Dhillon Sohita, Keating Gillian M
Adis International Limited, Mairangi Bay, Auckland, New Zealand.
Drugs. 2006;66(11):1475-83; discussion 1484-5. doi: 10.2165/00003495-200666110-00005.
A hydrofluoroalkane (HFA)-propelled pressurised metered-dose inhaler (pMDI) has been developed (using Modulite technology) for a new fixed combination of beclometasone dipropionate/formoterol fumarate (BDP/formoterol) 100 microg/6 microg. Each actuation of the BDP/formoterol HFA pMDI 100 microg/6 microg delivers 86.4 microg of BDP and 5 microg of formoterol. BDP/formoterol HFA pMDI was associated with significantly higher morning peak expiratory flow (PEF) values than BDP administered alone via a chlorofluorocarbon (CFC) pMDI (including when BDP was administered at a higher dosage) in well designed trials in adults with mild to moderate or moderate to severe asthma. In terms of morning PEF values, BDP/formoterol HFA pMDI was noninferior to BDP plus formoterol administered via separate inhalers in well designed trials in adults with moderate to severe asthma. BDP/formoterol HFA pMDI was noninferior to fixed-combination budesonide/formoterol (the daily dosage of BDP was half that of budesonide) in terms of lung function, asthma symptoms and use of rescue medications in adults with moderate to severe asthma. BDP/formoterol HFA pMDI was also noninferior to, and had a faster onset of bronchodilation than, fixed-combination fluticasone propionate/salmeterol. BDP/formoterol 200 microg/12 microg per day or 400 microg/24 microg per day administered by the HFA pMDI was generally well tolerated. Moreover, a single high dose of BDP/formoterol (1000 microg/60 microg) was generally well tolerated in patients with asthma.
已研发出一种氢氟烷烃（HFA）驱动的压力定量吸入器（pMDI）（采用模块化技术），用于丙酸倍氯米松/富马酸福莫特罗（BDP/福莫特罗）100微克/6微克的新型固定复方制剂。BDP/福莫特罗HFA pMDI 100微克/6微克每次吸入可递送86.4微克BDP和5微克福莫特罗。在针对轻度至中度或中度至重度哮喘成人患者的精心设计试验中，BDP/福莫特罗HFA pMDI的晨间呼气峰值流速（PEF）值显著高于单独通过氯氟烃（CFC）pMDI使用BDP时（包括BDP以更高剂量给药时）。就晨间PEF值而言，在针对中度至重度哮喘成人患者的精心设计试验中，BDP/福莫特罗HFA pMDI不劣于通过单独吸入器使用BDP加福莫特罗的情况。在中度至重度哮喘成人患者的肺功能、哮喘症状及急救药物使用方面，BDP/福莫特罗HFA pMDI不劣于布地奈德/福莫特罗固定复方制剂（BDP的日剂量为布地奈德的一半）。BDP/福莫特罗HFA pMDI在支气管扩张起效速度方面也不劣于丙酸氟替卡松/沙美特罗固定复方制剂，并具有更快的起效速度。通过HFA pMDI给予的每日1次BDP/福莫特罗200微克/12微克或400微克/24微克一般耐受性良好。此外,哮喘患者对单次高剂量的BDP/福莫特罗（1000微克/60微克）通常也耐受性良好。
