Beclometasone Dipropionate/Formoterol Fumarate is Similarly Effective to Budesonide/Formoterol Fumarate in Chinese Patients with COPD: The FORSYYN Double-Blind, Randomised Study
| Autor: | Fuqiang Wen, Yanmin Wu, Chunyan Xing, Yingqun Zhu, Yongxing Chen, Xiaodong Mei, Massimo Corradi, Glauco Cappellini, Emanuele Calabro, Sergio Amodio, Cissy Zhu, Dmitry Galkin |
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| Jazyk: | angličtina |
| Rok vydání: | 2024 |
| Předmět: | |
| Zdroj: | COPD, Vol 21, Iss 1 (2024) |
| Druh dokumentu: | article |
| ISSN: | 15412555 1541-2563 1541-2555 |
| DOI: | 10.1080/15412555.2024.2425157 |
| Popis: | The fixed-dose combination of beclometasone dipropionate/formoterol fumarate (BDP/FF) delivered via pressurised metered-dose inhaler (pMDI) has demonstrated efficacy in chronic obstructive pulmonary disease (COPD), in studies predominantly conducted in Caucasian adults. The current study evaluated the efficacy and safety of BDP/FF pMDI in Chinese patients with COPD, as part of registration for COPD in China. This double-blind, double-dummy, randomised, parallel-group study was conducted in patients with COPD of Chinese ethnicity aged ≥40 years. After a 4-week open-label budesonide/formoterol fumarate (BUD/FF) run-in period, patients were randomised to BUD/FF or BDP/FF for 24 weeks. The primary objective was to demonstrate non-inferiority of BDP/FF to BUD/FF in terms of change from baseline in pre-dose morning forced expiratory volume in 1 sec (FEV1) at Week 24 (i.e. the lower 95% CI limit of the difference was above the pre-defined non-inferiority margin of −0.07 L). Of 750 patients randomised (377 BDP/FF; 373 BUD/FF), 87.6% completed the study. The primary endpoint was met in both the per-protocol (adjusted mean difference −0.001 L [95% CI: −0.025, 0.022], non-inferiority p |
| Databáze: | Directory of Open Access Journals |
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