title: Oral glucocorticosteroid-sparing effect of budesonide administered by Turbuhaler: a double-blind, placebo-controlled study in adults with moderate-to-severe chronic asthma. Pulmicort Turbuhaler Study Group.
abstract: OBJECTIVE
  To determine the ability of budesonide via an inhaler (Pulmicort Turbuhaler; Astra Draco AB) to replace oral glucocorticosteroids (GCSs) in adult subjects with moderate-to-severe asthma.
  
  
  METHODS
  Double-blind, randomized, and placebo-controlled study, with parallel groups.
  
  
  METHODS
  Multicenter study in outpatient setting.
  
  
  METHODS
  Eighty men and 79 women, aged 20 to 69 years, with moderate-to-severe asthma and a mean FEV1 of 58.3% predicted normal. All subjects were receiving oral GCS treatment and 79% of subjects were also receiving inhaled beclomethasone dipropionate (BDP). The mean daily doses of prednisone at baseline, including converted dose of BDP, for the placebo, budesonide 400 microg, and budesonide 800 microg, respectively, were 19.7 mg, 19.5 mg, and 18.7 mg.
  
  
  METHODS
  After a 2-week baseline period, subjects entered a 20-week treatment period, during which the oral dose of prednisone was reduced by forced down-titration at 2-weekly intervals.
  
  
  RESULTS
  Subjects receiving 400 microg or 800 microg bid of budesonide achieved a significantly greater reduction (82.9% and 79.0% respectively) in oral GCS dose compared with placebo-treated subjects (27%; p<0.001). Two thirds of the subjects receiving budesonide were able to achieve sustained oral corticosteroid cessation, compared with 8% in the placebo group. Additionally, both doses of budesonide resulted in significant improvement in results of pulmonary function tests and asthma symptoms scores, and a significant decrease in the use of bronchodilator therapy. The mean plasma cortisol levels before and after adrenocorticotropic hormone stimulation increased most toward the normal range in the budesonide-treated groups compared with placebo-treated subjects.
  
  
  CONCLUSIONS
  Budesonide administered via Turbuhaler has a significant oral GCS-sparing capacity with maintained or improved asthma control in adult subjects with moderate-to-severe asthma.
authors.affiliation: Department of Medicine, National Jewish Medical and Research Center, Denver, CO 80206, USA.
authors.forename: H S
authors.initials: HS
authors.lastname: Nelson
authors.forename: I L
authors.initials: IL
authors.lastname: Bernstein
authors.forename: J
authors.initials: J
authors.lastname: Fink
authors.forename: T B
authors.initials: TB
authors.lastname: Edwards
authors.forename: S L
authors.initials: SL
authors.lastname: Spector
authors.forename: W W
authors.initials: WW
authors.lastname: Storms
authors.forename: D P
authors.initials: DP
authors.lastname: Tashkin
mesh_terms: D000280:Administration, Inhalation; D000284:Administration, Oral; D000287:Administration, Topical; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D001507:Beclomethasone / Q000008:administration & dosage; D019819:Budesonide / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D011241:Prednisone / Q000008:administration & dosage*; D012129:Respiratory Function Tests
chemical_list: D018927:Anti-Asthmatic Agents; D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D019819:Budesonide; D001507:Beclomethasone; D011241:Prednisone; D006854:Hydrocortisone