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Am. J. Respir. Crit. Care Med., Volume 161, Number 3, March 2000, 996-1001

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

JOHAN C. KIPS, BRIAN J. O'CONNOR, MARK D. INMAN, KLAS SVENSSON, ROMAIN A. PAUWELS, and PAUL M. O'BYRNE

Department of Respiratory Diseases, University Hospital Ghent, Ghent, Belgium; King's College, London, United Kingdom; Biostatistical Department, Astra Draco, Lund, Sweden; and Department of Respirology, McMaster University, Hamilton, Ontario, Canada

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 µg, twice daily), 60 patients with moderate asthma were randomly assigned to a 1-yr treatment with 400 µg of budesonide plus placebo, twice daily (BUD800), or 100 µg of budesonide plus 12 µg of formoterol, twice daily (BUD200+F). All drugs were administered via Turbuhaler. Budesonide (800 µg, 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. Kips JC, O'Connor BJ, Inman MD, Svensson K, Pauwels RA, O'Byrne PM. A long-term study of the antiinflammatory effect of low-dose budesonide plus formoterol versus high-dose budesonide in asthma.




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