Formoterol added to low-dose budesonide has no additional antiinflammatory effect in asthmatic patients.
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.
Overbeek
Shelley E
SE
Department of Pulmonary Medicine, SV020, Erasmus Medical Center, Dr. Molewaterplein 40, 3015 GD Rotterdam, Netherlands. s.e.overbeek@erasmusmc.nl
Mulder
Paul G
PG
Baelemans
Sophia M
SM
Hoogsteden
Henk C
HC
Prins
Jan-Bas
JB
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
D000318:Adrenergic beta-Agonists; D004983:Ethanolamines; D005938:Glucocorticoids; D019819:Budesonide; D000068759:Formoterol Fumarate