Duration of action of the salmeterol/fluticasone combination inhaler administered in the evening: A randomized controlled trial in childhood asthma

Objective and background: To investigate the duration of bronchodilator action of a salmeterol/ fluticasone combination (SFC) inhaler when administered in the evening to children with asthma. Methodology: Design: A double-blind, placebo-controlled, cross-over study. Setting: Hospital inpatient. Subjects: Fourteen children aged between 4 and 11 years with mild to moderate asthma (FEV1 > 60% predicted) who exhibited a 15% increase in FEV1 with bronchodilator. Interventions: Subjects inhaled, in random order, either SFC (100/50 mu g) or placebo, via accuhaler, at 20.00 hours on two separate occasions with at least 3 days between study days. Outcome measures: Lung function measurements including FEV1, PEF, specific airways conductance (sGaw) and maximum expiratory flow at 25-75% of vital capacity were measured at baseline, 2, 12, 16, 20 and 24 h. Results: For all lung function parameters SFC resulted insignificantly greater bronchodilation than placebo for at least 20 h after inhalation. At 24 h, the increase in FEV1 and PEF compared with placebo was 0.08 L (95% confidence interval: -0.18 to 0.02, P= 0.16) and 27 L/min (95% confidence interval: -47 to -6, P= 0.004), respectively. Conclusions: The single administration of SFC via an accuhaler in the evening resulted in significant bronchodilation for at least 20 h in children with asthma.