To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Levalbuterol Pediatric Trial Confirms Safety and Efficacy Advantages URL: http://www.pslgroup.com/dg/2170E.htm Doctor's Guide March 20, 1997
MARLBOROUGH, Mass. -- March 20, 1997 -- The results of a dose-finding trial of levalbuterol in children with asthma show the drug offers better results over racemic albuterol. The study was a 43- patient, double-blind, placebo-controlled, crossover trial designed to define the optimal dose for pediatric patients aged six to eleven. The study compared four doses of levalbuterol, two doses of racemic albuterol, and placebo delivered as inhalation solution by nebulizer. Patients received single doses on four separate occasions. Lung function was measured at periodic intervals for eight hours after dosing. Safety measurements, including pulse rates and glucose and potassium levels, also were monitored. Levalbuterol, at the highest dose tested, offered superior lung function over all doses of racemic albuterol tested, as measured by FEV1. Also, at doses offering equivalent efficacy to the standard racemic dose, levalbuterol demonstrated an approximate 50% reduction in beta-mediated side-effects. This pediatric bronchodilation study confirmed Sepracor's recently-announced pivotal Phase III results, which indicated, in a 362-patient trial, improved lung function with longer duration of action of levalbuterol compared with racemic albuterol. In addition, the dose of levalbuterol that provided equivalent lung function to the marketed racemic product showed decreases in beta-mediated side effects, which include pulse rate increase, tremor, nervousness, and changes in potassium and glucose blood levels. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.