Skip to main content
OpenTrials
Completed

NCT Number: NCT01473264

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Distress Syndrome in Premature Infant Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Infections Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pneumonia Pregnancy Complications Premature Birth Respiratory Tract Diseases Respiratory Tract Infections Urogenital Diseases Ventilator-Induced Lung Injury

Age range

24 week–29 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Christiana HealthCare Systems, Wilmington, Delaware, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Newborn infants were considered for the study if the following criteria were met:

  • Age < 24 hours;
  • Birthweight between 700 and 1,300 grams;
  • Gestational age greater than or equal to 24 weeks;
  • Diagnosis of neonatal RDS based on clinical and radiographic criteria;
  • Requiring intubation and mechanical ventilation for treatment of RDS;
  • Received at least one dose of surfactant 100 mg/kg (Survanta; Ross Laboratories);
  • Written informed consent from the infant's parent or legal guardian prior to enrollment of the patient and agrees to all study-related procedures and evaluations, including those required after hospital discharge.

Exclusion criteria

  • Major congenital abnormalities (chromosomal, genetic, cardiac, pulmonary, or renal);

Treatment and study plan

recombinant human CC10 (rhCC10)

Drug

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.

Other names: rhCC10, CC10, uteroglobin, Clara cell secretory protein, Clara cell 10 kDa protein

Placebo

Drug

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.

Primary outcomes

  1. Number and type of adverse events

    Time frame: Adverse events were monitored through 36 wks post-menstrual age (PMA) or hospital discharge

    All adverse events were monitored according to the NCI Common Toxicity Criteria. In addition, adverse events specific to, or likely to occur in, premature infants were also monitored, including apnea/bradycardia, sepsis (culture-confirmed), patent ductus arteriosus, retinopathy of prematurity, intraventricular hemorrhage, periventricular leukomalacia, and necrotizing enterocolitis (NEC).

Secondary outcomes

  1. Assessment of pulmonary inflammatory markers

    Time frame: Days 0-7

    Total cell and neutophil counts were performed on TAF fluids. In addition, a panel of cytokines were measured in TAF from patients at times 0, 1, and 2 days

  2. Total number of days on mechanical ventilation

    Time frame: Through 36 wks postmenstrual age or discharge

  3. Hospitalization at 36 weeks PMA

    Time frame: Through 36 wks postmenstrual age or discharge

  4. Chronic Respiratory Morbidity

    Time frame: 6 & 12 months postmenstrual age

    Physical exams and Bayley neurological exams were performed at 12 months PMA. Data pertaining to respiratory outcomes were collected at 6 and 12 months PMA.

Sponsors and collaborators

Lead sponsor

Clarassance, Inc.

Industry

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Safety and Tolerability of Recombinant Human Clara Cell 10kDa Protein (rhCC10) Delivered Intratracheally to Premature Neonates With Respiratory Distress Syndrome

Important dates

Study start
2000
Primary completion
2002
Study completion
2003
First posted
Nov 17, 2011
Registry last updated
Nov 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.