Efficacy and safety of formoterol delivered through the Novolizer®, a novel dry powder inhaler (DPI) compared with a standard DPI in patients with moderate to severe asthma

Background & objectiveBecause of environmental concerns CFC-containing pressurised metered dose inhalers (pMDI) had to be replaced by dry powder inhalers (DPI). The Novolizer®, a novel DPI has previously been shown to be as effective as the Turbuhaler® in delivering budesonide. The objective of this study was to show non-inferiority of inhaled formoterol therapy delivered through the Novolizer® compared to formoterol delivered through the Aerolizer® in patients suffering from moderate to severe asthma.MethodsIn this double-blind, double-dummy, multicentre study 392 patients were randomised and received a dose of 12 μg formoterol twice daily for 4 weeks either through the Aerolizer® or the Novolizer®. FEV1 after 4 weeks of treatment was the primary variable. Secondary variables were FVC, PEF, consumption of short-acting 2 adrenoceptor agonists, asthma symptoms, tolerability and safety.ResultsAfter 4 weeks of treatment, the mean trough FEV1 (95% CI) was 2.34 L (2.24–2.45) for the Novolizer® and 2.31 L (2.21–2.41) for the Aerolizer®. Non-inferiority was proven (p<0.0001, pre-defined  of 0.25 L). All secondary variables (incl. PEF) confirmed these findings. Treatment with both devices was safe and well tolerated.ConclusionInhalation of 12 μg formoterol twice daily via Novolizer® was shown to be equally therapeutically effective compared to the inhalation via Aerolizer® in the treatment of moderate to severe persistent asthma. Treatment via both inhalers was safe and well tolerated.