Hanmi Pharmaceutical's Monterizine Chewable Tab., a combination drug of montelukast and levocetirizine, showed superior efficacy and safety compared to montelukast alone in pediatric patients with perennial allergic rhinitis, a study showed.
Hanmi Pharmaceutical said on Monday it presented the results of the phase 4 clinical trial of the combo drug at the joint congress of the American Academy of Allergy, Asthma & Immunology (AAAAI) and the World Allergy Organization (WAO), held from Feb. 28 to March 3 in San Diego, the U.S.
Professor Kim Chang-keun of the Asthma and Allergy Center at Inje University Sanggye Paik Hospital explains the details of the phase 4 study of Monterizine to an attendee at the 2025 AAAAI & WAO Joint Congress in San Diego, the U.S., on March 1. (Courtesy of Hanmi Pharmaceutical)
The study was presented by Professor Kim Chang-keun of the Asthma and Allergy Center at Inje University Sanggye Paik Hospital and the results were published in AAIR, an English-language journal jointly published by the Korean Academy of Pediatric Allergy and Respiratory Disease and the Korean Academy of Asthma, Allergy and Clinical Immunology, in November last year.
The study randomized 147 pediatric patients aged 6 to 14 years with perennial allergic rhinitis to receive Monterizine (montelukast 5 mg + levocetirizine 5 mg) or montelukast monotherapy 5 mg, and compared the efficacy and safety of the two groups.
After four weeks of treatment, the Monterizine group showed significantly greater improvement from baseline in daytime and nighttime epistaxis (nasal congestion) and daytime rhinorrhea (runny nose) symptoms than the montelukast monotherapy group. The Monterizine group also had statistically significantly higher scores on quality of life and symptom improvement questionnaires after four weeks of treatment.
“The efficacy and safety of the combination of montelukast and levocetirizine was confirmed in pediatric patients with perennial allergic rhinitis,” said Kim. ”The use of Monterizine, a leukotriene modulator and antihistamine combination, should be considered for pediatric and adolescent patients with allergic rhinitis with asthma.”
Monterizine, which Hanmi Pharmaceutical launched in 2018 as a strawberry-flavored chewable tablet, is a prescription drug for pediatric patients with allergic rhinitis with asthma. It was developed to make it easier for children to take and to allow for customized prescriptions that take into account patient age-specific characteristics.