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Published ahead of print on November 27, 2002, doi:10.1164/rccm.200209-1116OC

Am. J. Respir. Crit. Care Med., Volume 167, Number 9, May 2003, 1232-1238

A more recent version of this article appeared on May 1, 2003
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Submitted on October 3, 2002
Accepted on November 25, 2002

Effects of montelukast on surrogate inflammatory markers in corticosteroid treated asthmatics

Graeme P Currie1, Daniel K Lee1, Kay Haggart1, Caroline E Bates1, and Brian J Lipworth1*

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

* To whom correspondence should be addressed. E-mail: b.j.lipworth{at}dundee.ac.uk.

We evaluated whether montelukast conferred additive effects in asthmatics receiving fluticasone/salmeterol (FP/SM) combination and fluticasone (FP) alone. Twenty-two mild-to-moderate asthmatics completed a double blind placebo-controlled study. After a 2-week run-in using FP 250µg/SM 50µg 1 puff BID, patients entered a randomised crossover period to receive additional montelukast 10mg daily or placebo for 3-weeks each. For the 1st 2-weeks they received FP/SM 1 puff BID then FP 250µg 1 puff BID for the 3rd week. The primary outcome was adenosine monophosphate (AMP) challenge threshold and recovery time; secondary outcomes included surrogate inflammatory markers and lung function. Compared to FP/SM run-in, adding montelukast to FP/SM was better (p<0.05) than placebo for inflammatory markers but not lung function. For AMP threshold, recovery, exhaled nitric oxide and blood eosinophils there were (95% CI) 1.4 (1.1-1.8) geometric mean fold, 10 (3-17) minute, 2.1 (0.2-3.9) ppb and 88 (34-172) x106/L differences respectively. The combination of FP plus montelukast was superior to FP/SM for inflammatory markers but inferior for lung function. Thus, in patients taking FP/SM or FP, montelukast conferred complimentary effects upon 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: leukotriene receptor antagonist, fluticasone, salmeterol, asthma therapy




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