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The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age

Primary Purpose

Respiratory Distress Syndrome

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lucinactant delivered via investigational delivery device
nCPAP
Sponsored by
Windtree Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome

Eligibility Criteria

26 Weeks - 32 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed informed consent form (ICF) from legally authorized representative
  2. 26 0/7 to 32 6/7 completed weeks gestation PMA
  3. Successful implementation of non-invasive support or ventilation within 90 minutes after birth
  4. Spontaneous breathing
  5. Chest radiograph consistent with RDS
  6. Within the first 20 hours after birth requires an nCPAP of 5 to 7 centimeters water (cmH2O) with a fraction of inspired oxygen (FiO2) of ≥ 0.25 (>0.21 for neonates 26-28 weeks PMA) to 0.40 that is clinically indicated for at least 30 minutes to maintain oxygen by pulse oximetry (SpO2) of 90% to 95%. Transient (<10 minutes) FiO2 excursions outside this range do not reset the 30-minute requirement.

Exclusion Criteria:

  1. A heart rate that cannot be stabilized above 100 beats per minute (bpm) within 5 minutes of birth
  2. Recurrent episodes of apnea requiring positive pressure ventilation (PPV) administered manually or mechanically through any patient interface
  3. A 5 minute Apgar score < 5
  4. Major congenital malformation(s) or craniofacial abnormalities that preclude the use of nCPAP, diagnosed antenatally or immediately after birth
  5. Clinically significant diseases or conditions other than RDS which could potentially interfere with cardiopulmonary function (e.g. congenital heart disease, hydrops fetalis or congenital infection)
  6. A known or suspected chromosomal abnormality or syndrome
  7. Premature rupture of membranes (PROM) > 3 weeks
  8. Hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis
  9. A need for intubation and/or mechanical ventilation at any time before enrollment into the study

  10. The administration (or plan for administration) of any the following:

    • Another investigational agent or investigational medical device
    • Any other surfactant agent
    • Systemic corticosteroids (other than antenatal steroids already received)
  11. Presence of air leak (pneumothorax, pneumomediastinum, pneumopericardium, subcutaneous emphysema, or definite evidence of pulmonary interstitial emphysema (PIE)) on the baseline chest radiograph

Sites / Locations

  • University of Alabama at Birmingham
  • Univ. of Arkansas Medical Center
  • Loma Linda University Medical Center
  • Children's Hospital of Orange County
  • Sharp Mary Birch Hospital for Women and Newborns
  • Christiana Care Health System
  • University of Miami Holtz Children's Hospital
  • University of Michigan Health System
  • University of Mississippi Medical Center
  • University of Nebraska Medical Center
  • Albany Medical Center
  • Morgan Stanley Childrens Hospital of New York Presbyterian (CHONY)
  • Duke University Medical Center
  • Brody School of Medicine at ECU
  • New Hanover Regional Medical Center
  • Case Western Reserve University (Rainbow Babies Hosp.)
  • Ohio State University
  • Providence St. Vincent Medical Center
  • Women and Infants Hospital
  • Baylor University Medical Center
  • Cook Children's Hospital
  • Texas Health Harris Methodist Hospital
  • Foothills Medical Centre
  • Royal Alexandra Hospital
  • Sunnybrook Health Sciences Centre
  • Montreal Children's Hospital
  • Sainte Justine Hospital
  • Hospital Dr Sotero Del Rio
  • Hospital Clínico Regional de Concepción Dr Guillermo Grant Benavente
  • Hospital San Jose
  • Clinica Alamena de Santiago
  • Hospital Santiago Oriente Dr Luis Tisné Brousse
  • Hospital Clinico de la Pontificia Universidad Catolica de Chile
  • Hospital San Juan de Dios
  • Fundacion Hospitalaria San Vicente de Paul
  • Hospital General de Medellin
  • Fundacion Valle Del Lili
  • Semmelweis Egyetem
  • Csolnoky Ferenc Korhaz
  • Debreceni Egyetem Klinikai Kozpont
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Okato
  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
  • Cork University Hospital
  • Mid-Western Regional Hospital Limerick
  • Erasmus Medical Center
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
  • S.U. nr2im. Dr. Jana Biziela Oddzial Kliniczny N. W. Z. Intensywna Terapia Noworodka wraz z Wgjazdowy m Zespolem N
  • Instytut Centrum Zdrowja Matki Polki Klinika Neonatologii
  • SP ZOZ Szpital Uniwersytecki w Krakowie, Oddzial Neonatologii
  • Szpital Kliniczny im. Ks, Anny Mazowieckiej Klinika Neonatologii
  • Uniwersyteckie Centrum Kliniczne
  • Szpital Spegialistycszny nr 2 w Bytomia Oddzial Noworodkow Blok V
  • Samodzielny Publiczny Specjalistczny Zaklad Opieki Zdrowotnej Zdroje
  • Ginekologiczno-Polozniczy Szpital Klinicznym UM im. Karola Marcinkowskiego w Poznan i u Katedra Neonatologii

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Aerosolized lucinactant (low dose)

Aerosolized lucinactant (high dose)

nasal CPAP

Arm Description

Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.

Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.

nCPAP alone

Outcomes

Primary Outcome Measures

Number of Participants With Respiratory Failure or Death Due to Respiratory Distress Syndrome (RDS)
Number of participants who had respiratory failure due to RDS or death due to RDS; known as nasal continuous positive airway pressure (nCPAP) failure

Secondary Outcome Measures

Incidence of Respiratory Failure or Death Due to RDS
Incidence of Respiratory Failure or Death Due to RDS by Intubation or Failure Criteria
Time to nCPAP Failure
Time from birth to nCPAP Failure
Incidence of Respiratory Failure or Death Due to RDS With Poisson Distribution Modeling
The measure tests the differences between treatments on respiratory failure or death due to RDS using Poisson distribution modeling, which accounts for the time over which the event could have occurred.
Incidence of Respiratory Failure or Death Due to RDS
Incidence of Respiratory Failure or Death due to RDS by Intubation or Failure Criteria
Number of Participants With Bronchopulmonary Dysplasia (BPD)
Summarizes the number of participants with BPD or alive without BPD

Full Information

First Posted
November 19, 2015
Last Updated
March 30, 2021
Sponsor
Windtree Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02636868
Brief Title
The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age
Official Title
A Multinational, Multicenter, Masked, Randomized, Controlled Study to Assess The Safety and Efficacy of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age With Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
August 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Windtree Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the safety and efficacy of lucinactant for inhalation administered as an aerosolized dose in two doses to preterm neonates 26 - 32 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for Respiratory Distress Syndrome (RDS) compared to neonates receiving nCPAP alone.
Detailed Description
The purpose of this study is to investigate the safety and efficacy of lucinactant for inhalation in preterm neonates 26 to 32 completed weeks post-menstrual age (PMA). Efficacy and safety are based on clinical evaluations. The endpoints specified are similar to those in Protocols 03-CL-1201 and 03-CL-1401 to allow for potential comparison and pooling of results. The objective of this study is to evaluate the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, compared to nCPAP alone, in preterm neonates with RDS, as assessed by the time to and incidence of respiratory failure and/or death due to RDS over the first 72 hours of life, the incidence of bronchopulmonary dysplasia (BPD) at 36 weeks PMA, and change in physiologic parameters (FiO2 and PCO2) over the first 72 hours of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerosolized lucinactant (low dose)
Arm Type
Experimental
Arm Description
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Arm Title
Aerosolized lucinactant (high dose)
Arm Type
Experimental
Arm Description
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Arm Title
nasal CPAP
Arm Type
Active Comparator
Arm Description
nCPAP alone
Intervention Type
Drug
Intervention Name(s)
Lucinactant delivered via investigational delivery device
Other Intervention Name(s)
AEROSURF
Intervention Description
Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
Intervention Type
Drug
Intervention Name(s)
nCPAP
Intervention Description
Nasal CPAP
Primary Outcome Measure Information:
Title
Number of Participants With Respiratory Failure or Death Due to Respiratory Distress Syndrome (RDS)
Description
Number of participants who had respiratory failure due to RDS or death due to RDS; known as nasal continuous positive airway pressure (nCPAP) failure
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Incidence of Respiratory Failure or Death Due to RDS
Description
Incidence of Respiratory Failure or Death Due to RDS by Intubation or Failure Criteria
Time Frame
72 hours
Title
Time to nCPAP Failure
Description
Time from birth to nCPAP Failure
Time Frame
72 hours
Title
Incidence of Respiratory Failure or Death Due to RDS With Poisson Distribution Modeling
Description
The measure tests the differences between treatments on respiratory failure or death due to RDS using Poisson distribution modeling, which accounts for the time over which the event could have occurred.
Time Frame
72 hours
Title
Incidence of Respiratory Failure or Death Due to RDS
Description
Incidence of Respiratory Failure or Death due to RDS by Intubation or Failure Criteria
Time Frame
28 days
Title
Number of Participants With Bronchopulmonary Dysplasia (BPD)
Description
Summarizes the number of participants with BPD or alive without BPD
Time Frame
36 weeks post-menstrual age (PMA)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
26 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent form (ICF) from legally authorized representative 26 0/7 to 32 6/7 completed weeks gestation PMA Successful implementation of non-invasive support or ventilation within 90 minutes after birth Spontaneous breathing Chest radiograph consistent with RDS Within the first 20 hours after birth requires an nCPAP of 5 to 7 centimeters water (cmH2O) with a fraction of inspired oxygen (FiO2) of ≥ 0.25 (>0.21 for neonates 26-28 weeks PMA) to 0.40 that is clinically indicated for at least 30 minutes to maintain oxygen by pulse oximetry (SpO2) of 90% to 95%. Transient (<10 minutes) FiO2 excursions outside this range do not reset the 30-minute requirement. Exclusion Criteria: A heart rate that cannot be stabilized above 100 beats per minute (bpm) within 5 minutes of birth Recurrent episodes of apnea requiring positive pressure ventilation (PPV) administered manually or mechanically through any patient interface A 5 minute Apgar score < 5 Major congenital malformation(s) or craniofacial abnormalities that preclude the use of nCPAP, diagnosed antenatally or immediately after birth Clinically significant diseases or conditions other than RDS which could potentially interfere with cardiopulmonary function (e.g. congenital heart disease, hydrops fetalis or congenital infection) A known or suspected chromosomal abnormality or syndrome Premature rupture of membranes (PROM) > 3 weeks Hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis A need for intubation and/or mechanical ventilation at any time before enrollment into the study The administration (or plan for administration) of any the following: Another investigational agent or investigational medical device Any other surfactant agent Systemic corticosteroids (other than antenatal steroids already received) Presence of air leak (pneumothorax, pneumomediastinum, pneumopericardium, subcutaneous emphysema, or definite evidence of pulmonary interstitial emphysema (PIE)) on the baseline chest radiograph
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Simonson, MD
Organizational Affiliation
Windtree Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Univ. of Arkansas Medical Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Sharp Mary Birch Hospital for Women and Newborns
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Christiana Care Health System
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
University of Miami Holtz Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Morgan Stanley Childrens Hospital of New York Presbyterian (CHONY)
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Brody School of Medicine at ECU
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
New Hanover Regional Medical Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Case Western Reserve University (Rainbow Babies Hosp.)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Women and Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Cook Children's Hospital
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Health Harris Methodist Hospital
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Montreal Children's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
Facility Name
Sainte Justine Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Hospital Dr Sotero Del Rio
City
Santiago
State/Province
Region-MetropolitanadeSantiago
ZIP/Postal Code
8207257
Country
Chile
Facility Name
Hospital Clínico Regional de Concepción Dr Guillermo Grant Benavente
City
Concepción
ZIP/Postal Code
4070038
Country
Chile
Facility Name
Hospital San Jose
City
Santiago
ZIP/Postal Code
3330
Country
Chile
Facility Name
Clinica Alamena de Santiago
City
Santiago
ZIP/Postal Code
7650568
Country
Chile
Facility Name
Hospital Santiago Oriente Dr Luis Tisné Brousse
City
Santiago
ZIP/Postal Code
7980378
Country
Chile
Facility Name
Hospital Clinico de la Pontificia Universidad Catolica de Chile
City
Santiago
ZIP/Postal Code
8330024
Country
Chile
Facility Name
Hospital San Juan de Dios
City
Santiago
ZIP/Postal Code
8350488
Country
Chile
Facility Name
Fundacion Hospitalaria San Vicente de Paul
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050010
Country
Colombia
Facility Name
Hospital General de Medellin
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050015
Country
Colombia
Facility Name
Fundacion Valle Del Lili
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760032
Country
Colombia
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Facility Name
Csolnoky Ferenc Korhaz
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
H-4012
Country
Hungary
Facility Name
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Okato
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
City
Nyiregyhaza
ZIP/Postal Code
H-4400
Country
Hungary
Facility Name
Cork University Hospital
City
Cork
ZIP/Postal Code
T12 YN60
Country
Ireland
Facility Name
Mid-Western Regional Hospital Limerick
City
Limerick
Country
Ireland
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3000 CB
Country
Netherlands
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-556
Country
Poland
Facility Name
S.U. nr2im. Dr. Jana Biziela Oddzial Kliniczny N. W. Z. Intensywna Terapia Noworodka wraz z Wgjazdowy m Zespolem N
City
Bydgoszcz
State/Province
Kujawsko-pomorksie
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Instytut Centrum Zdrowja Matki Polki Klinika Neonatologii
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
93-338
Country
Poland
Facility Name
SP ZOZ Szpital Uniwersytecki w Krakowie, Oddzial Neonatologii
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Szpital Kliniczny im. Ks, Anny Mazowieckiej Klinika Neonatologii
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
00-315
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-402
Country
Poland
Facility Name
Szpital Spegialistycszny nr 2 w Bytomia Oddzial Noworodkow Blok V
City
Bytom
State/Province
Slaskie
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Samodzielny Publiczny Specjalistczny Zaklad Opieki Zdrowotnej Zdroje
City
Szczecin
State/Province
West Pomerania
ZIP/Postal Code
70-780
Country
Poland
Facility Name
Ginekologiczno-Polozniczy Szpital Klinicznym UM im. Karola Marcinkowskiego w Poznan i u Katedra Neonatologii
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-535
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age

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