Chest
Worldwide Clinical Experience With the First Marketed Leukotriene Receptor Antagonist
Section snippets
PRANLUKAST CLINICAL DEVELOPMENT PROGRAM—INITIAL CLINICAL STUDIES CONDUCTED IN JAPAN
The initial challenge studies and clinical safety and efficacy studies of pranlukast in the treatment of asthma conducted in Japan documented the activity of single and repeated doses in attenuating immediate and late airway responses to various provocations.14, 15, 16 Doses of pranlukast ranging from 150 to 900 mg were studied; the most common dosage used was 225 mg bid. Studies lasted from 4 to 36 weeks.
Data reported in the pivotal study of pranlukast vs azelastine are representative of data
PRANLUKAST CLINICAL DEVELOPMENT PROGRAM—EXPANSION INTO EUROPE AND NORTH AMERICA
As the clinical development program for pranlukast expanded into Europe and North America, the need to redefine the optimal dosage range for pranlukast was recognized. European and North American patients differ from Japanese patients in body surface area and body weight. Accordingly, an LTD4 challenge study conducted in Europe used higher dosages and repeated-dose administration of pranlukast (450 mg bid for 5 days).17 In addition, phase 2B studies were conducted in Europe and North America to
STUDIES IN SEASONAL ALLERGIC RHINITIS
As noted, researchers have found that leukotrienes play a critical role as inflammatory mediators throughout the upper and lower airway.1, 2, 3, 4, 5, 6, 7, 8 Because of this, researchers and clinicians have begun to view inflammatory airway disease—including asthma and allergic rhinitis—as a continuum of inflammation rather than as separate, distinct diseases. Consistent with this evolving perspective, pranlukast is being evaluated not only as a novel treatment for asthma but also as a
CONCLUSIONS
Considerable experience has been gained with pranlukast worldwide, and the data generated so far on its clinical pharmacology, efficacy, and safety indicate that LTRAs such as pranlukast hold great promise as important therapeutic advances in the treatment of patients who have inflammatory airway disease. Recent challenge studies conducted in Europe and North America have built on the wealth of experience already available in Japan and have found that pranlukast inhibits bronchoconstriction due
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