A Comparison of Fluticasone Propionate,l00mug Twice Daily, Administered Via a CFC and Non-CFC Propellant, HFA 134a, in Adult Patients with Asthma

摘要

Objective: This study was designed to demonstrate equivalent efficacy and similar tolerability of a fluticasone propionate (FP) 50mug hydrofluoroalkane HFA 134a formulation with that of the established chlorofluorocarbon (CFC) 50mug formulation in adult patients with asthma.Design and Setting: The study was a multicentre, randomised, double-blind, parallel-group design conducted in general practice centres in the UK.Patients: Adult patients with mild asthma who were receiving inhaled pVagonists as required and up to 400mug of inhaled corticosteroid.Interventions: 178 patients were randomised to receive FP l00mug twice daily via a pressurised metered-dose inhaler (pMDI) propelled by HFA 134a and 173 patients to FP administered via a CFC pMDI for 4 weeks.Results: Fluticasone propionate significantly improved lung function in both groups. Mean morning peak expiratory flow (PEF) increased by 17 L/min in the HFA 134a group and 19 L/min in the CFC group, with a mean treatment difference between the two formulations (HFA-CFC) of -2 L/min, with a 90% confidence interval of (-8; +4 L/min), well within the pre-set equivalence limit of ±15 L/min. A comparable increase in evening PEF, symptom-free days and nights, days and nights with no rescue medication and clinic lung function was seen between the groups. The frequency of adverse events was low and equally distributed. Neither treatment had any significant effect on morning serum cortisol levels and there were no reported incidences of bronchospasm.Conclusions: The FP 50mug HFA 134a pMDI is as effective and well tolerated as the CFC product. It is a suitable replacement for the 50mug CFC pMDI product at a microgram equivalent dose.