Therapeutic equivalence of a novel budesonide/formoterol pMDI versus budesonide/formoterol turbuhaler® in adolescents and adults with asthma

Abstract

RATIONALE: Budesonide/formoterol (Symbicort®) is effective treatment for asthma and COPD. This study compared the efficacy and safety of a novel pMDI formulation of budesonide/formoterol versus budesonide/formoterol Turbuhaler® (160/4.5 μg [delivered dose] 2 inhalations bid, both formulations) and budesonide (Pulmicort®) pMDI (200 μg metered dose [corresponds to 160 μg delivered dose] 2 inhalations bid). METHODS: This was a multinational, 12-week, randomized, double-blind, double-dummy, parallel-group study involving patients with asthma (age ≥12 years; FEV1 50-90% predicted; inadequately controlled on inhaled corticosteroids [500-1600 μg/day]). The primary efficacy endpoint was change from baseline in morning PEF (mPEF). Secondary endpoints included change in evening PEF, FEV1, night-time awakenings, total asthma symptom score, rescue medication use, and Asthma Quality of Life Questionnaire overall score. Safety assessments included adverse events and laboratory parameters. RESULTS: In total, 680 patients were randomized to treatment, of whom 668 were included in the primary efficacy analysis. Therapeutically equivalent increases in mPEF were observed with budesonide/formoterol pMDI (29.3 L/min) and Turbuhaler (32.0 L/min) (95% CI: -10.4, 4.9; p=0.48). No significant differences in secondary endpoints were observed between these two groups. The increase in mPEF with budesonide/formoterol pMDI was significantly higher than with budesonide pMDI (+28.7 L/min; p<0.001). Similar improvements with budesonide/formoterol pMDI versus budesonide pMDI were seen for secondary endpoints. There were no clinically important differences between treatment groups with regard to adverse events and laboratory parameters. CONCLUSIONS: Budesonide/formoterol in one pMDI is therapeutically equivalent to budesonide/formoterol Turbuhaler.