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Effects of montelukast and beclomethasone on airway function and asthma control

      Abstract

      Background: Maintaining asthma control is a major objective of therapy. Traditionally, the effectiveness of asthma therapy has been judged primarily by its effect on airway function rather than on multiaspect asthma control. Objective: An inhaled corticosteroid and a leukotriene receptor antagonist were compared to determine whether they provided equivalent effects, as judged by days of asthma control. Methods: In a randomized, multicenter, double-blind, placebo-controlled, parallel-group study, asthmatic patients (n = 782) with FEV1 percent predicted values of between 50% and 85% and a weekly average β-agonist use of more than 2 puffs per day were randomized to receive montelukast (10 mg daily), beclomethasone (200 μg twice daily), or placebo treatment for 6 weeks in a double-dummy fashion. We examined the distribution of the primary end point: percentage of days of asthma control. Secondary end points included FEV1, albuterol use, occurrence of an asthma attack, asthma flare-up, rescue corticosteroid use, sustained asthma control, and adverse experiences. Results: The percentage of days of asthma control was almost identical between the montelukast and beclomethasone groups (98% overlap in the distribution). Montelukast was at least equal to beclomethasone, and both were greater than placebo on the basis of frequency of asthma attacks, asthma flare-ups, and rescue corticosteroid use. Beclomethasone had a greater effect than montelukast and both treatments were better than placebo at improving FEV1. Conclusions: Montelukast was as effective as beclomethasone, as judged by indices of clinical control other than FEV1. When evaluating the outcome of montelukast therapy, FEV1 might underestimate clinical effectiveness. (J Allergy Clin Immunol 2002;110:847-54.)

      Keywords

      Abbreviations:

      ICS (Inhaled corticosteroid)
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