Abstract
We assessed the long-term efficacy and safety of salmeterol /fluticasone propionate (FP) combination (SFC) delivered by a chlorofluorocarbon-free pressurised metered-dose inhaler (pMDI) in 40 asthmatic children aged 5 to 14 years in Japan. All subjects were taking inhaled corticosteroids (FP 100-200μg/day or equivalent) before the study and 37 subjects had moderate persistent asthma and 3 had severe persistent asthma. The mean age was 8.7 years. Each subject took SFC pMDI 25/50μg, two inhalations twice daily, for 24 weeks. The majority (85.0%) used the Aerochamber Plus® spacer. All the subjects completed the 24-weeks study treatment period.
There were improvements in morning PEF beginning on the first day of treatment and continuing through the study treatment. Mean change in morning PEF over 24 weeks of treatment was 32.9L/min. Mild tremor noted in one subject was the only adverse event assessed by the investigating physician as ''drug-related''. There were no significant changes in plasma cortisol concentrations.
The study demonstrated the long-term efficacy and tolerability of SFC pMDI 25/50μg, two inhalations twice daily, in children with moderate persistent or severe persistent asthma.
