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* From the Asthma and Allergy Research Group, Department of Clinical Pharmacology & Therapeutics, Ninewells Hospital & Medical School, University of Dundee, Dundee, Scotland, UK.
Correspondence to: Brian J. Lipworth, Department of Clinical Pharmacology & Therapeutics, Ninewells Hospital & Medical School, University of Dundee, Dundee, Scotland, UK, DD1 9SY; e-mail: b.j.lipworth{at}dundee.ac.uk
Objective: We wished to evaluate whether the combination of a leukotriene receptor antagonist and long-acting ß2-agonist might confer additive beneficial effects in terms of bronchoprotection and bronchodilatation, in mild to moderate asthmatic patients who were suboptimally controlled on inhaled corticosteroids alone.
Methods: Twelve asthmatic
patients were enrolled into a single-blind, placebo-controlled,
crossover study, receiving additive therapy as either of the following:
(1) montelukast alone, 10 mg (ML10); (2) inhaled salmeterol
alone, 50 µg (SM50); (3) ML10 and
SM50; (4) ML10 and inhaled salmeterol, 100 µg
(SM100); or (5) placebo inhaler and tablet. Trough
measurements were made of adenosine monophosphate (AMP) bronchial
challenge (the provocative concentration of a drug [AMP] causing a
fall of 
20% in FEV1 [PC20]) as the
primary end point, and spirometry, following single doses of either
placebo or active treatments (12 h after salmeterol, and 24 h
after monteleukast, respectively).
Results: Compared to placebo, all active treatments led to significant improvements (p < 0.05) in geometric mean AMP-PC20: placebo, 42 mg/mL; ML10, 106 mg/mL; SM50, 115 mg/mL; ML10 and SM50, 183 mg/mL; and ML10 and SM100, 247 mg/mL. The effects of montelukast and salmeterol were numerically additive, with ML10 and SM100 being significantly different (p < 0.05) from ML10 alone. For mean FEV1 and forced expiratory flow rate between 25% and 75% of vital capacity, there were significant differences (p < 0.05) between both combination therapies vs ML10 alone.
Conclusions: Our results suggest additive benefits of a single dose of a long-acting ß2-agonist and leukotriene antagonist, in terms of bronchoprotection and bronchodilation. Further studies in more severe asthmatics are required to evaluate long-term clinical effects.
Key Words: adenosine monophosphate • asthma • ß2-adrenoceptor • bronchial hyperrreactivity • leukotriene receptor • montelukast • salmeterol
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