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Clinical Investigations: ASTHMA |

Additive Bronchoprotective and Bronchodilator Effects With Single Doses of Salmeterol and Montelukast in Asthmatic Patients Receiving Inhaled Corticosteroids*

Owen J. Dempsey, MD; Andrew M. Wilson, MD; Erika J. Sims, BSc; Catrina Mistry, RGN; Brian J. Lipworth, MD
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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@dundee.ac.uk



Chest. 2000;117(4):950-953. doi:10.1378/chest.117.4.950
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Objective: We wished to evaluate whether the combination of a leukotriene receptor antagonist and long-actingβ 2-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-actingβ 2-agonist and leukotriene antagonist, in terms of bronchoprotection and bronchodilation. Further studies in more severe asthmatics are required to evaluate long-term clinical effects.

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