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

Autor: Kyousuke Ishihara, Hisamichi Aizawa, Mitsuyoshi Nakashima, Hiroyuki Taniguchi, Yasuyuki Sano, Ken Ohta, Mitsuru Adachi
Rok vydání: 2008
Předmět:
Zdroj: Respiratory Medicine. 102(7):1055-1064
ISSN: 0954-6111
DOI: 10.1016/j.rmed.2008.01.021
Popis: Summary 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) 50μg/250μg+1 placebo tablet, fluticasone propionate 250μg+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, FEV 1 , V ˙ 50 and V ˙ 25 at the completion of treatment to a greater extent than SR-T+FP (all p 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.
Databáze: OpenAIRE