title: A long-term study of the antiinflammatory effect of low-dose budesonide plus formoterol versus high-dose budesonide in asthma.
abstract: Adding inhaled long-acting beta(2)-agonists to a low dose of inhaled corticosteroids (ICS), results in better clinical asthma control than increasing the dose of ICS. However, this approach may mask underlying airway inflammation. In a double-blind parallel-group study, we evaluated the effect of adding formoterol to a low dose of budesonide, compared with a higher dose of budesonide, on the composition of induced sputum. After a 4-wk run-in period of treatment with budesonide (800 microg, twice daily), 60 patients with moderate asthma were randomly assigned to a 1-yr treatment with 400 microg of budesonide plus placebo, twice daily (BUD800), or 100 microg of budesonide plus 12 microg of formoterol, twice daily (BUD200+F). All drugs were administered via Turbuhaler. Budesonide (800 microg, twice daily) during run-in significantly reduced median sputum eosinophils from 4.5 to 0.68%. No significant changes in the proportion of eosinophils, EG2(+) cells, other inflammatory cells, or ECP levels in sputum were observed over the ensuing 1-yr treatment with BUD200+F or BUD800. Clinical asthma control was not significantly different between both groups. In conclusion, no significant differences in sputum markers of airway inflammation were observed during a 1-yr treatment with a low dose of inhaled budesonide plus formoterol compared with a higher dose of budesonide.
authors.affiliation: Department of Respiratory Diseases, University Hospital Ghent, Ghent, Belgium. johan.kips@rug.ac.be
authors.forename: J C
authors.initials: JC
authors.lastname: Kips
authors.forename: B J
authors.initials: BJ
authors.lastname: O'Connor
authors.forename: M D
authors.initials: MD
authors.lastname: Inman
authors.forename: K
authors.initials: K
authors.lastname: Svensson
authors.forename: R A
authors.initials: RA
authors.lastname: Pauwels
authors.forename: P M
authors.initials: PM
authors.lastname: O'Byrne
mesh_terms: D000318:Adrenergic beta-Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001249:Asthma / Q000188:drug therapy*; D019819:Budesonide / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004983:Ethanolamines / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D000068759:Formoterol Fumarate; D006801:Humans; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000318:Adrenergic beta-Agonists; D000893:Anti-Inflammatory Agents; D004983:Ethanolamines; D019819:Budesonide; D000068759:Formoterol Fumarate