The Jadran-Galenski laboratorij (JGL) pharmaceutical company is conducting the third phase of a multinational clinical trial of an innovative nasal spray for the cold, in which almost 500 patients from Germany, Poland, Bulgaria and Croatia will participate, the company reported on Monday.
The RhinnovateHA spray is an innovative combination of two active substances. The trial aims to prove that it has better efficacy, safety and tolerability compared to sprays with a single active substance or placebo.
JGL underscored that this is the first time a study of such scope and importance is being conducted in and financed from Croatia, representing a historic success and a significant step forward for the company and the Croatian pharmaceutical industry.
The researchers, otolaryngology specialists and key medical staff from 30 clinical centres in Germany, Croatia, Poland and Bulgaria, held a meeting in Opatija on the study protocol, procedures and regulatory framework for the implementation of the study.
The National Medicines Agency and the Central Ethics Committee have already approved the trial in Germany, and Croatia, Poland and Bulgaria are still in the approval process.
The test will be conducted on adult and adolescent patients suffering from acute viral rhinosinusitis, in cooperation with the German clinical research organisation ClinCompetence Cologne and under the guidance of a specialist in allergology, pulmonology and clinical immunology, Ralph Mösges, also a member of the Scientific Council of JGL.
Test results are expected at the beginning of next summer, and the spray will be on the market next year at the earliest.
In the last two years, JGL has doubled its investments in research and development, and this clinical study offers the possibility of multi-year patent and regulatory protection, the director of Scientific Operations at JGL, Zdravka Knezevic, said.
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