Introduction:\nPranlukast is a leukotriene receptor antagonist (LTRA) that is used as an additional controller of mild to moderate asthma. This study\ncompared the efficacy and side effects of two bioequivalent preparations of pranlukast: original pranlukast (OnonÃ?®; Ono\nPharmaceutical, Japan) and a modified formulation of pranlukast (PrakanonÃ?®; Yuhan Co, Korea) in patients with mild to moderate\nasthma.\nMethods:\nOf the 34 subjects screened, 30 patients who were using standard medication to control asthma and scored less than 20 points on the\nAsthma Control Testââ??¢ (ACT) were assigned randomly to one of the two groups in a prospective, open label, crossover study: group 1\nreceived PrakanonÃ?® (150 mg/day) and group 2 received OnonÃ?® (450 mg/day) for 8 weeks each; after a 1-week rest period, the groups\nwere switched to the alternative medication for further 8 weeks and monitored for 2 more weeks without study medication.\nEvaluation parameters included the ACT, quality of life questionnaire adult Korean asthmatics (QLQAKA), pulmonary function\ntests, peripheral blood tests, vital signs, and adverse events.\nResults:\nThirty patients were enrolled and 21 completed the trial: 10 in group 1 and 11 in group 2. The baseline data of the two groups did not\ndiffer. No statistical significant differences were observed in efficacy and lung function at each time and in changes from baseline\nvalue between the two kinds of pranlukast. The final asthma control rate was 81% with PrakanonÃ?® and 76% with OnonÃ?®. There were\nno differences in vital signs and laboratory data at each time and in changes from baseline value between the two drugs. There were\nno differences in adverse events between the two drugs. The most common side effect was abdominal pain. Drug compliance was\nhigh, without differences between the two drugs.\nConclusion:\nThese findings suggest that PrakanonÃ?® which is an improved formulation of pranlukast at a lower dose than the original formulation,\nOnonÃ?®, has a similar efficacy and side effect profile in the control of persistent asthma.
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