Prevention of exercise-induced bronchospasm in pediatric asthma patients: A comparison of two salmeterol powder delivery devices

Background. A powder formulation of salmeterol has been shown to prevent ex ercise-induced bronchospasm (EIB) in asthmatic children and adults; however , the delivery device (Diskhaler; Glaxo Wellcome Inc, Research Triangle Par k, NC) must be reloaded after 4 doses. A new multidose powder inhaler (Disk us) provides 60 doses of salmeterol in a blister pack presentation with a d ose counter. Objective. To evaluate the safety and efficacy of 50-mu g salmeterol powder via two different delivery systems (Diskhaler and Diskus) in preventing EI B in asthmatic children. Study Design. A randomized, double-blind, double-dummy, single-dose, placeb o-controlled, three-way crossover study was conducted in 24 children 4 to 1 1 years of age demonstrating EIB and mild to moderate asthma. Serial forced expiratory volume in 1 second (FEV1) was measured before and after treadmi ll exercise challenges conducted at 1, 6, and 12 hours after study drug adm inistration. Adverse events were also assessed. Results. During all exercise challenges, EIB-mediated reductions in FEV1 we re minimized or prevented in patients receiving single doses of salmeterol powder compared with placebo. Single doses of salmeterol powder delivered v ia either system were equally effective in preventing EIB. There were no dr ug-related adverse events, cardiovascular, or other clinically relevant saf ety concerns. Conclusions. Single doses of salmeterol powder delivered by either delivery system are safe and effective in preventing EIB for greater than or equal to 12 hours in asthmatic children.