV1 and FVC increased significantly immediately after inhalation of BDP/F (from 5 min). Similar results were found in the FP/S group in terms of FEV1, but FVC did not improve significantly until 30 min after inhalation of FP/S. Patients who received BDP/F showed significantly higher improvements in FEV1 and FVC at post-dose 5 min as compared with those who received FP/S. Both groups showed comparable results in PEF, asthma control rate and use of rescue medication.Conclusions BDP/F was as efficacious as FP/S in improving pulmonary function, PEF, and asthma control. Furthermore, a trend of more rapid onset of action was found in the BDP/F group. The safety profile showed that both BDP/F and FP/S were well-tolerate in Taiwanese patients with moderate to severe asthma.