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

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Windtree Therapeutics
ClinicalTrials.gov Identifier:
NCT02074059
First received: February 25, 2014
Last updated: November 19, 2015
Last verified: November 2015
  Purpose
The primary objective of this study is to evaluate the safety and tolerability 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 29 to 34 Weeks PMA: Dose Escalation and Study Extension

Resource links provided by NLM:


Further study details as provided by Windtree Therapeutics:

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


Enrollment: 80
Study Start Date: February 2014
Study Completion Date: November 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerolized lucinactant (Low Dose)
Low Dose: 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 (Medium Dose)
Medium Dose: 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: 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, Extension 1)
High Dose, Extension 1: Lucinactant for inhalation with nCPAP; 1 repeat dose will be allowed if repeat dosing criteria are met.
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, Extension 2)
High Dose, Extension 2: Lucinactant for inhalation with nCPAP; 1 repeat dose will be allowed if repeat dosing criteria are met.
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:   29 Weeks to 34 Weeks   (Child)
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 90 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 30 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 and/or presumed clinical sepsis
  • Need for endotracheal intubation and mechanical ventilation
  • Has been administered: another investigational agent or exposure to an investigational 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, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, United States, 92123
United States, Delaware
Christiana Care Health System
Newark, Delaware, United States, 19713
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Indiana
Riley Hospital for Children at IU Health
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, New Jersey
Mid Atlantic Neonatology Associates
Morristown, New Jersey, United States, 07960
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oregon
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Sponsors and Collaborators
Windtree Therapeutics
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Robert Segal, MD, FACP Windtree Therapeutics
  More Information

Responsible Party: Windtree Therapeutics
ClinicalTrials.gov Identifier: NCT02074059     History of Changes
Other Study ID Numbers: 03-CL-1201  4R44HL107000-02 
Study First Received: February 25, 2014
Last Updated: November 19, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 25, 2016