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

OBJECTIVES: To 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.

DESIGN: Multicentre, randomised, double-blind, double-dummy, parallel-group study.

PATIENTS AND INTERVENTIONS: Three hundred and eighty-three asthmatic patients receiving sustained release theophylline 200-400mg/day entered the study and were randomised to receive either salmeterol/fluticasone propionate combination (SFC) 50microg/250microg+1 placebo tablet, fluticasone propionate 250microg+1 sustained release theophylline 200mg (SR-T+FP), twice daily for 8 weeks.

RESULTS: The adjusted mean change morning peak expiratory flow (PEF) over 8 weeks was 29.8L/min in the SFC group and 16.3L/min in the SR-T+FP group, with a treatment difference of 13.4L/min (p=0.0004). SFC improved evening PEF, FEV1, V50 and V25 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.

CONCLUSIONS: The 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.