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Published ahead of print on October 22, 2004, doi:10.1164/rccm.200407-884OC
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American Journal of Respiratory and Critical Care Medicine Vol 171. pp. 129-136, (2005)
© 2005 American Thoracic Society
doi: 10.1164/rccm.200407-884OC

Original Article

Budesonide/Formoterol Combination Therapy as Both Maintenance and Reliever Medication in Asthma

Paul M. O'Byrne, Hans Bisgaard, Philippe P. Godard, Massimo Pistolesi, Mona Palmqvist, Yuanjue Zhu, Tommy Ekström and Eric D. Bateman

Firestone Institute for Respiratory Health, St. Joseph's Hospital, Hamilton, Ontario, Canada; COPSAC Clinical Research Unit, University Hospital of Copenhagen, Gentofte, Denmark; Hôpital Arnaud de Villeneuve, Service des Maladies Respiratoires and Bronchomotricité, Montpellier, France; Department of Critical Care, Section of Respiratory Medicine, University of Florence, Florence, Italy; Department of Respiratory Medicine and Allergology, Sahlgrenska University Hospital, Gothenburg, Sweden; Respiratory Department, Peking Union Medical College Hospital, Beijing, China; AstraZeneca R&D, Lund, Sweden; and University of Cape Town, Cape Town, South Africa

Correspondence and requests for reprints should be addressed to Paul M. O'Byrne, M.B., F.R.C.P.(C), Firestone Institute for Respiratory Health, St. Joseph's Hospital, 50 Charlton Avenue, East Hamilton, ON, L8N 4A6 Canada. E-mail: obyrnep{at}mcmaster.ca

Asthma control is improved by combining inhaled corticosteroids with long-acting ß2-agonists. However, fluctuating asthma control still occurs. We hypothesized that in patients receiving low maintenance dose budesonide/formoterol (bud/form), replacing short-acting ß2-agonist (SABA) reliever with as-needed bud/form would provide rapid symptom relief and simultaneous adjustment in antiinflammatory therapy, thereby reducing exacerbations. In this double-blind, randomized, parallel-group study, 2,760 patients with asthma aged 4–80 years (FEV1 60–100% predicted) received either terbutaline 0.4 mg as SABA with bud/form 80/4.5 µg twice a day (bud/form + SABA) or bud 320 µg twice a day (bud + SABA) or bud/form 80/4.5 µg twice a day with 80/4.5 µg as-needed (bud/form maintenance + relief). Children used a once-nocte maintenance dose. Bud/form maintenance + relief prolonged time to first severe exacerbation (p < 0.001; primary endpoint), resulting in a 45–47% lower exacerbation risk versus bud/form + SABA (hazard ratio, 0.55; 95% confidence interval, 0.44, 0.67) or bud + SABA (hazard ratio, 0.53; 95% confidence interval 0.43, 0.65). Bud/form maintenance + relief also prolonged the time to the first, second, and third exacerbation requiring medical intervention (p < 0.001), reduced severe exacerbation rate, and improved symptoms, awakenings, and lung function compared with both fixed dosing regimens.

Key Words: inhaled corticosteroids • long-acting ß2-agonists • management • single inhaler




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