Viapaed Study In Children And Adolescents With Asthma
Status:
Completed
Trial end date:
2007-04-12
Target enrollment:
Participant gender:
Summary
Asthmatic children who remain symptomatic on inhaled corticosteroids (ICS) require an
adjustment of their asthma therapy. Current guidelines suggest that the treatment options are
either an increased dose of inhaled corticosteroid or the addition of other therapy such as a
long-acting beta-agonist (LABA). In the pediatric age range, major concerns with respect to
high dose ICS therapy are growth retardation and the suppression of the
hypothalamic-pituitary-adrenocortical (HPA) axis. Previous studies in adults have shown that
a combination product that included a LABA as well as the ICS allowed to reduce the steroid
dose and was still at least as effective in achieving asthma control as treatment with a
higher dose of ICS. These treatment options shall be compared in the present study. Children
who remain symptomatic while inhaling 100 µg fluticasone (FP) twice daily shall be randomized
to receive the salmeterol/ fluticasone combination product, Viani (SERETIDE) 50/100 µg, or
fluticasone 200 µg as a comparator drug, inhaled twice daily via the DISKUS for a period of
eight weeks.