title: Oral corticosteroid therapy in cystic fibrosis patients hospitalized for pulmonary exacerbation: a pilot study.
abstract: BACKGROUND
  We hypothesized that adding 5 days of prednisone to standard therapy for acute pulmonary exacerbations in patients with cystic fibrosis (CF) would result in a more rapid and greater increase in lung function.
  
  
  METHODS
  CF patients with an acute pulmonary exacerbation were randomized to receive oral placebo or prednisone, 2 mg/kg/d up to 60 mg, on days 1 to 5 in addition to standard therapy. Study evaluations on days 1 to 6, 14, and 42 included spirometry, glucose measurements, sputum analysis, and symptom scores.
  
  
  RESULTS
  Twelve subjects were randomized to each arm. The slope of FEV(1) between day 1 and day 6 did not differ between evaluable subjects in the prednisone vs placebo groups (52 mL/d vs 51 mL/d, respectively). Mean increase in FEV(1) percentage of predicted did not differ significantly between prednisone vs placebo groups (day 6 [mean +/- SD], 12.2 +/- 5.2% vs 8.1 +/- 10.5%; day 14, 14.7 +/- 8.8% vs 10.2 +/- 11.2%, respectively). Sputum inflammatory markers and symptom scores decreased between day 1 and day 14, but mean values did not differ between groups. Glucosuria occurred in six prednisone subjects, two of whom had hyperglycemia develop.
  
  
  CONCLUSIONS
  In this pilot study, addition of oral corticosteroids to standard CF pulmonary exacerbation therapy did not result in a statistically significant effect on lung function or sputum markers of inflammation. Based on a trend toward improvement in pulmonary function with prednisone therapy, we obtained information for power calculations for a definitive study: 250 randomized subjects are required to detect a four-percentage-point treatment effect in FEV(1) percentage of predicted at day 14 to discriminate between null and alternative hypotheses.
authors.affiliation: Section of Pediatric Pulmonology and Allergy, St. Christopher's Hospital for Children, Philadelphia, PA, USA
authors.forename: Mark
authors.initials: M
authors.lastname: Dovey
authors.forename: Moira L
authors.initials: ML
authors.lastname: Aitken
authors.forename: Julia
authors.initials: J
authors.lastname: Emerson
authors.forename: Sharon
authors.initials: S
authors.lastname: McNamara
authors.forename: David A
authors.initials: DA
authors.lastname: Waltz
authors.forename: Ronald L
authors.initials: RL
authors.lastname: Gibson
mesh_terms: D000328:Adult; D003550:Cystic Fibrosis / Q000188:drug therapy*; D018450:Disease Progression; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005541:Forced Expiratory Volume; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011241:Prednisone / Q000008:administration & dosage*; D013147:Spirometry
chemical_list: D005938:Glucocorticoids; D011241:Prednisone