Abstract
We assessed the efficacy, safety and convenience of salmeterol (SLM)/fluticasone propionate (FP) combination (SFC) in children with asthma. The study was a 4-week crossover design in which each subject received the two treatments, SFC 25/50μg (one inhalation twice daily by pMDI with counter) and SLM 25μg plus FP 50μg (each one inhalation twice daily by DPI) separated by a 2-week washout period. This was followed by an extension phase in which all subjects who completed the crossover treatment received SFC 25/50μg (one inhalation twice daily by pMDI with counter) for 20 weeks. A total of 51 patients were enrolled in the study. The crossover phase efficacy population consisted of 48 patients (32 males and 16 females; mean age, 8.4 years; range, 5 to 14) with mild persistent asthma (11 patients) or moderate persistent asthma (37 patients). The majority (89.6%) used the Aerochamber Plus® spacer for inhalations of SFC. In the crossover phase, both treatments showed statistically significant improvements from baseline [SFC: 14.6L/min (p=0.0030) , SLM+FP: 17.0L/min (p=0.0003)] in morning PEF and the difference between the treatment groups was not statistically different. In the assessment of convenience, SFC was rated higher compared with SLM+FP. The SFC pMDI with counter was assessed useful to confirm their inhalations of the drug. Fifty patients entered and completed the extension phase. Improved PEF observed at the end of crossover phase was sustained through the extension phase. SFC was safe and well tolerated through the study. [Trial registration: Clinicaltrials. gov Identifier: NCT00448435]
