The Novolizer: a multidose dry powder inhaler.

Abstract

The Novolizer is a multidose, refillable, breath-actuated dry powder inhaler that delivers up to 200 metered doses of drug from a single cartridge. It has a multiple-feedback control mechanism to ensure that the inhalation was performed correctly. In randomized studies, almost all patients with asthma or COPD using the Novolizer, including those using the device for the first time and children, were able to generate sufficient peak inspiratory flow rates (PIFRs) to overcome the trigger threshold of the device. Comparative studies have shown that patients generate significantly higher PIFR through the Novolizer than through the Turbuhaler. At PIFR of 54-99 L/min through the Novolizer, the median deposition of budesonide in the lungs of healthy volunteers was 19.9-32.1%. Two randomized, double-blind trials in patients with asthma showed that the clinical efficacy of drugs delivered through the Novolizer in terms of improvement in FEV(1) was at least as good as that of an identical treatment regimen delivered through the Aerolizer (for formoterol) or the Sultanol (for albuterol [salbutamol]). Similarly, therapeutic equivalence was also shown between budesonide delivered through the Novolizer and that through the Turbuhaler in patients with COPD or asthma in a randomized, nonblind study. Device-related adverse events were not reported in patients using the Novolizer in therapeutic trials and in a large (n > 3000) post-marketing surveillance study. Overall, the Novolizer was well accepted, with an improved compliance in 80% of patients that was attributable to the control mechanisms of the device.