Safety, Pk and Anti-inflammatory Effects of CC10 Protein in Premature Infants With Respiratory Distress Syndrome (RDS)
Status:
Completed
Trial end date:
2003-12-01
Target enrollment:
Participant gender:
Summary
Bronchopulmonary Dysplasia (BPD) is a multi-factorial disease process that is the end result
of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical
ventilation and infection. These conditions initiate an inflammatory response characterized
by elevated inflammatory cell infiltrates and proinflammatory cytokines that lead to the
development of significant acute and chronic lung injury.
The study drug, rhCC10, is a recombinant version of natural human CC10 protein. Native CC10
is produced primarily by non-ciliated respiratory epithelial cells, called Clara cells and is
the most abundant protein in the mucosal fluids in normal healthy lungs.
The purpose of this study was to evaluate the pharmacokinetics, safety, tolerability and
anti-inflammatory effects of a single intratracheal (IT) dose of rhCC10 to intubated
premature infants receiving positive pressure ventilation for treatment of respiratory
distress syndrome (RDS) to prevent long term respiratory complications referred to as
bronchopulmonary dysplasia, and, more recently, as chronic respiratory morbidity (CRM;
asthma, cough, wheezing, multiple respiratory infections).
CC10 regulates inflammatory responses and protects the structural integrity of pulmonary
tissue while preserving pulmonary mechanical function during various insults (eg. viral
infection, bacterial endotoxin, ozone, allergens, hyperoxia). Together these properties
suggest that administration of rhCC10 may help to facilitate development of normal airway
epithelia and prevent the inflammation that leads to CRM in these infants.