NCT02074059

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 21, 2017

Completed
Last Updated

April 21, 2017

Status Verified

March 1, 2017

Enrollment Period

1.7 years

First QC Date

February 25, 2014

Results QC Date

December 21, 2016

Last Update Submit

March 10, 2017

Conditions

Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (4)

  • Peri-Dosing Events

    Pre-specified adverse events that occured during treatment administration; does not include nCPAP alone

    Within 48 Hours after Initiation of Study Treatment

  • All Cause Mortality

    Within 36 Weeks PMA

  • Oxygen Saturation Levels

    Oxygen saturation as determined by pulse oximetry

    Within 3 Hours of Randomization

  • Serum Electrolytes

    24 Hours Post Randomization

Secondary Outcomes (1)

  • PCO2

    Within 3 Hours of Randomization

Study Arms (6)

Aerosolized lucinactant (25 mg/kg)

EXPERIMENTAL

25 mg total phospholipids (TPL)/kg: Lucinactant for inhalation with nCPAP

Drug: Lucinactant for Inhalation

Aerosolized lucinactant (50 mg/kg)

EXPERIMENTAL

50 mg TPL/kg: Lucinactant for inhalation with nCPAP

Drug: Lucinactant for Inhalation

Aerosolized lucinactant (75 mg/kg)

EXPERIMENTAL

75 mg TPL/kg: Lucinactant for inhalation with nCPAP

Drug: Lucinactant for Inhalation

Aerosolized lucinactant (100 mg/kg)

EXPERIMENTAL

100 mg TPL/kg: Lucinactant for inhalation with nCPAP; repeat dosing possible if criteria met.

Drug: Lucinactant for Inhalation

Aerosolized lucinactant (150 mg/kg)

EXPERIMENTAL

150 mg TPL/kg: Lucinactant for inhalation with nCPAP; repeat dosing possible if criteria met.

Drug: Lucinactant for Inhalation

nCPAP alone

ACTIVE COMPARATOR

nCPAP therapy alone

Device: nCPAP alone

Interventions

Lucinactant for InhalationDRUG

Lucinactant for Inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)

Also known as: Aerosurf
Aerosolized lucinactant (100 mg/kg)Aerosolized lucinactant (150 mg/kg)Aerosolized lucinactant (25 mg/kg)Aerosolized lucinactant (50 mg/kg)Aerosolized lucinactant (75 mg/kg)
nCPAP aloneDEVICE

nCPAP therapy

Also known as: nasal continuous positive airway pressure
nCPAP alone

Eligibility Criteria

Age29 Weeks - 34 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

Location

Christiana Care Health System

Newark, Delaware, 19713, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Riley Hospital for Children at IU Health

Indianapolis, Indiana, 46202, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Mid Atlantic Neonatology Associates

Morristown, New Jersey, 07960, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

lucinactantInhalationContinuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Respiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaPositive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Results Point of Contact

Title
Executive Director, Biostatistics & Data Management
Organization
Windtree Therapeutics, Inc.
psimmons@windtreetx.com
215-488-9300

Study Officials

  • Robert Segal, MD, FACP

    Windtree Therapeutics, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Sequential escalating dosing groups, each group contained an active and control arm of equal size.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2014

First Posted

February 28, 2014

Study Start

February 1, 2014

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

April 21, 2017

Results First Posted

April 21, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(11)