Safety of Daily Albuterol in Infants with a History of Bronchospasm: A Multi-Center Placebo Controlled Trial§



James A Hedrick1, James W Baker2, Arthur B Atlas3, Aftab A Naz4, William R Lincourt*, 5, Roopa Trivedi5, Anna Ellworth5, Angela M Davis5
1 Kentucky Pediatric/Adult Research, 201 South 5th Street, Suite 102; Bardstown, Kentucky 40004, USA
2 Allergy, Asthma and Dermatology Research Center, LLC, 3975 SW Mercantile Drive, Suite 165; Lake Oswego, Oregon 97035, USA
3 Morristown Memorial Hospital, 100 Madison Avenue, Morristown, New Jersey 07960, USA
4 Madera Family Medical Group, 1111 West 4th Street, Madera, California 93637, USA
5 GlaxoSmithKline, 5 Moore Drive, Research Triangle Park, North Carolina 27709, USA


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© Hedrick et al.; Licensee Bentham Open.

open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.

* Address correspondence to this author at the GlaxoSmithKline, 5 Moore Drive, Research Triangle Park, NC 27709, USA; Tel: (919) 483-6284 ; Fax: (919) 483-4300; E-mail: william.r.lincourt@gsk.com


Abstract

Introduction:

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 90µg or 180µg 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 90µg (59%), albuterol 180µg (76%) and placebo (71%). The most frequently reported AEs were pyrexia in 7 (24%), 2 (7%), and 3 (11%) subjects in the albuterol 180µg, albuterol 90µg, and placebo groups, respectively. Upper respiratory tract infection (URTI) occurred in 5 (17%) and 3 (11%) subjects in the albuterol 180µg and placebo groups, respectively. Sinus tachycardia occurred in 5 (17%), 2 (7%) and 2 (7%) subjects receiving albuterol 180µg, albuterol 90µg 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.

Conclusion:

This study provides additional albuterol HFA safety information for the treatment of children aged birth ≤24 months with a history of bronchospasm.