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31 Marburg University, Marburg, Germany, 2 Primary Care Lung Clinic, Toronto, Canada. 3 Ghent University Hospital, Ghent, Belgium. 4 Hospital Donostia, Donostia-San Sebastiàn, Spain. 5 Private Practice, Coventry, and 8 Dept of General Practice and Primary Care, University of Aberdeen, Aberdeen, UK, 6 Private Practice, Nantes, France 7 AstraZeneca, Lund, Sweden.
CORRESPONDENCE: C. Vogelmeier, Klinikum der Philipps-Universität Marburg, Baldingerstrasse, 35043 Marburg, Germany. Fax: 49 64212868987. E-mail: Claus.Vogelmeier{at}med.uni-marburg.de
Keywords: Asthma, budesonide/formoterol, salmeterol/fluticasone, Seretide®/Advair®, Symbicort®
Received: March 10, 2005
Accepted August 5, 2005
This 12-month dose-titration study assessed the effectiveness of budesonide/formoterol for maintenance plus relief with a control group using salmeterol/fluticasone for maintenance plus salbutamol for relief.
Adolescents and adults (n = 2,143; mean forced expiratory volume in one second (FEV1) 73% predicted; mean inhaled corticosteroid (ICS) 884 µg·day–1) were randomised to budesonide/formoterol 160/4.5 µg two inhalations b.i.d. plus additional inhalations as needed, or salmeterol/fluticasone 50/250 µg b.i.d. plus salbutamol as needed. Treatment was prescribed open label; after 4 weeks, physicians could titrate maintenance doses in accordance with normal clinical practice.
Maintenance plus as-needed budesonide/formoterol prolonged the time to first severe exacerbation versus salmeterol/fluticasone (25% risk reduction). The total number of severe exacerbations was significantly reduced in the budesonide/formoterol group (255 versus 329). Both regimens provided sustained improvements in symptoms, as-needed use, quality of life and FEV1, with differences in favour of the budesonide/formoterol group for as-needed use (0.58 versus 0.93 inhalations·day–1) and FEV1 (post-ß2-agonist values). Mean ICS dose during treatment was similar in both groups (653 µg budesonide·day–1 (maintenance plus as-needed) versus 583 µg fluticasone·day–1).
The simplified strategy using budesonide/formoterol for maintenance and reliever therapy is feasible, safe and at least as effective as salmeterol/fluticasone plus salbutamol.
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