A Long-term Study of the Antiinflammatory Effect of Low-dose Budesonide Plus Formoterol versus High-dose Budesonide in Asthma

• Published in: American journal of respiratory and critical care medicine 2000-03, Vol.161 (3), p.996-1001
• Main Authors: KIPS, JOHAN C, O'CONNOR, BRIAN J, INMAN, MARK D, SVENSSON, KLAS, PAUWELS, ROMAIN A, O'BYRNE, PAUL M
• Format: Article
• Language: English
• Subjects: Adrenergic beta-Agonists - administration & dosage; Adrenergic beta-Agonists - adverse effects; Adult; Aged; Anti-Inflammatory Agents - administration & dosage; Anti-Inflammatory Agents - adverse effects; Asthma - drug therapy; Biological and medical sciences; Budesonide - administration & dosage; Budesonide - adverse effects; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Ethanolamines - administration & dosage; Ethanolamines - adverse effects; Female; Formoterol Fumarate; Humans; Long-Term Care; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Respiratory system; Treatment Outcome
• ISSN: 1073-449X; 1535-4970
• DOI: 10.1164/ajrccm.161.3.9812056

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.