Safety of daily albuterol in infants with a history of bronchospasm: a multi-center placebo controlled trial.
BACKGROUND
Inhaled short-acting bronchodilators are recommended for the quick relief of bronchospasm symptoms in children including those less than five years of age. However, limited safety data is available in this young population.


METHODS
Safety data were analyzed from a randomized, double-blind, parallel group, placebo-controlled multicenter, study evaluating albuterol HFA 90microg or 180microg versus placebo three times a day for 4 weeks using a valved holding chamber, Aerochamber Plus and facemask in children birth </=24 months old with a history of bronchospasm.


RESULTS
THE OVERALL INCIDENCE OF ADVERSE EVENTS (AE) DURING TREATMENT WAS: albuterol 90microg (59%), albuterol 180microg (76%) and placebo (71%). The most frequently reported AEs were pyrexia in 7 (24%), 2 (7%), and 3 (11%) subjects in the albuterol 180microg, albuterol 90microg, and placebo groups, respectively. Upper respiratory tract infection (URTI) occurred in 5 (17%) and 3 (11%) subjects in the albuterol 180microg and placebo groups, respectively. Sinus tachycardia occurred in 5 (17%), 2 (7%) and 2 (7%) subjects receiving albuterol 180microg, albuterol 90microg and placebo, respectively. One subject in each of the albuterol treatment groups experienced drug related agitation and/or restlessness or mild sinus arrhythmia. No drug-related QT prolongation or abnormal serum potassium and glucose levels were reported in the albuterol treatment groups.


CONCLUSIONS
This study provides additional albuterol HFA safety information for the treatment of children aged birth </=24 months with a history of bronchospasm.
Hedrick
James A
JA
Kentucky Pediatric/Adult Research, 201 South 5 Street, Suite 102; Bardstown, Kentucky 40004, USA.
Baker
James W
JW
Atlas
Arthur B
AB
Naz
Aftab A
AA
Lincourt
William R
WR
Trivedi
Roopa
R
Ellworth
Anna
A
Davis
Angela M
AM