Abstract
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.
Highlights
Metered dose inhalers (MDIs) were introduced >50 years ago, they still remain the most popular and widely used inhalation devices in the treatment of lung disease, with ~340 million units used worldwide each year [1,2]
Formoterol delivered via CFC metered dose inhalers (MDIs) is a safe and effective, long-acting beta2-agonist indicated for the treatment of asthma
It has a duration of action of >12 hours and protects against bronchoconstriction induced by challenge with histamine, methacholine, and exercise [5,6]
Summary
Metered dose inhalers (MDIs) were introduced >50 years ago, they still remain the most popular and widely used inhalation devices in the treatment of lung disease, with ~340 million units used worldwide each year [1,2]. Chlorofluorocarbons (CFCs) have been used as medicinal aerosol propellants and solvents in MDIs owing to their nontoxic, inert and non-flammable properties. Formoterol delivered via CFC MDI is a safe and effective, long-acting beta2-agonist indicated for the treatment of asthma. It has a duration of action of >12 hours and protects against bronchoconstriction induced by challenge with histamine, methacholine, and exercise [5,6]. Any reformulation of the CFC MDI for formoterol would have to have equivalent therapeutic properties
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