OCT is happy to announce that the first patient has been enrolled into the phase III respiratory clinical trial sponsored by a leading world-known pharmaceutical company.
This is a prospective, multicenter, international, randomized, placebo-controlled, double-blind phase III trial conducted in two parallel groups. Study patients are children with recurrent upper-respiratory tract infections (RURTI) with high risk of recurrence.
This pediatric study is conducted in 5 countries including Russia where OCT is providing assistance from preparation of some of the study documents and regulatory support to project management including logistics, medical monitoring, safety reporting and study closure activities.
The total of 1000 patients is to be enrolled for the current study at about 65 medical centres worldwide. 200 of them are under OCT responsibility and will be enrolled at the seven medical sites in Russia.
The purpose of this study is to assess the efficacy and safety of the investigational drug given to the children aged between 3 and 4 years with a high risk of recurrence of URTI (at least 6 documented episodes in one year and presence of risk factors) during 6 months according to the approved therapeutic dosage of the product.
The secondary objective is to evaluate the consequences of URTI on absenteeism (children and parents), hospitalization, use of other treatments for children as well as to evaluate the ENT (ear, nose and throat) and broncho-pulmonary complications of URTI.
Upper Respiratory Tract Infection (URTI) is a non-specific term which usually describes the common cold (or coryza), laryngitis, pharyngitis/tonsillitis, acute rhinitis, acute rhinosinusitis, and acute otitis media (AOM).
Most URTI have a viral etiology, but a bacterial infection can arise during or after the viral episode. URTI occur more frequently in childhood and during the cold winter months.
These infections are a cause of frequent morbidity. Although rarely life-threatening, URTI complications such as broncho-pulmonary diseases (bronchiolitis, asthma) or chronic otitis are reported frequently, representing 29% to 60% of all URTI episodes. URTI are defined as infectious episode characterised by local functional and/or physical ear nose throat (ENT) and/or pharyngeal signs (sore throat, rhinorrhea, nasal discharge, auricular pain, cough, dysphagia, cervical lymph nodes) and fever ≥ 38,5 °C.
Recurrent URTI (RURTI) are defined as at least 6 episodes of URTI in one year.
RURTI is a situation to be considered by the physician, in order to improve the patient's (and family’s) quality of life and reduce the risk of deleterious complications. From a physician’s point of view, one critical population to follow-up and manage is that of pre-school children with RURTI.
OCT has sound expertise in the therapeutic area of otolaryngology and respiratory diseases: more than 10 phase II to IV clinical trials have been conducted during the past 3 years, two of which were pediatric.