Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Discovery Laboratories, Inc.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Discovery Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT02074059
First received: February 25, 2014
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

The primary objective of this study is to evaluate the safety and tolerability of a single exposure of aerosolized surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses to preterm neonates 29 to 34 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS), compared to neonates receiving nCPAP alone.


Condition Intervention Phase
Respiratory Distress Syndrome
Other: Lucinactant for Inhalation
Device: nCPAP alone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open-Label, Controlled Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Preterm Neonates

Resource links provided by NLM:


Further study details as provided by Discovery Laboratories, Inc.:

Primary Outcome Measures:
  • Safety and Tolerability of Lucinactant for Inhalation [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
    Assessed during dosing by recording adverse reactions, oxygen saturation levels, and serum electrolytes; and following dosing by recording complications of prematurity and signs of worsening respiratory distress as evidenced by need for increased respiratory support and supplemental oxygen."


Estimated Enrollment: 42
Study Start Date: February 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerolized lucinactant low dose
Low Dose of lucinactant for inhalation with nCPAP
Other: Lucinactant for Inhalation
Lucinactant for Inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
Experimental: Aerosolized lucinactant middle dose
Middle dose of lucinactant for inhalation with nCPAP
Other: Lucinactant for Inhalation
Lucinactant for Inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
Experimental: Aerosolized lucinactant high dose
High dose of lucinactant for inhalation with nCPAP
Other: Lucinactant for Inhalation
Lucinactant for Inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
Active Comparator: nCPAP alone
nCPAP therapy alone
Device: nCPAP alone
nCPAP therapy
Other Name: nasal continuous positive airway pressure

  Eligibility

Ages Eligible for Study:   up to 21 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent from a legally authorized representative
  • Gestational age 29 to 34 completed weeks (34 weeks 6 days) post menstrual age (PMA)
  • Successful implementation of controlled nCPAP within 60 minutes after birth
  • Spontaneous breathing
  • Chest radiograph consistent with RDS
  • Need for moderate levels of supplemental oxygen and nCPAP to maintain oxygen saturation of 88% to 95% for at least 60 minutes within the first 21 hours after birth

Exclusion Criteria:

  • Heart rate that cannot be stabilized above 100 beats/minute within 5 minutes of birth
  • Recurrent episodes of apnea occurring after the initial newborn resuscitation period (ie, 10 minutes after birth) requiring intermittent positive pressure breaths using inflating pressures above the set CPAP pressure administered manually or mechanically through any patient interface
  • A 5 minute Apgar score < 5
  • Major congenital malformation(s) and cranial/facial abnormalities that preclude nCPAP, diagnosed antenatally or immediately after birth
  • Other diseases or conditions potentially interfering with cardiopulmonary function (eg, hydrops fetalis or congenital infection such as TORCH)
  • Known or suspected chromosomal abnormality or syndrome
  • Prolong rupture of membranes (PROM) > 2 weeks
  • Evidence of hemodynamic instability requiring vasopressors or steroids for hemodynamic support
  • Need for endotracheal intubation and mechanical ventilation
  • Has been administered: another investigational agent or exposure to a medical device, any other surfactant agent, steroid treatment after birth
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02074059

Locations
United States, California
Sharp Mary Birch Hospital for Women and Newborns Recruiting
San Diego, California, United States, 92123
Contact: Kathy Arnell, RNC-NIC    858-939-4966    Kathy.Arnell@sharp.com   
Principal Investigator: Anup Katheria, MD         
United States, Florida
University of Miami Recruiting
Maimi, Florida, United States, 33136
Contact: Carmen D'Ugard    305-585-6527    Cdugard@med.miami.edu   
Principal Investigator: Cristina Naverrete, MD         
United States, Indiana
Riley Hospital for Children, University of Indiana Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lucy Smiley, CCRC    317-278-7364    lcsmiley@iu.edu   
Principal Investigator: Shawn Ahlfeld, MD         
United States, Oregon
Providence St. Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225
Contact: Annie Migaki    503-476-6606    Evelyn.Migaki@providence.org   
Principal Investigator: Joseph W Kaempf, MD         
Sponsors and Collaborators
Discovery Laboratories, Inc.
Investigators
Principal Investigator: Robert Segal, MD, FACP Discovery Laboratories, Inc.
  More Information

No publications provided

Responsible Party: Discovery Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT02074059     History of Changes
Other Study ID Numbers: 03-CL-1201, 4R44HL107000-02
Study First Received: February 25, 2014
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on October 19, 2014