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Author O'Byrne, P.M.; Bisgaard, H.; Godard, P.P.; Pistolesi, M.; Palmqvist, M.; Zhu, Y.; Ekstrom, T.; Bateman, E.D. url  doi
  Title Budesonide/formoterol combination therapy as both maintenance and reliever medication in asthma Type
  Year (down) 2005 Publication American Journal of Respiratory and Critical Care Medicine Abbreviated Journal Am J Respir Crit Care Med  
  Volume 171 Issue 2 Pages 129-136  
  Keywords Adolescent; Adrenergic beta-Agonists/*administration & dosage/adverse effects/pharmacology; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents/*administration & dosage/adverse effects/pharmacology; Asthma/*drug therapy; Budesonide/*administration & dosage/adverse effects/pharmacology; Child; Child, Preschool; Double-Blind Method; Drug Combinations; Ethanolamines/*administration & dosage/adverse effects/pharmacology; Female; Formoterol Fumarate; Humans; Male; Metered Dose Inhalers; Middle Aged; Peak Expiratory Flow Rate/drug effects; Proportional Hazards Models; Regression Analysis; Safety  
  Abstract Asthma control is improved by combining inhaled corticosteroids with long-acting beta2-agonists. However, fluctuating asthma control still occurs. We hypothesized that in patients receiving low maintenance dose budesonide/formoterol (bud/form), replacing short-acting beta2-agonist (SABA) reliever with as-needed bud/form would provide rapid symptom relief and simultaneous adjustment in antiinflammatory therapy, thereby reducing exacerbations. In this double-blind, randomized, parallel-group study, 2,760 patients with asthma aged 4-80 years (FEV1 60-100% predicted) received either terbutaline 0.4 mg as SABA with bud/form 80/4.5 microg twice a day (bud/form + SABA) or bud 320 microg twice a day (bud + SABA) or bud/form 80/4.5 microg twice a day with 80/4.5 microg as-needed (bud/form maintenance + relief). Children used a once-nocte maintenance dose. Bud/form maintenance + relief prolonged time to first severe exacerbation (p < 0.001; primary endpoint), resulting in a 45-47% lower exacerbation risk versus bud/form + SABA (hazard ratio, 0.55; 95% confidence interval, 0.44, 0.67) or bud + SABA (hazard ratio, 0.53; 95% confidence interval 0.43, 0.65). Bud/form maintenance + relief also prolonged the time to the first, second, and third exacerbation requiring medical intervention (p < 0.001), reduced severe exacerbation rate, and improved symptoms, awakenings, and lung function compared with both fixed dosing regimens.  
  Address Firestone Institute for Respiratory Health, St. Joseph's Hospital, Hamilton, Ontario, Canada.  
  Corporate Author Thesis  
  Impact Factor 12,996 First Author O'Byrne, P.M. Editor  
  Language English Summary Language Original Title  
  Series Editor Series Title Abbreviated Series Title  
  Series Volume Series Issue Senior Author Bateman, E.D.  
  ISSN 1073-449X ISBN Medium  
  Area Expedition Conference  
  Notes PMID:15502112 Approved no  
  Call Number Serial 178  
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