Korea's Hanmi Pharmaceuticals Publishes Phase 3 Clinical Trial Results of Its Treatment for Allergic Rhinitis

Hanmi Pharmaceuticals, one of Korea's leading pharmaceutical company, has published phase three clinical trial results of “Monterizine Capsule,” a treatment complex for allergic rhinitis with asthma. Monterizine is a double layered complex that composes a combination of 100mg of leukotriene acceptor antagonist Montelukast and 5mg of the third-generation antihistamines LevocetrizineHCl.

The published study is a phase three clinical trial (HM-MOLZ-302) done by 22 institutions, including Professor Park Chun-shik at the Pulmonology Department of Soonchunyang University Hospital. The trial was done on 220 patients who have asthma and allergic rhinitis by administering Montelukast or Monterizine capsule to the subjects once a day for four weeks.

The results revealed that the Monterizine group showed bigger changes of the mean daytime nasal symptom score (MDNSS) in the last two weeks (third to fourth week) compared to the Montelukast group. Moreover, side effect wise, the two groups did not show any statistically significant difference.

The researchers of this clinical trial said, “The ingredients of Montelukast have shown a big improvement from the second-generation antihistamines in nasal obstruction, which is the main symptom of allergic rhinitis, and we expect a complementary effect in rhinitis treatment through taking it with Levocetrizine.” It added, “The domestic and international guidelines suggest co-administration of leukotriene acceptor antagonist with antihistamines for treatment of allergic rhinitis.”

Meanwhile, Hanmi Pharmaceuticals released “Monterizine Capsule,” an allergic rhinitis with asthma treatment complex made for adults over 15 in August 2017, followed by “Monterizine Chewable Tab” made for children and teenagers (age of six to 14) in July this year.