Medicina Pulmonar e Respiratória

Assessment of Efficacy and Safety between Two Formulations of Formoterol Fumarate in Adolescents and Adults with Persistent Asthma

Abstract

Mahesh P, Joshi J, Rebello J, Purandare SM and Gogtay JA

Objective: The mandatory replacement of chlorofluorocarbons (CFCs) in pressurized metered dose inhalers (pMDIs) with non ozone depleting propellants such as hydrofluoroalkanes (HFA 134a) requires clinical testing that ensures the reformulated aerosol with HFA is as effective and well tolerated as the original CFC version. In view of this, a multicentre, randomised, parallel-group, double-blind study was conducted to compare the safety and efficacy of formoterol fumarate delivered by a MDI using the hydrofluoroalkane (HFA) 134a propellant (Cipla Ltd) with the CFC formulation (Foradil CFC pMDI, Novartis, UK) in adolescents and adults.

Methods: Patients on a stable dose of inhaled corticosteroids with a scope for improvement based on mean morning peak expiratory flow (PEF) and symptoms were randomised to receive formoterol HFA MDI 24 mg twice daily or formoterol CFC MDI 24 mg twice daily for 12 weeks. The primary efficacy variable was the mean morning PEF and secondary variables included FEV1, symptom scores, use of relief medication and safety assessments.

Results: The difference between the treatments in the adjusted mean morning PEF (formoterol HFA–formoterol CFC) was -4.68 L/min (95% CI: -13.45, 4.09). The lower limit of the 95% confidence interval was within the pre-defined limit (20 L/min) set for non-inferiority. The results of the secondary endpoints supported the findings of the primary endpoint. The incidences of adverse events (AEs) were similar for both formulations.

Conclusion: The results of this study confirm that formoterol HFA pMDI is as effective as formoterol CFC pMDI in adolescents and adults.