Other Clinical Trial - Safety, Pk & Anti-inflammatory Effects of CC10

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Bronchopulmonary Dysplasia
Premature Birth
Respiratory Distress Syndrome in Premature Infant
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Syndrome

Clinical Trial Details

NCT number	NCT01473264
Study type	Interventional
Source	Clarassance, Inc.
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	January 2000
Completion date	December 2003

View Details

See also
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Terminated	`NCT05030012` - Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants	N/A
Completed	`NCT00006058` - Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns	N/A
Completed	`NCT00005376` - Premature Birth and Its Sequelae in Women	N/A
Completed	`NCT00011362` - Dexamethasone Therapy in VLBW Infants at Risk of CLD	Phase 3
Completed	`NCT00004805` - Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death	N/A
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Safety, Pk and Anti-inflammatory Effects of CC10 Protein in Premature Infants With Respiratory Distress Syndrome (RDS)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms