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a Department
of Paediatrics, Imperial School of Medicine at the National Heart and
Lung Institute, London, UK, b Department of Thoracic Medicine, c GlaxoWellcome UK Ltd
Correspondence to: Dr A Bush, Department of Paediatric Respiratory Medicine, Royal Brompton Hospital, Sydney Street, London SW3 6NP, UK email: a.bush{at}rbh.nthames.nhs.uk
Received 17 August 1999; Returned to authors 4 November 1999; Revised version received 5 June 2000; Accepted for publication 14 June 2000
BACKGROUND
The
addition of long acting inhaled
2 agonists is
recommended at step 3 of the British guidelines on asthma management
but a recent study suggested no additional benefit in children with asthma.
METHODS
The aim of
this study was to compare, in a double blind, three way, crossover
study, the effects of the addition of salmeterol 50 µg bd,
salmeterol 100 µg bd, and salbutamol 200 µg qds in asthmatic children who were symptomatic despite treatment with inhaled
corticosteroids in a dose of at least 400 µg/day over a one month
period. Symptom scores, morning and evening peak expiratory flow (PEF)
rates, use of rescue medication, spirometric indices, and histamine
challenge were measured.
RESULTS
Forty five
children aged 5-14 years were enrolled. All three treatments improved
asthma control, morning and evening PEF rates, and spirometric indices
with no change in bronchial hyperreactivity. Mean morning PEF was
significantly better during the salmeterol treatment periods than with
salbutamol treatment (p<0.05). The analysis of mean morning PEF gave
an estimated treatment difference of 9.6 l/min for salmeterol 50 µg
bd versus salbutamol 200 µg qds (95% confidence interval (CI) 2.1 to 17.1), and an estimated treatment difference of 13.8 l/min for
salmeterol 100 µg bd versus salbutamol 200 µg qds (95% CI 6.0 to
21.5). There were no significant differences between the two doses of
salmeterol and all treatments were well tolerated.
CONCLUSIONS
In this
population of moderate to severe asthmatic children on inhaled
corticosteroids, salmeterol in a dose of either 50 µg bd or
100 µg bd is significantly more effective at increasing the morning
PEF rate over a one month period than salbutamol 200 µg qds. The
data provided no significant evidence of a difference in efficacy
between the two doses of salmeterol, 50 µg and 100 µg. A trial of
salmeterol 100 µg bd may be worth considering in those still
symptomatic on the lower dose.
agonists
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