Cystic Fibrosis Clinical Trial
Official title:
A Multicenter Prospective Randomized Comparative Study of Pharmacokinetics, Clinical Efficacy and Safety of Tigerase® (JSC GENERIUM, Russia) vs. Pulmozyme® (Hoffmann-La Roche, Switzerland) as Part of Complex Therapy in Patients With Cystic Fibrosis
It is a multicenter, open-label, randomized, parallel-group study of the efficacy and safety of Tigerase® compared Pulmozyme® in patients with Cystic Fibrosis
Cystic fibrosis (CF) is a common hereditary disease with an autosomal recessive type of
inheritance, characterized by systemic damage to the exocrine glands, mainly the
bronchopulmonary and gastrointestinal systems. CF is usually characterized by a severe course
and poor prognosis. The severity of the disease and the life expectancy of the patient with
CF is determined primarily by the state of the bronchopulmonary system; more than 90% of
patients die from lung diseases.
CF Pulmonary damage develops as a result of a gene mutation - cystic fibrosis transmembrane
regulator of ion conductivity Na and Cl (CFTR-cystic fibrosis transmembrane regulator). The
main function of CFTR is to regulate the transport of sodium and chlorine across the cell
membrane and is part of the cAMP-dependent chlorine channel. CFTR-protein dysfunction in the
bronchial tree epithelial cells leads to a blockage of the chlorine ions transport and an
increase in the sodium ions absorption, and impaired fluid secretion through the epithelial
cells apical membrane.
Dornase alpha, a human recombinant deoxyribonuclease 1 (rhDNase, rhDNase) hydrolyzes
extracellular DNA (viscous polyanion) that enters the sputum from destroyed neutrophils,
thereby reducing the adhesion and viscosity of sputum. In CF patients dornase alpha is used
as symptomatic therapy in combination with standard therapy in patients with a forced vital
capacity (FVC) index of at least 40% of the proper value.
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