title: Formoterol added to low-dose budesonide has no additional antiinflammatory effect in asthmatic patients.
abstract: OBJECTIVE
  Adding inhaled long-acting beta2-agonists to a low dose of inhaled corticosteroids (ICSs) results in better asthma control than increasing the dose of ICSs. An important, but as yet unresolved, question is whether this is due to an additional reduction of airway inflammation.
  
  
  METHODS
  Double-blind, parallel-group trial.
  
  
  METHODS
  Forty asthma patients (FEV1, 50 to 90% predicted; provocative concentration of a substance [methacholine] causing a 20% fall in FEV1 of < 8 mg/mL; no ICSs in the last 4 weeks).
  
  
  METHODS
  Randomization to 8 weeks of treatment with 100 microg of budesonide bid plus placebo (BUD200) or 100 microg of budesonide bid plus 12 microg of formoterol (BUD200 + F). Then the dose of budesonide (BUD) was increased to 400 microg bid in both groups for another 8 weeks. Bronchial biopsy specimens were collected before, and after 8 and 16 weeks of treatment. Eosinophils (major basic protein [MBP]) and mast cells (tryptase) were analyzed by immunohistochemistry.
  
  
  RESULTS
  BUD200 reduced the MBP staining (p = 0.008) and tryptase staining (p = 0.048) in the epithelium compared to baseline levels. There were no significant differences between the BUD200 and BUD200 + F groups. In both groups, increasing the dosage of BUD to 800 microg had no significant additional antiinflammatory effect.
  
  
  CONCLUSIONS
  Our results demonstrate that BUD administered at a low dose has significant antiinflammatory effects in patients with mild asthma. No significant additional antiinflammatory effects could be demonstrated either by adding formoterol or by increasing the dose of BUD.
authors.affiliation: Department of Pulmonary Medicine, SV020, Erasmus Medical Center, Dr. Molewaterplein 40, 3015 GD Rotterdam, Netherlands. s.e.overbeek@erasmusmc.nl
authors.forename: Shelley E
authors.initials: SE
authors.lastname: Overbeek
authors.forename: Paul G
authors.initials: PG
authors.lastname: Mulder
authors.forename: Sophia M
authors.initials: SM
authors.lastname: Baelemans
authors.forename: Henk C
authors.initials: HC
authors.lastname: Hoogsteden
authors.forename: Jan-Bas
authors.initials: JB
authors.lastname: Prins
mesh_terms: D000280:Administration, Inhalation; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage*; D000328:Adult; D001249:Asthma / Q000188:drug therapy* / Q000276:immunology; D001980:Bronchi / Q000187:drug effects / Q000276:immunology; D019819:Budesonide / Q000008:administration & dosage*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004983:Ethanolamines / Q000008:administration & dosage*; D005260:Female; D000068759:Formoterol Fumarate; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011014:Pneumonia / Q000188:drug therapy / Q000276:immunology; D012129:Respiratory Function Tests
chemical_list: D000318:Adrenergic beta-Agonists; D004983:Ethanolamines; D005938:Glucocorticoids; D019819:Budesonide; D000068759:Formoterol Fumarate