05.Mar.2014

OCT completed enrolment in phase III respiratory infections clinical trial

OCT is happy to announce completion of enrolment in phase III respiratory infections clinical trial.

This is a pre-registration international, multi-center, randomized, parallel, three-arm placebo-controlled, partially blinded clinical trial – a comparison of therapeutic equivalence between the test and the reference formulation in subjects with sore throat associated with upper respiratory tract infections.

Approval for the clinical trial conduct was obtained by OCT end of September 2013, and the first patient was enrolled mid November 2013. The last patient was enrolled February, 20, 2014, which means that the total of 290 patients were enrolled in Russian Federation in the period of 2,5 months, which is a really significant dynamics. As a comparison, only 10 patients were enrolled in Slovenia for this study.

The primary objective of the discussed study was to demonstrate the therapeutic equivalence of the treatment effect between the test investigational drug (TIMP, lozenges) and the reference investigational medicinal product (RIMP, orosoluble tablets), which are the two formulations of fixed combination of the active ingredient.

Within this primary objective, the superiority of both TIMP and RIMP over placebo is to be demonstrated.

The secondary objective was to assess and demonstrate similar safety profile of TIMP in comparison with RIMP. 

The purpose was to provide the clinical data on the therapeutic adequacy of TIMP in the marketing authorization application setting.

Respiratory tract infections (RTIs) are any infection of the sinuses, throat, airways or lungs and are usually caused by viruses, but they can also be caused by bacteria.

Respiratory tract infections are divided into two groups: upper and lower.

Common upper respiratory tract infections include:

  • common cold  

  • tonsillitis (infection of the tonsils and tissues at the back of the throat)

  • sinusitis (infection of the sinuses)

  • laryngitis (infection of the larynx, or voice box) 

  • flu

A cough is the most common symptom of an upper RTI. Other symptoms include headaches, stuffy or runny nose, sore throat, sneezing and muscle aches.

As for common lower RTIs, they include:

  • flu (which can affect either the upper or lower respiratory tract)

  • bronchitis (infection of the airways)

  • pneumonia (infection of the lungs)

  • bronchiolitis (an infection of the small airways that affects babies and children younger than two)

  • tuberculosis (persistent bacterial infection of the lungs)

The main symptom of a lower RTI is also a cough, although it is usually more severe and you may bring up phlegm and mucus. Other possible symptoms are a tight feeling in your chest, increased rate of breathing, breathlessness and wheezing.

Respiratory diseases, including flu and other viral infections, are something that millions of people worldwide suffer from each year, and Russia is not an exception, taking into consideration the climate of our country. According to the statistics, only in Moscow 1.5 million people were diagnosed with viral infections and about 1000 with flu in 2013, which has shown 13.9% and 17.7% increase year-on-year, respectively.

According to the federal Centers for Disease Control and Prevention (CDC), flu seasons are generally unpredictable, although epidemics happen every year.