Phase III study – Acute Bronchitis submitted for approval in Russia

A randomized prospective comparative, open, parallel group clinical study of the efficacy and safety of film-coated pills and oral solution of investigational drug in adults with acute bronchitis has recently been submitted to the Russian Ministry of Health for approval.

AmeRuss is providing full-service regulatory and investigational support including performance of all necessary regulatory activities, submissions to local ethics committees, execution of clinical trial agreements with investigational sites and principal investigators, as well as all activities related to project and financial management, development of project documentation, data and safety management, biostatistics and clinical monitoring.

Planned enrollment into this study is 200 patients.

Russia is represented by investigational sites in Moscow, Saint Petersburg, Ekaterinburg, Novosibirsk, Voronezh and Chelyabinsk.

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