Success story in Otolaryngology

Therapeutic area: Bacterial Rhinosinusitis

 

Acute bacterial rhinosinusitis (ABRS) is defined as an inflammation or infection of the mucosa of the nasal passages. It is a common disorder both in children and adults. ABRS is on one of the most commonly encountered deceases, and an estimated 10 millions cases occur annually in Russia and approximately 3 millions in Ukraine.

 

Study sponsored by: a leading European pharmaceutical company
Study description: adult patients with acute bacterial rhinosinusitis, 10-days treatment period.
Study design: phase III, multicenter, randomized, double blind, parallel-groups study.
Number of involved countries: 5 European countries
Planned randomized patients for 5 countries: 284 patients
Client goal: enrollment of additional 15 subjects in Ukraine during 15 days.
Challenge: complex protocol
Number of sites in Ukraine: 1 site.

 

Results:
1. The recruitment program exceeded expectations of the client, enrolling 15 subjects in only 10 days.
The sponsor thanked the investigator for granting his support for the study in spite of the short time of his disposal.

 

 

 

2. ESMAR had the lowest percentage of queries in relation to the number of enrolled subjects - 12.4 %, compared to four other European countries. The audit sponsor congratulated Ukrainian CRAs for the high quality results and thanked ESMAR for its participation in this project.