Extrafine beclomethasone/formoterol combination via a dry powder inhaler (NEXThaler®) or pMDI and beclomethasone monotherapy for maintenance of asthma control in adult patients: A randomised, double-blind trial

Background: The fixed combination of extrafine beclomethasone dipropionate and formoterol fumarate (BDP/FF) pMDI (Foster (R)) is approved for treatment of adult asthmatic patients. In order to provide an alternative drug delivery system for BDP/FF to physicians and patients, a dry powder inhaler (NEXThaler (R)) has been developed, capable to deliver extrafine particles to the lungs and therefore improve the dosing of the drugs, especially in patients with poor hand-breath coordination. Objective: This trial was performed to compare efficacy and safety of extrafine BDP/FF NEXThaler (R) with extrafine BDP/FF pMDI or non-extrafine BDP DPI alone in adult patients with controlled asthma. Methods: In this 8-week randomised, double-blind, parallel-group trial, patients were randomized to receive either extrafine BDP/FF NEXThaler (R) 100/6 mu g bid, extrafine BDP/FF 100/6 mu g pMDI bid or non-extrafine BDP DPI 100 mu g bid. The primary efficacy variable was change from baseline to the entire 8-week randomised treatment period in average pre-dose morning PEF. Results: The ITT population comprised 754 patients. Extrafine BDP/FF NEXThaler (R) was non-inferior (predefined margin: -15 L/min) relative to extrafine BDP/FF pMDI (mean difference: -1.84; 95% CI: -6.73, 3.05) in terms of the primary efficacy variable, change from baseline in average pre-dose morning PEE Statistical superiority of both extrafine BDP/FF formulations over non-extrafine BDP DPI was demon. strated for the primary efficacy variable (providing evidence of assays sensitivity of the trial), ACQ score and percentage of rescue medication use-free days. No significant safety signals were observed. Conclusion: NEXThaler (R) is an effective and well-tolerated delivery device for treatment of patients with asthma who need a regular treatment. (C) 2014 The Authors. Published by Elsevier Ltd.