Repeat dosing of albuterol via metered-dose inhaler in infants with acute obstructive airway disease: a randomized controlled safety trial.
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.


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%.
Kaashmiri
Mohammed
M
Children's Health Center, St Elizabeth Medical Center, Utica, NY 13502, USA. kaashmiri@adelphia.net
Shepard
Julie
J
Goodman
Brad
B
Lincourt
William R
WR
Trivedi
Roopa
R
Ellsworth
Anna
A
Davis
Angela M
AM
D000280:Administration, Inhalation; D000336:Aerosols / Q000008:administration & dosage* / Q000494:pharmacology; D000420:Albuterol / Q000008:administration & dosage* / Q000494:pharmacology; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000494:pharmacology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D006845:Hydrocarbons, Fluorinated; D007223:Infant; D007231:Infant, Newborn; D008173:Lung Diseases, Obstructive / Q000188:drug therapy*; D008297:Male; D008397:Masks; D036501:Metered Dose Inhalers / Q000706:statistics & numerical data; D012135:Respiratory Sounds / Q000187:drug effects; D013997:Time Factors; D016896:Treatment Outcome; D005466:Fluorocarbons
D000336:Aerosols; D000420:Albuterol; D001993:Bronchodilator Agents; D006845:Hydrocarbons, Fluorinated; C094049:apaflurane; D005466:Fluorocarbons