PROPHYLACTIC TREATMENT OF EXERCISE-INDUCE D ASTHMA IN CHILDREN - SALMETEROL OR SODIUM CROMOGLYCATE SINGLE-DOSE BEFORE EXERCISE

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.