[Results of an open, randomized, actively controlled study of the efficacy and safety of the new drug Freinozole nasal spray (Phenylephrine + Cetyrizine) in patients with acute respiratory infection].

Abstract

The aim of the study was proof of efficacy and safety of the drug Frinozol nasal spray in patients with acute respiratory infection (acute rhinitis). PATIENTS AND METHODS: A randomized open-label study with active control included 134 ambulatory patients: men and women aged 18 to 65 years with acute upper respiratory tract infection (acute rhinitis) lasting no more than 48 hours before inclusion into the study. Patients were randomized in two groups: group 1 took Frinozol nasal spray 2 sprays per each nostril three times a day for 7 days, subjects randomized to the group 2 took Vibrocil at the same dose and treatment regimen. The primary efficacy endpoint in the study was assessment of the dynamics of symptoms such as nasal congestion, rhinorrhea, itching in the nose and hyposmia using 10 cm VAS in 1 day after the start of treatment compared to the baseline. Secondary endpoints included assessment of the dynamics of nasal symptoms after 7 days of treatment, changes in the values of the Congestion Quantifier 5, CQ-5 questionnaire and evaluation of the effectiveness by the investigator. Safety analysis was carried out throughout the study and included the assessment of adverse events, laboratory data, vital signs, ECG assessment. RESULTS: According to the results of the study and comparative analysis of the primary (assessment of the dynamics of nasal symptoms on a 10 cm visual analogue scale 1 day after the start of treatment) and secondary efficacy endpoints as well as a comprehensive safety analysis, it can be concluded that the study drug is not inferior to the reference drug. Thus, the new combination Frinozol nasal spray is an effective and safe treatment for patients with acute respiratory infections.