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


METHODS
Multicentre, randomised, double-blind, double-dummy, parallel-group study.


METHODS
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.
Adachi
Mitsuru
M
First Department of Internal Medicine, School of Medicine, Showa University, Tokyo, Japan. adachim@med.showa-u.ac.jp
Aizawa
Hisamichi
H
Ishihara
Kyousuke
K
Ohta
Ken
K
Sano
Yasuyuki
Y
Taniguchi
Hiroyuki
H
Nakashima
Mitsuyoshi
M
D000280:Administration, Inhalation; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000730:Androstadienes / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy* / Q000453:epidemiology; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D000068298:Fluticasone; D005541:Forced Expiratory Volume; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D000068299:Salmeterol Xinafoate; D013806:Theophylline / Q000008:administration & dosage*; D016896:Treatment Outcome
D000730:Androstadienes; D001993:Bronchodilator Agents; D000068299:Salmeterol Xinafoate; D013806:Theophylline; D000068298:Fluticasone; D000420:Albuterol