High-dose albuterol by metered-dose inhaler plus a spacer device versus nebulization in preschool children with recurrent wheezing: A double-blind, randomized equivalence trial

Inhaled albuterol is the most frequently used bronchodilator for acute whee zing, and nebulization is the standard mode of delivery in hospital setting . However, recent guidelines consider spacer devices as an easier to use, a nd cost-saving alternative and recommend the high-dose metered-dose inhaler bronchodilator. Objective. To demonstrate clinical equivalence between a spacer device and a nebulizer for albuterol administration. Design. Randomized, double-blind, parallel group equivalence trial. Setting. Pediatric emergency wards at 2 tertiary teaching hospitals. Patients. Sixty-four 12- to 60-month-old children with acute recurrent whee zing (32 per group). Interventions. Albuterol was administered through the spacer device (50 mu g/kg) or through the nebulizer (150 mu g/kg) and repeated 3 times at 20-min ute intervals. Parents completed a questionnaire. Outcome Measures. Pulmonary index, hospitalization, ease of use, acceptabil ity, and pulse oximetry saturation. Results. The 90% confidence interval of the difference between treatment gr oups for the median absolute changes in pulmonary index values between T0 a nd T60 was [-1; +1] and was included in the equivalence interval [-1.5; +1. 5]. Clinical improvement increased with time. Less than 10% of the children (3 in each group) required hospitalization (2 in each group attributable t o treatment failure). Parents considered administration of albuterol using the spacer device easier (94%) and better accepted by their children (62%). Conclusions. The efficacy of albuterol administered using the spacer device was equivalent to that of the nebulizer. Given its high tolerance, repeate d 50-mu g/kg doses of albuterol administered through the spacer device shou ld be considered in hospital emergency departments as first-line therapy fo r wheezing.