Comparison of salmeterol/fluticasone propionate (FP) combination with FP+sustained release theophylline in moderate asthma patients

SummaryObjectivesTo compare the efficacy and safety of the salmeterol/fluticasone propionate combination product with concurrent sustained release theophylline plus fluticasone propionate in adult Japanese patients with persistent asthma.DesignMulticentre, randomised, double-blind, double-dummy, parallel-group study.Patients and interventionsThree hundred and eighty-three asthmatic patients receiving sustained release theophylline 200–400 mg/day entered the study and were randomised to receive either salmeterol/fluticasone propionate combination (SFC) 50 μg/250 μg+1 placebo tablet, fluticasone propionate 250 μg+1 sustained release theophylline 200 mg (SR-T+FP), twice daily for 8 weeks.ResultsThe adjusted mean change morning peak expiratory flow (PEF) over 8 weeks was 29.8 L/min in the SFC group and 16.3 L/min in the SR-T+FP group, with a treatment difference of 13.4 L/min (p=0.0004). SFC improved evening PEF, FEV1, V˙50 and V˙25 at the completion of treatment to a greater extent than SR-T+FP (all p<0.05). A higher percentage of patients on SFC were symptom free (p=0.0286) and rescue free (ns) than those on SR-T+FP. There was not a statistically significant difference between treatments in symptom scores. Both treatments were well tolerated.ConclusionsThe finding that SFC was associated with greater improvements in lung function than SR-T+FP, a commonly employed treatment for asthmatic patients in Japan, suggests that SFC should be the preferred therapeutic option in these patients.