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Published ahead of print on November 27, 2002, doi:10.1164/rccm.200209-1116OC
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American Journal of Respiratory and Critical Care Medicine Vol 167. pp. 1232-1238, (2003)
© 2003 American Thoracic Society

Effects of Montelukast on Surrogate Inflammatory Markers in Corticosteroid-treated Patients with Asthma

Graeme P. Currie, Daniel K. C. Lee, Kay Haggart, Caroline E. Bates and Brian J. Lipworth

Asthma and Allergy Research Group, Ninewells Hospital and Medical School, University of Dundee, Dundee, Scotland, United Kingdom

Correspondence and requests for reprints should be addressed to Dr. Brian J. Lipworth, M.B.Ch.B., Asthma and Allergy Research Group, Ninewells Hospital and Medical School, University of Dundee, Dundee DD1 9SY, Scotland, UK. E-mail: b.j.lipworth{at}dundee.ac.uk

We evaluated whether montelukast conferred additive effects in patients with asthma receiving fluticasone/salmeterol (FP/SM) combination and FP alone. Twenty-two patients with mild to moderate asthma completed a double-blind, placebo-controlled study. After a 2-week run-in using FP 250 µg/SM 50 µg 1 puff twice daily, patients entered a randomized crossover period to receive additional montelukast 10 mg daily or placebo for 3 weeks each. For the first 2 weeks, they received FP/SM 1 puff BID, and then they received FP 250 µg 1 puff BID for the 3rd week. The primary outcome was adenosine monophosphate challenge threshold and recovery time; secondary outcomes included surrogate inflammatory markers and lung function. Compared with FP/SM run-in, adding montelukast to FP/SM was better (p < 0.05) than placebo for inflammatory markers but not for lung function. For adenosine monophosphate threshold, recovery, exhaled nitric oxide, and blood eosinophils, there were 1.4 (95% confidence interval, 1.1–1.8) geometric mean fold, 10 minutes (3–17 minutes), 2.1 parts per billion (0.2–3.9 parts per billion), and 88 (34–172) x 106/L differences, respectively. The combination of FP plus montelukast was superior to FP/SM for inflammatory markers but was inferior for lung function. Thus, in patients taking FP/SM or FP, montelukast conferred complimentary effects on surrogate inflammatory markers, which were dissociated from lung function. Further studies are required to evaluate whether these effects of montelukast translate into clinical benefits.

Key Words: asthma therapy • leukotriene receptor antagonist • salmeterol • fluticasone




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