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Author Bisgaard, H.; Pedersen, S.S.; Nielsen, K.G.; Skov, M.; Laursen, E.M.; Kronborg, G.; Reimert, C.M.; Hoiby, N.; Koch, C. url  doi
  Title Controlled trial of inhaled budesonide in patients with cystic fibrosis and chronic bronchopulmonary Psuedomonas aeruginosa infection Type Journal Article
  Year (down) 1997 Publication American Journal of Respiratory and Critical Care Medicine Abbreviated Journal Am J Respir Crit Care Med  
  Volume 156 Issue 4 Pt 1 Pages 1190-1196  
  Keywords Administration, Inhalation; Anti-Bacterial Agents/therapeutic use; Anti-Inflammatory Agents/administration & dosage/adverse effects/*therapeutic use; Biomarkers; Bronchial Hyperreactivity/diagnosis/etiology/physiopathology; Bronchial Provocation Tests; Bronchopneumonia/complications/*drug therapy/microbiology; Budesonide/administration & dosage/adverse effects/*therapeutic use; Child; Chronic Disease; Cystic Fibrosis/complications/*drug therapy/metabolism; Double-Blind Method; Follow-Up Studies; Forced Expiratory Flow Rates; Histamine; Humans; Pseudomonas Infections/complications/*drug therapy/microbiology; Pseudomonas aeruginosa/*isolation & purification; Sputum/metabolism/microbiology; Treatment Outcome  
  Abstract The efficacy and safety of anti-inflammatory treatment with inhaled glucocorticosteroids in patients with cystic fibrosis (CF) and complicating chronic Pseudomonas aeruginosa (P.a.) lung infection was studied in a placebo-controlled, parallel, double-blind single center trial. Active treatment consisted of budesonide dry powder, 800 microg twice daily, delivered from a Turbuhaler. The study period covered two successive 3-mo intervals between elective courses of intravenous anti-Pseudomonas antibiotics. Fifty-five patients entered the study, with a mean age of 20 yr and a mean FEV1 of 63% of predicted. Analysis of all patients entered, irrespective of trial adherence (“intention to treat”), showed a decrease in FEV1 in the first period of -0.032 L in patients on budesonide versus -0.187 L in patients on placebo (p = 0.08). The corresponding figures for the patients adhering to the protocol during the first period were -0.017 L versus -0.198 L (p < 0.05, confidence interval of the difference: -0.035 to +0.327 L). For all patients entered, as well as for patients adhering to the trial, there was always a trend in favor of budesonide, as judged by changes in FEV1 and FVC in both 3-mo periods. None of the patients had asthma, but the patients on budesonide had a mean improvement in histamine reactivity of +1.15 dose steps over the entire 6-mo period, as opposed to +0.017 dose steps in patients on placebo (p < 0.05). There was also a significant (p = 0.01) correlation between pre-trial histamine reactivity and the change in FEV1 in the first period in patients on budesonide. We conclude that inhaled glucocorticosteroids can be of short-term benefit in patients with CF and chronic P.a. infection and that those patients most likely to benefit from this treatment are patients with hyperreactive airways. Prolonged studies in larger number of patients are necessary to determine the long-term efficacy of this treatment.  
  Address Department of Pediatrics, National University Hospital, Rigshospitalet, Copenhagen, Denmark  
  Corporate Author Thesis  
  Impact Factor 12,996 First Author Bisgaard, H. Editor  
  Language English Summary Language Original Title  
  Series Editor Series Title Abbreviated Series Title  
  Series Volume Series Issue Senior Author Koch, C.  
  ISSN 1073-449X ISBN Medium  
  Area Expedition Conference  
  Notes PMID:9351621 Approved no  
  Call Number Serial 271  
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