D. Ukena et al., COMPARISON OF ADDITION OF THEOPHYLLINE TO INHALED STEROID WITH DOUBLING OF THE DOSE OF INHALED STEROID IN ASTHMA, The European respiratory journal, 10(12), 1997, pp. 2754-2760
The anti-asthmatic effects of theophylline may supplement those of inh
aled steroids in asthma. The aim of the present trial was to study hol
y the addition of theophylline compares to doubling the dose of inhale
d steroid in asthmatics who remain symptomatic on beclomethasone dipro
pionate (BDP) 400 mu g.day(-1). The trial was designed as a randomized
, double-blind, parallel-group study in several European countries, Si
xty nine patients were treated for 6 weeks with theophylline plus BDP
400 mu g.day(-1), compared to 64 patients treated with BDP 800 mu g.da
y(-1). The mean+/-SD serum theophylline concentration was 10.1+/-4.2 m
g.L-1. Lung function measurements were made throughout the study and p
atients kept daily records of peak expiratory flow (PEF), symptoms and
salbutamol usage, Forced expiratory volume in one second and PEF at m
eek 6 mere significantly increased by both treatments (p<0.01). PEF va
riability was reduced by about 30% in both groups, There were signific
ant improvements in asthma symptoms and rescue medication use (p<0.001
), There mere no significant differences between the treatment groups.
The study demonstrated clinical equivalence of theophylline plus becl
omethasone dipropionate 400 mu g.day(-1) and beclomethasone dipropiona
te 800 mu g.day(-1) in patients whose asthma is not controlled on becl
omethasone dipropionate 400 mu g.day(-1). The results support the use
of theophylline as a steroid-sparing agent, The combination of low-dos
e inhaled steroid plus theophylline is a suitable treatment for modera
te asthma.