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Author Bisgaard, H.; Le Roux, P.; Bjamer, D.; Dymek, A.; Vermeulen, J.H.; Hultquist, C. url  doi
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  Title Budesonide/formoterol maintenance plus reliever therapy: a new strategy in pediatric asthma Type Journal Article
  Year (down) 2006 Publication Chest Abbreviated Journal Chest  
  Volume 130 Issue 6 Pages 1733-1743  
  Keywords Adrenal Cortex Hormones/*administration & dosage/adverse effects; Adrenergic beta-Agonists/*administration & dosage/adverse effects; Anti-Asthmatic Agents/*administration & dosage/adverse effects; Asthma/*drug therapy; Budesonide/*administration & dosage/adverse effects; Budesonide, Formoterol Fumarate Drug Combination; Child; Child, Preschool; Delayed-Action Preparations; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Ethanolamines/*administration & dosage/adverse effects; Female; Forced Expiratory Volume/drug effects; Formoterol Fumarate; Glucocorticoids/*administration & dosage/adverse effects; Humans; Male; Prospective Studies; Terbutaline/administration & dosage  
  Abstract OBJECTIVES: A fixed combination of long-acting beta(2)-agonists (LABA) plus inhaled corticosteroids (ICS) has never been proven to reduce asthma exacerbations vs ICS alone in children. This 12-month, double-blind, randomized study in 341 children (age range, 4 to 11 years) with asthma uncontrolled on ICS investigated whether a novel regimen using budesonide/formoterol for maintenance and reliever therapy (Symbicort maintenance and relief therapy [SMART]) [Symbicort; AstraZeneca R&D, Lund, Sweden] could reduce exacerbations. METHODS: Patients received SMART (budesonide/formoterol 80/4.5 microg qd maintenance plus additional inhalations for symptom relief), budesonide/formoterol 80/4.5 microg qd for maintenance (fixed combination), or higher-dose budesonide 320 microg qd (fixed-dose budesonide). Blinded as-needed medication (terbutaline 0.4 microg) was provided in both fixed-dose groups. RESULTS: SMART prolonged the time to first exacerbation vs fixed-dose budesonide (p = 0.02) and fixed-dose combination (p < 0.001). Rates of exacerbation requiring medical intervention were reduced by 70 to 79% with SMART vs fixed-dose budesonide and fixed-dose combination (0.08/patient vs 0.28/patient and 0.40/patient, respectively; both p < 0.001). Mild exacerbation days and awakenings were significantly lower with SMART; yearly growth improved by 1.0 cm vs fixed-dose budesonide (p < 0.01). CONCLUSION: The SMART regimen using budesonide/formoterol for both maintenance and as-needed symptom relief reduces the exacerbation rate compared with both fixed-dose combination and higher fixed-dose ICS alone in children with asthma.  
  Address Danish Pediatric Asthma Center, Department of Pediatrics, Copenhagen University Hospital, Gentofte, DK-2900 Copenhagen, Denmark. bisgaard@copsac.dk  
  Corporate Author Thesis  
  Impact Factor 07,483 First Author Bisgaard, H. Editor  
  Language English Summary Language Original Title  
  Series Editor Series Title Abbreviated Series Title  
  Series Volume Series Issue Senior Author Hultquist, C.  
  ISSN 0012-3692 ISBN Medium  
  Area Expedition Conference  
  Notes PMID:17166990 Approved no  
  Call Number Serial 108  
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