Repeat dosing of albuterol via metered-dose inhaler in infants with acute
obstructive airway disease: a randomized controlled safety trial.
Author(s): Kaashmiri M, Shepard J, Goodman B, Lincourt WR, Trivedi R, Ellsworth A, Davis AM.
Affiliation(s): Children's Health Center, St Elizabeth Medical Center, Utica, NY 13502, USA.
kaashmiri@adelphia.net
Publication date & source: 2010, Pediatr Emerg Care. , 26(3):197-202
BACKGROUND: Airway obstruction and bronchial hyperactivity often times lead to
emergency department visits in infants. Inhaled short-acting beta2-agonist
bronchodilators have traditionally been dispensed to young children via
nebulizers in the emergency department. Delivery of bronchodilators via
metered-dose inhalers (MDIs) in conjunction with holding chambers (spacers) has
been shown to be effective.
STUDY OBJECTIVE: : Safety and efficacy evaluations of albuterol sulfate
hydrofluoroalkane (HFA) inhalation aerosol in children younger than 2 years with
acute wheezing caused by obstructive airway disease.
METHODS: A randomized, double-blind, parallel group, multicenter study of
albuterol HFA 180 microg (n = 43) or 360 microg (n = 44) via an MDI with a valved
holding chamber and face mask in an urgent-care setting. Assessments included
adverse events, signs of adrenergic stimulation, electrocardiograms, and blood
glucose and potassium levels. Efficacy parameters included additional albuterol
use and Modified Tal Asthma Symptoms Score ([MTASS] reduction in MTASS
representing improvement).
RESULTS: Overall, adverse events occurred in 4 (9%) and 3 (7%) subjects in the
180-microg and 360-microg groups, respectively. Drug-related tachycardia (360
microg) and ventricular extrasystoles (180 microg) were reported in 1 patient
each. Three additional instances of single ventricular ectopy were identified
from Holter monitoring. No hypokalemia or drug-related QT or QTc prolongation was
seen; glucose values and adrenergic stimulation did not significantly differ
between treatment groups. In the 180-microg and 360-microg groups, mean change
from baseline in MTASS during the treatment period was -2.8 (-49.8%) and -2.9
(-48.4%), and rescue albuterol use occurred in 4 (9%) and 3 (7%) subjects,
respectively.
CONCLUSIONS: Cumulative dosing with albuterol HFA 180 microg or 360 microg via
MDI-spacer and face mask in children younger than 2 years did not result in any
significant safety issues and improved MTASS by at least 48%.
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