To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Asthmatic Children Get Sounder Sleep With Twice-Daily Dosing of Budesonide and Formoterol: Presented at ACAAI URL: http://www.pslgroup.com/dg/21867A.htm Doctor's Guide December 4, 2007
By Carole Bullock DALLAS, TX -- November 12, 2007 -- Budesonide is safe and well tolerated in asthmatic children and adolescents, improving night-time and daytime symptoms at the 0.135 mg dose, investigators reported here at the American College of Allergy, Asthma and Immunology (ACAAI) 65th annual meeting. "This is an investigational study and opportunity to use this submicron formulation budesonide in an aqueous suspension for nebulisation [Unit Dose Budesonide (UDB), MAP Pharmaceuticals, USA], to control night and daytime symptoms in children," said Stephen Shrewsbury, MD, Chief Medical Officer, MAP Pharmaceuticals Inc, Mountain View, California, United States. "We did see improvements, but we're not sure why the higher dose didn't work as well -- it's a puzzle," Dr. Shrewsbury said in an interview on November 11. "However, we feel confident in the higher dose and plan to continue studying it." The study randomised 208 and treated 204 children and adolescents with stable but symptomatic asthma to UDB 0.25 mg (68), UDB 0.135 mg (67), or placebo (69) for a maximum 28-day run-in period during which cough, wheeze, breathlessness (scale 0-3) and peak flow (PEF, if able) were recorded in an electronic diary. Subjects with a minimum total symptom score (SS) of 4 in the last 5 days of the run-in period were randomised to one of three double-blind treatments, dosed under supervision, and followed up for 6 weeks with clinic spirometry (on days 0, 14, 28 and 42). The study found: · Total night-time SS adjusted mean improvements were 0.5, 1.3 and 0.5 respectively compared with baseline 2.7, 2.4 and 2.4, respectively (P =.002 for UDB 0.135 mg). · Daytime SS showed similar improvements (0.7, 1.5 and 0.7 change from baseline). · Forced expiratory volume in 1 second (FEV1) showed adjusted mean improvements of 6.2%, 6.7% and 2.3% in a subset of patients with <80% predicted at baseline and 12% or greater reversibility, respectively. · UDB was well tolerated, but at least one adverse event was reported by 50.7%, 32.8% and 55.1%, respectively. · Morning serum cortisol levels increased by an adjusted mean of 0.2, 1.1 and 0.5 g/dL, respectively. · Discontinuation rates were 17.4%, 14.3% and 34.8%, respectively · Asthma deterioration leading to discontinuation was 10.1%, 2.9% and 15.9%, respectively. [Presentation title: Efficacy and Safety of a Novel Submicron Particle Formulation of Budesonide for Nebulized Delivery in Asthmatic Children. Abstract 24] --------------------------------------------------------------------------------------------- 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.