Efficacy and Safety of Modified Pranlukast (Prakanon(®)) Compared with Pranlukast (Onon(®)): A Randomized, Open-Label, Crossover Study

INTRODUCTION: Pranlukast is a leukotriene receptor antagonist (LTRA) that is used as an additional controller of mild to moderate asthma. This study compared the efficacy and side effects of two bioequivalent preparations of pranlukast: original pranlukast (Onon(®); Ono Pharmaceutical, Japan) and a modified formulation of pranlukast (Prakanon(®); Yuhan Co, Korea) in patients with mild to moderate asthma. METHODS: Of the 34 subjects screened, 30 patients who were using standard medication to control asthma and scored less than 20 points on the Asthma Control Test(™) (ACT) were assigned randomly to one of the two groups in a prospective, open label, crossover study: group 1 received Prakanon(®) (150 mg/day) and group 2 received Onon(®) (450 mg/day) for 8 weeks each; after a 1-week rest period, the groups were switched to the alternative medication for further 8 weeks and monitored for 2 more weeks without study medication. Evaluation parameters included the ACT, quality of life questionnaire adult Korean asthmatics (QLQAKA), pulmonary function tests, peripheral blood tests, vital signs, and adverse events. RESULTS: Thirty 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 differ. No statistical significant differences were observed in efficacy and lung function at each time and in changes from baseline value between the two kinds of pranlukast. The final asthma control rate was 81% with Prakanon(®) and 76% with Onon(®). There were no differences in vital signs and laboratory data at each time and in changes from baseline value between the two drugs. There were no differences in adverse events between the two drugs. The most common side effect was abdominal pain. Drug compliance was high, without differences between the two drugs. CONCLUSION: These findings suggest that Prakanon(®) which is an improved formulation of pranlukast at a lower dose than the original formulation, Onon(®), has a similar efficacy and side effect profile in the control of persistent asthma.