THE SAFETY AND EFFICACY OF FORMOTEROL (OXIS®) TURBUHALER® PLUS BUDESONIDE (PULMICORT®) TURBUHALER IN MILD TO MODERATE ASTHMA: A COMPARISON WITH BUDESONIDE TURBUHALER ALONE AND CURRENT NON‐CORTICOSTEROID THERAPY IN RUSSIA

Abstract

SUMMARYCurrent therapy in Russia for long‐term management of asthma is mainly non‐steroidal. This provided the opportunity to compare the efficacy and safety of formoterol (Oxis®) Turbuhaler® plus budesonide (Pulmicort®) Turbuhaler with budesonide Turbuhaler alone in adults (n=338) with mild to moderate asthma who had little previous exposure to inhaled corticosteroids. The 12‐week study followed a randomised, double‐blind, parallel group design and included an open control group of patients who were treated with conventional non‐corticosteroid therapy. Patients treated with formoterol plus budesonide benefited from a significantly greater improvement in their pulmonary function and asthma symptoms compared with budesonide alone (95% CI of difference in mean morning peak expiratory flow [PEF] 8.7–36.3 l/min, p=0.0015). Non‐corticosteroid treatment was significantly less effective than formoterol plus budesonide and budesonide alone (95% CIs of differences in mean morning PEF were 36.4–63.6 l/min and 14.1–41.1 l/min, respectively, both p=0.0001). Although the incidence and frequency of adverse events was not significantly different between the groups, formoterol plus budesonide and budesonide alone were better tolerated than non‐corticosteroid treatment, and there were fewer incidences of asthma deterioration. Overall, formoterol Turbuhaler plus budesonide Turbuhaler was the safest and most effective treatment.