Fenton Caroline, Keating Gillian M, Plosker Greg L
Adis International Limited, Auckland, New Zealand.
Drugs. 2003;63(22):2437-45; discussion 2447-8. doi: 10.2165/00003495-200363220-00010.
Novolizer is a multidose breath-actuated dry powder inhaler (DPI) approved for use with salbutamol (albuterol) and budesonide. It has multiple patient feedback mechanisms and an inspiratory flow rate threshold designed to optimise dosage. In two studies, children aged 4-11 years with asthma correctly used Novolizer and generated mean peak inspiratory flow rates (PIFRs) through Novolizer of 76 and 92.7 L/min, well above the Novolizer threshold of 35-50 L/min. In healthy volunteers, median lung deposition of budesonide administered via Novolizer was 19.9-32.1% at mean PIFRs of 54-99 L/min. In a randomised, double-blind, single-dose study in patients with chronic obstructive pulmonary disease (COPD) and asthma, the 1-hour improvement from baseline in mean maximum forced expiratory volume in 1 second (FEV(1)) was 21.3% with inhalation of salbutamol through Novolizer, and 19.5% through Sultanol pressurised metered-dose inhaler (MDI). FEV(1) increased significantly in patients with asthma and COPD treated for 4 weeks in a randomised, open-label comparison of salbutamol through either Novolizer or Sultanol MDI. A randomised open-label study in adults with asthma treated with inhaled budesonide found equivalent improvements in FEV(1) and symptoms with Novolizer and Turbuhaler. Novolizer was well accepted overall. Most patients preferred it to previously used MDIs or DPIs. Only 4-5% found the taste feedback unacceptable. Physicians observed improved compliance over 4 weeks in 80% of patients with asthma using Novolizer.
诺沃利泽是一种多剂量呼吸驱动干粉吸入器(DPI),已获批用于沙丁胺醇(舒喘灵)和布地奈德。它具有多种患者反馈机制以及一个吸气流量阈值,旨在优化剂量。在两项研究中,4至11岁的哮喘儿童正确使用了诺沃利泽,通过该吸入器产生的平均吸气峰流速(PIFR)分别为76升/分钟和92.7升/分钟,远高于诺沃利泽35至50升/分钟的阈值。在健康志愿者中,通过诺沃利泽吸入布地奈德时,在平均PIFR为54至99升/分钟的情况下,肺部沉积中位数为19.9%至32.1%。在一项针对慢性阻塞性肺疾病(COPD)和哮喘患者的随机、双盲、单剂量研究中,通过诺沃利泽吸入沙丁胺醇后,1秒用力呼气量(FEV₁)从基线开始1小时的平均改善率为21.3%,通过苏尔坦诺尔压力定量吸入器(MDI)则为19.5%。在一项通过诺沃利泽或苏尔坦诺尔MDI对沙丁胺醇进行的随机、开放标签比较中,哮喘和COPD患者接受4周治疗后,FEV₁显著增加。一项针对吸入布地奈德治疗的成年哮喘患者的随机开放标签研究发现,使用诺沃利泽和都保,FEV₁和症状改善情况相当。总体而言,诺沃利泽的接受度良好。大多数患者更喜欢它,而不是之前使用的MDI或DPI。只有4%至5%的患者认为味道反馈不可接受。医生观察到,使用诺沃利泽的哮喘患者中,80%在4周内的依从性有所改善。