E-TypeA Study of the Effects of the Selective CysLT1 Antagonist Montelukast on Bronchoconstriction and Airway Inflammation Induced by Inhalation of Leukotriene E4 in Subjects With Asthma

Date de début de l'étude : 1 mai 2012

Inclusion Criteria: Be aged 18-55 years inclusive Have a diagnosed history of asthma as defined by at least one of the following: response to standard asthma treatment episodic wheezing change in lung function over short periods of time Be a non-smoker for the last two years and a total of smoking less than 5 pack-years Display a positive methacholine challenge test as evidenced by a PD20 (provocative dose causing 20% fall in forced expiratory volume in one second) ≤ 3621 µg cumulated dose within 8 weeks prior to screening or at the screening visit. Have stable intermittent asthma, only using bronchodilator therapy as needed for the last 4 weeks. Produce FEV1 (forced expiratory volume in one second) ≥ 70 % of predicted - Exclusion Criteria: Any significant respiratory disease, other than asthma. Subjects with seasonal asthma may not be included if they are in their season. Use of: oral or inhaled glucocorticosteroid treatment for the last 4 weeks prior to inclusion or during the study inhaled long-acting or oral beta2-agonists, anticholinergic bronchodilators, antihistamines, theophyllines, chromones and antileukotrienes within 2 weeks of screening regular NSAIDs drugs that inhibit the enzyme CYP3A (e.g. ritonavir, azol, antifungals, macrolides) beta-blocking agents Upper or lower respiratory tract infection within 4 weeks before inclusion Evidence (from medical history or physical examination) of any disease that in the investigators mind would affect the results of the study, in particular liver disease and/or signs of liver function impairment Participating in another study in the four weeks prior to screening Females who are pregnant, intend to be or who are lactating Subjects with history of aspirin-sensitive respiratory disease -