哮喘是一种常见的慢性呼吸系统疾病,以气道炎症和平滑肌收缩(支气管收缩)为主要特征,可导致呼吸困难1 。
近期,阿斯利康宣布,两项III期KALOS与LOGOS研究表明其固定三联吸入制剂:布地格福吸入气雾剂(320/28.8/9.6μg)达到主要终点,在患者肺功能改善方面具有显著统计学意义与临床意义。
KALOS与LOGOS为重复、随机、双盲试验,旨在将布地格福吸入气雾剂作为一项潜在的哮喘治疗方法进行研究5,6。这些试验评估了布地格福吸入气雾剂对比ICS/LABA维持治疗在未得到控制的成人和青少年哮喘患者中的有效性与安全性5,6。
阿斯利康全球执行副总裁,生物制药研发负责人Sharon Barr表示:“这些结果表明布地格福吸入气雾剂有助于改善数百万哮喘患者的生活。我们期待与监管部门分享这些研究结果,使布地格福吸入气雾剂能够惠及更广泛的患者群体。”
参考文献
- Global Asthma Network. The Global Asthma Report 2022. [Online]. Available at: http://globalasthmareport.org/resources/Global_Asthma_Report_2022.pdf. [Last accessed: May 2025].
- Davis J, et al. Burden of asthma among patients adherent to ICS/LABA: A real-world study. J Asthma. 2019 Mar;56(3):332-340.
- Buhl R, et al. One-year follow up of asthmatic patients newly initiated on treatment with medium- or high-dose inhaled corticosteroid-long-acting β2-agonist in UK primary care settings. Respir Med. 2020 Feb: 162:105859.
- Huang K,et al.Lancet. 2019 Aug 3;394(10196)407-418.
- gov. Study to Assess PT010 in Adult and Adolescent Participants with Inadequately Controlled Asthma (KALOS) [Online]. Available at: https://clinicaltrials.gov/study/NCT04609878?limit=25&term=KALOS&rank=1. [Last accessed: May 2025].
- gov. Study to Assess PT010 in Adult and Adolescent Participants with Inadequately Controlled Asthma (LOGOS) [Online]. Available at: https://clinicaltrials.gov/study/NCT04609904?limit=25&term=LOGOS&rank=4. [Last accessed: Mayl 2025].