title: Efficacy and safety of budesonide inhalation powder (Pulmicort Turbuhaler) during 52 weeks of treatment in adults and children with persistent asthma.
abstract: BACKGROUND
  Inhaled corticosteroids are the agents of choice for treating persistent asthma.
  
  
  OBJECTIVE
  To evaluate the long-term efficacy and safety of budesonide inhalation powder (Pulmicort Turbuhaler) in patients with mild to severe persistent asthma.
  
  
  METHODS
  Patients (n=1133) received open-label budesonide (dose range, 100-800 microg b.i.d.) for 52 weeks following 2 weeks to 5 months of treatment in one of four double-blind, placebo-controlled studies. Patients, identified before the double-blind studies, included adults (n=249) not receiving corticosteroids, adults (n=384) and children (n=356) previously maintained on inhaled corticosteroids, and adults (n=144) previously maintained on oral corticosteroids.
  
  
  RESULTS
  Mean forced expiratory volume in 1 sec was 68.2% of predicted normal (n=1133) at baseline (mean from two visits before randomization), 74.4% (n=1132) at the end of double-blind treatment, 81.3% (n=971) at week 52, and 80.1% (n=1125) at last observation (including patients who discontinued early). Sixty-four patients maintained on oral corticosteroids before double-blind treatment entered the open-label study off oral corticosteroids, 58 of whom (91%) remained oral corticosteroid-free throughout the study. There was no evidence of basal or cosyntropin-stimulated hypothalamic-pituitary-adrenal axis function suppression, and the most commonly occurring adverse events were respiratory infection, sinusitis, and pharyngitis.
  
  
  CONCLUSIONS
  During this 52-week, open-label study, budesonide maintained the improved pulmonary function and decreased oral corticosteroid use observed during previous double-blind treatment and was well tolerated, supporting its long-term use in adults and children with mild to severe persistent asthma.
authors.affiliation: National Jewish Medical and Research Center, Denver, Colorado 80206, USA. tinkelmand@njc.org
authors.forename: David G
authors.initials: DG
authors.lastname: Tinkelman
authors.forename: Edwin A
authors.initials: EA
authors.lastname: Bronsky
authors.forename: Gary
authors.initials: G
authors.lastname: Gross
authors.forename: William F
authors.initials: WF
authors.lastname: Schoenwetter
authors.forename: Sheldon L
authors.initials: SL
authors.lastname: Spector
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy*; D019819:Budesonide / Q000008:administration & dosage* / Q000627:therapeutic use; D002648:Child; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D009330:Nebulizers and Vaporizers; D011208:Powders; D013997:Time Factors
chemical_list: D000893:Anti-Inflammatory Agents; D011208:Powders; D019819:Budesonide