In December 2012 OCT sent the final archive of the clinical study in pediatric acute bronchitis to the Sponsor’s head office in Germany. This was a randomized, active-controlled, double-blind, double-dummy, three treatment arms, and multicenter phase IV study to investigate improved benefit/risk ratio of phytotherapy vs. antibiotic therapy and of combination therapy vs. antibiotic therapy depending on procalcitonin (PCT) status in pediatric acute bronchitis with productive cough. The investigational product is a combination of herbs formulated to be used as an expectorant in the treatment of acute and chronic inflammatory diseases of the respiratory tract accompanied by cough and sputum formation. The overall goal of the study was to show that antibiotic prescription in children with acute bronchitis can be reduced.
Five of sixteen opened investigational sites in Yekaterinburg, Kazan, Kemerovo, Krasnoyarsk and Perm were the leaders in patients’ recruitment. 181 clinical study subjects have been enrolled in Russia since October 2011 through May 2012. In autumn patients received their final treatment and the sites have been closed. No SAEs have been observed within the study at Russian centers.
Within a new contract the study Sponsor additionally requested OCT to submit the final report to the regulatory authorities in January 2013.
The clinical study has been performed within the protocol, the standards of Good Clinical Practice (ICH E6), Declaration of Helsinki, Guidance on Statistical Principles for Clinical Trials of 1998, Detailed guidance on the collection, verification and presentation of adverse reactions reports (ENTR/CT 3) of 2006, Guidance on Choice of Control Groups (ICH E10), and all applicable national regulatory requirements (drug law and data protection law, etc., like Russian “Federal Law on Medicines” N 86- FZ).OCT has reasonable experience in pediatric clinical research. In Russia there are no special regulations of such trials. Due to the local law on medicines a study in children could be performed only after conducting Phase III in adults and must be secured by the preclinical research in immature animals. The studies could escape prior research in adults only if a drug is prescribed for infants. At OCT we have project managers who are experienced pediatricians. We would be happy to start collaboration with biotech and pharmaceutical companies developing safety and effective drugs for children.