Safety, Pk and Anti-inflammatory Effects of CC10 Protein in Premature Infants With Respiratory Distress Syndrome (RDS)
Condition: Respiratory Distress Syndrome in Premature Infant; Bronchopulmonary Dysplasia
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia; Premature Birth; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    


Intervention name(s): recombinant human CC10 (rhCC10); recombinant human CC10 (rhCC10); placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5 mg/kg rhCC10, single dose delivered intratracheally (IT). Treatment was delivered within four hours after surfactant treatment. Dose was delivered IT in two (2) equal aliquots via a premeasured feeding tube placed in the distal third of the endotracheal tube with the patient in the right and then left lateral decubitus position and 30 degrees of Trendelenburg.; 1.5 mg/kg rhCC10, single dose delivered intratracheally (IT). Treatment was delivered within four hours after surfactant treatment. Dose was delivered IT in two (2) equal aliquots via a premeasured feeding tube placed in the distal third of the endotracheal tube with the patient in the right and then left lateral decubitus position and 30 degrees of Trendelenburg; Half normal saline solution; single dose delivered intratracheally (IT). Treatment was delivered within four hours after surfactant treatment. Dose was delivered IT in two (2) equal aliquots via a premeasured feeding tube placed in the distal third of the endotracheal tube with the patient in the right and then left lateral decubitus position and 30 degrees of Trendelenburg.
Other intervention name(s): rhCC10; CC10; uteroglobin; Clara cell secretory protein; Clara cell 10 kDa protein; rhCC10; CC10; uteroglobin; Clara cell secretory protein; Clara cell 10 kDa protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: CC10; BPD; Bronchopulmonary dysplasia; premature infants; neonates; pulmonary inflammation; lung function; RDS