PURPOSE: Beta agonists are the standard for treating acute airway obstruction in infants. Limited efficacy and safety data exist in this population, which given the age of this population may be attributed to lack of objective measures and rapidly fluctuating clinical examination findings.
METHODS: Acutely wheezing children in an urgent care setting were studied in a randomized, double-blind, parallel group, multicenter study (SB030002). Albuterol HFA 180mcg (n=43) or 360mcg (n=44) was administered via MDI Aerochamber Plus® and facemask every twenty minutes for the first hour, and hourly for the next two hours for a total of 6 doses. Efficacy was evaluated using Modified Tal Asthma Symptom Score (MTASS range 0-12, lower scores indicating less respiratory distress) composite of respiratory rate, wheezing, cyanosis and accessory muscle utilization; and additional albuterol use. Adverse Events (AEs), signs and symptoms of adrenergic stimulation, ECGs, glucose, and potassium were assessed.
RESULTS: The mean baseline MTASS was similar between groups (5.7 and 5.8). The mean change from baseline MTASS over the entire treatment period was -2.7 (-49.8%) and -2.6 (-48.4%) for the 180mcg and 360mcg groups respectively. Four (9%) and 3 (7%) subjects used additional rescue albuterol in the 180 and 360mcg groups respectively. Most subjects required an average of four doses to achieve a status requiring no further treatment; 27 (63%) and 20 (45%) subjects in the 180 mcg and 360mcg groups respectively. The overall incidence of AEs during treatment was low (9% and 7%). One subject each experienced drug related ventricular extrasystoles (180mcg) and tachycardia (360mcg). No cases of drug-related QT/QTc prolongation or hypokalemia were observed with no differences between treatment groups in glucose values. Adrenergic stimulation (increased heart rate, ECG and AEs) was similar between the two treatments.
CONCLUSION: Repeat albuterol dosing demonstrated a reduction (44-50%) in MTASS with no significant safety differences between the two treatment groups.
CLINICAL IMPLICATIONS: This study provides practicing physicians with additional safety and efficacy data for repeat albuterol dosing to treat symptoms of acute bronchospasm in this population.
DISCLOSURE: Julie Shepard, Employee C. Crim MD, R. Trivedi MS, W. Lincourt BS, A. Ellsworth BS, A. Davis MD, are all employees of GlaxoSmithKline; Other J Shepard MD., was one of the Principal Investigator's for the study; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. Ventolin is approved for ages 4 years and older; this abstract discusses data in a population <2 years