F. Ceugniet et al., PROPHYLACTIC TREATMENT OF EXERCISE-INDUCE D ASTHMA IN CHILDREN - SALMETEROL OR SODIUM CROMOGLYCATE SINGLE-DOSE BEFORE EXERCISE, Annales de pediatrie, 44(9), 1997, pp. 625-634
Methods: Thirty-two children between 10 and 17 were included in a rand
omised, double-blind and cross-over, single centre study, aiming to co
mpare the efficacy and safety of a single 50 mu g salmeterol (S) dose,
with those of a single 40 mg sodium cromoglycate (CG) dose in exercis
e-induced asthma. The children had shown at a first selection visit a
bronchoconstriction after exercice corresponding to a 15% or more fall
in FEV1. The study consisted of two treatment periods, during which t
hree exercise tests were performed, 1 hour, 4 hours, and 10 hours afte
r study treatment administration. Results: The intent-to-treat analysi
s was performed on the 24 evaluable children who had received both tre
atments. S proved to be superior to CG for the primary assessment crit
eria which was the mean percentage fall in FEV 1 after exercise at the
tenth hour (17% in the S group versus 35% in the CG group, p = 0,0001
). The protection offered by salmeterol was found to be higher for all
the other assessment criteria at all the assessment times: the percen
tages elf patients with a fall in FEV1 of 15% or more at the tenth hou
r were respectively 42% versus 71% (p = 0,01). The mean fall in FEV1 a
fter exercise was 9% versus 25% at the first hour, 5% versus 25% at th
e fourth hour. A 15% or more fall in FEV1 at the first hour was seen f
or 13% versus 71% of patients, 13% versus 67% at the fourth hour. The
assessment of dyspnea by the patient supported these results. All the
adverse events reported during the treatment period were asthma crisis
, considered by the investigator as not related to the study treatment
. Their frequency was higher with CG (p = 0,02). Conclusion: This stud
y demonstrated the higher efficacy of salmeterol compared to sodium cr
omoglycate in protection against exercise-induced asthma in children.
This maintained protection at least ten hours after treatment makes sa
lmeterol a therapeutic improvement in management of exercise-induced a
sthma in children.