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Published online before print January 23, 2008
Eur Respir J 2008, doi:10.1183/09031936.00104007
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ORIGINAL ARTICLE

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

M.R. Sears 1*, L-P. Boulet 2, M. Laviolette 2, J.M. FitzGerald 3, T.R. Bai 3, A. Kaplan 4, N. Smiljanic-Georgijev 5, J.S-M. Lee 5

1 Dept of Medicine, McMaster University, Hamilton, ON, Canada
2 Hôpital Laval, Institut de cardiologie et de pneumologie de l'Université Laval, Quebec City, PQ, Canada
3 Dept of Respiratory Medicine, University of British Columbia, Vancouver, BC, Canada
4 Family Physician, Chairperson, Family Physician Airways Group of Canada, Richmond Hill, ON, Canada
5 Medical Affairs, AstraZeneca Canada Inc., Mississauga, ON, Canada

* To whom correspondence should be addressed. E-mail: searsm{at}mcmaster.ca.


   Abstract

To compare the effectiveness, safety and health economics of budesonide/formoterol maintenance and reliever therapy (Symbicort SMART®, AstraZeneca, Sweden) with conventional best practice in patients with persistent asthma in Canada.

After 2 weeks of usual therapy, 1538 patients were randomized for 6 months to open-label budesonide/formoterol maintenance and reliever therapy 160/4.5µg twice daily and as needed, or guideline-based conventional best practice. Severe asthma exacerbations, reliever medication use and total inhaled corticosteroid dose were analysed in all patients. Airway inflammation was assessed in a sub-study (n=115).

No differences were seen in time to first severe exacerbation and severe asthma exacerbation rate. There were numerically fewer emergency room visits/hospitalizations with budesonide/formoterol maintenance and reliever therapy (4.4 versus 7.5 events/100 patients·year-1; 41% reduction; p=0.09). 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 (all p<0.01). Mean sputum eosinophil cell counts remained in the range for controlled inflammation in both groups.

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.

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




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