A. Vonberg et al., A COMPARISON OF REGULAR SALMETEROL VS AS REQUIRED SALBUTAMOL THERAPY IN ASTHMATIC-CHILDREN, Respiratory medicine, 92(2), 1998, pp. 292-299
In a multicentre, double-blind, randomized, parallel study, 426 asthma
tic children aged 5-15 years old received salmeterol 50 mu g b.i.d, or
placebo b.i.d, via the Diskhaler(TM). All patients had access to inha
led salbutamol to be used on an 'as required' (p.r.n.) basis for sympt
omatic relief. The study design comprised a 2-week baseline, a 12-mont
h treatment period incorporating 2-week 'off treatment' after 6 months
, and a 2-week follow-up period at the end of the trial. At the end of
12 months of treatment with salmeterol, the adjusted change from base
line for morning and evening peak expiratory flow rate (PER was 56 and
471 min(-1), respectively, and this was significantly greater than pl
acebo (P<0.01; P<0.05). Exacerbation rates did not differ between grou
ps and results were not dependent upon concurrent inhaled steroid use,
Neither treatment caused a change of 21 doubling dose in PC20/PD20 ei
ther during or on stopping treatment. Treatment with regular salmetero
l 50 mu g b.i.d. over a 12-month treatment period provides a significa
nt, rapid and will-maintained improvement in lung function without inc
reasing bronchial reactivity or asthma exacerbation rates compared to
p.r.n. salbutamol.