Background DuoResp Spiromax® (Teva Pharmaceuticals) is a dry-powder inhaler designed to deliver budesonide and formoterol fumarate (BF Spiromax®) with maximum ease of use. Pharmacokinetic studies have shown bioequivalence of BF Turbuhaler®. This study compared the efficacy and safety of these devices in patients with asthma.
Methods This was a 12-week, multicentre, double-blind, randomised, controlled trial (N=605). Eligible patients (≥12 years old) had persistent asthma with FEV1 40–85% predicted, had used a SABA and ICS for ≥8 weeks before screening and were maintained on stable-dose ICS for 4 weeks. The primary objective was to demonstrate non-inferiority of twice-daily BF Spiromax® 160/4.5mcg to BF Turbuhaler® 200/6mcg, with respect to change from baseline in weekly average of daily trough morning PEF.
Results This analysis was based on the per protocol population (N=290 and N=284 for BF Spiromax® and BF Turbuhaler® groups, respectively). The least squares mean change from baseline to Week 12 in morning PEF was 18.8 L/min with BF Spiromax® and 21.796 L/min with BF Turbuhaler®. Non-inferiority of BF Spiromax® vs BF Turbuhaler® was demonstrated, as the lower limit of the 95% two-sided CI (–9.02 L/min) is greater than –15 L/min. Similarly, no significant between-group differences were observed in secondary efficacy endpoints. Both devices were well tolerated, with no significant differences in the incidence of adverse events or asthma exacerbations.
Conclusions This study has demonstrated the non-inferiority of BF Spiromax® vs BF Turbuhaler® in adults and adolescents with asthma. Further data are required to confirm whether BF Spiromax® can be used as an alternative to BF Turbuhaler® in other indications.
Sponsor: Teva Pharmaceuticals.
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