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Budesonide/formoterol maintenance and reliever therapy: impact on airway inflammation in asthma

¹ Dept of Medicine, McMaster University, Hamilton, ⁴ Family Physician Airways Group of Canada, Richmond Hill, ⁵ Medical Affairs, AstraZeneca Canada Inc., Mississauga, ON, ² Institute of Cardiology and Pneumology, Laval University, Hospital Laval, Quebec City, PC, and ³ Dept of Respiratory Medicine, University of British Columbia, Vancouver, BC, Canada.

CORRESPONDENCE: M. R. Sears, Firestone Institute for Respiratory Health, St Joseph's Healthcare, 50 Charlton Avenue East, Hamilton, Ontario, L8N 4A6 Canada. Fax: 1 9055216132. E-mail: searsm{at}mcmaster.ca

Keywords: Asthma, budesonide/formoterol, control, exacerbations, health economics, inflammation

Received: August 10, 2007
Accepted January 4, 2008

The aim of the present study was to compare the effectiveness, safety and health economics of budesonide/formoterol maintenance and a novel reliever therapy with conventional best practice in patients with persistent asthma in Canada.

After 2 weeks of usual therapy, 1,538 patients were randomised for 6 months to open-label budesonide/formoterol maintenance and reliever therapy 160/4.5 µg twice daily and as needed, or to guideline-based conventional best practice. Severe asthma exacerbations, reliever medication use and total inhaled corticosteroid dose were analysed in all patients and airway inflammation was assessed in a sub-study of 115 patients.

No differences were seen in time to first severe exacerbation and severe asthma exacerbation rate. There were numerically fewer emergency room visits or hospitalisations with budesonide/formoterol maintenance and reliever therapy (4.4 versus 7.5 events per 100 patients·yr^–1, 41% reduction); however, this did not reach statistical significance. Mean total inhaled corticosteroid dose, reliever use, asthma medication costs and total annual costs per patient were all significantly lower with budesonide/formoterol maintenance and reliever therapy. Mean sputum eosinophil cell counts remained in the range for controlled inflammation in both groups.

In conclusion, budesonide/formoterol maintenance and reliever therapy achieved similar or improved clinical control compared with conventional best practice, with significantly lower total inhaled corticosteroid dose and lower cost, while maintaining similar control of eosinophilic inflammation.