التفاصيل البيبلوغرافية
| العنوان: |
Comparison of extrafine beclomethasone dipropionate/formoterol fumarate dry powder inhaler and pressurized metered-dose inhaler in Chinese patients with asthma: the FORTUNE study. |
| المؤلفون: |
Zheng, Jinping1 (AUTHOR), Zhang, Jianyong2 (AUTHOR), Fu, Xiuhua3 (AUTHOR), Lin, Changqing4 (AUTHOR), Zhang, Xinri5 (AUTHOR), Mei, Xiaodong6 (AUTHOR), Corradi, Massimo7 (AUTHOR), Cappellini, Glauco8 (AUTHOR), Calabro, Emanuele8 (AUTHOR), Zhu, Cissy9 (AUTHOR), Topole, Eva8 (AUTHOR) e.topole@chiesi.com |
| المصدر: |
Journal of Asthma. Apr2024, Vol. 61 Issue 4, p360-367. 8p. |
| مصطلحات موضوعية: |
*METERED-dose inhalers, *BECLOMETHASONE dipropionate, *ASTHMATICS, *CHINESE people, *FORMOTEROL |
| مصطلحات جغرافية: |
CHINA |
| مستخلص: |
When selecting inhaled therapies, it is important to consider both the active molecules and the device. Extrafine formulation beclomethasone dipropionate plus formoterol fumarate (BDP/FF) has been available for some years delivered via pressurized metered-dose inhaler (pMDI). More recently, a breath-activated, multi-dose dry-powder inhaler (DPI), the NEXThaler, has been approved. The current study aimed to demonstrate the non-inferiority of BDP/FF delivered via the DPI vs. via the pMDI, in Chinese adults with asthma. After a four-week run-in period, when all patients received BDP/FF pMDI 100/6 µg, two inhalations twice daily (BID), patients were randomized equally to BDP/FF pMDI or DPI, both 100/6 µg, two inhalations BID for 12 weeks. The primary objective was to demonstrate non-inferiority of BDP/FF DPI vs. BDP/FF pMDI in terms of average pre-dose morning peak expiratory flow (PEF) over the entire treatment period. Of 252 and 242 patients in the DPI and pMDI groups, respectively, 88.5% and 88.8% completed the study. The primary objective was met, with no statistically significant difference between the treatments in average pre-dose morning PEF, and with the lower limit of the 95% CI above the −15 L/min non-inferiority margin (adjusted mean difference: 5.25 L/min [95% CI: −0.56, 11.06]). Adverse events were reported by 48.4% and 49.6% patients in the DPI and pMDI groups, respectively, most mild or moderate. The NEXThaler DPI is a similarly effective device to the pMDI for the administration of BDP/FF in adults, so extending the options available for the management of asthma. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
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