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

Abstract

RATIONALE: Budesonide/formoterol in one inhaler (Symbicort®) is an established therapy for asthma and COPD. The long-term safety of a novel pMDI formulation of budesonide/formoterol was compared with that of budesonide/formoterol Turbuhaler® (160/4.5 μg 2 inhalations bid, both formulations). METHODS: This was a multinational, 52-week, randomized, open, parallel-group study. Inclusion criteria included: asthma (ATS criteria); age ≥12 years; FEV1 ≥50% predicted; and use of inhaled corticosteroid (400-1200 μg/day) with need for additional inhaled short-acting β2-agonist therapy. Safety endpoints included assessment of adverse events (AEs), laboratory parameters, and morning plasma cortisol. Secondary efficacy endpoints included change from baseline in FEV1 and FVC, and time to first severe asthma exacerbation. RESULTS: Overall, 673 patients (446 pMDI, 227 Turbuhaler) were included in safety evaluations. There were no clinically significant differences between treatment groups with regard to the nature, incidence, or severity of AEs, laboratory parameters, or plasma cortisol. The number of patients experiencing AEs was comparable in the pMDI (332/446 [74%]) and the Turbuhaler (175/227 [77%]) groups. The most commonly reported AE was upper respiratory tract infection. A similarly small proportion of patients in the pMDI group (12/446 [3%]) discontinued the study owing to AEs compared with the Turbuhaler group (2/227 [1%]). No differences were detected between budesonide/formoterol pMDI and Turbuhaler for any efficacy parameter. CONCLUSIONS: The novel pMDI formulation of budesonide/formoterol has an equivalent long-term safety profile to budesonide/formoterol Turbuhaler.