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

Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02636868
• Other study ID #: 03-CL-1202
• Status: Completed
• Phase: Phase 2
• Start date: December 2015
• Est. completion date: August 6, 2019

Study information

• Verified date: March 2021
• Source: Windtree Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: August 6, 2019
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Weeks to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Drug:
• Lucinactant delivered via investigational delivery device
Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
• nCPAP
Nasal CPAP

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	Montreal Children's Hospital	Montreal	Quebec
Canada	Sainte Justine Hospital	Montreal	Quebec
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Chile	Hospital Clínico Regional de Concepción Dr Guillermo Grant Benavente	Concepción
Chile	Clinica Alamena de Santiago	Santiago
Chile	Hospital Clinico de la Pontificia Universidad Catolica de Chile	Santiago
Chile	Hospital Dr Sotero Del Rio	Santiago	Region-MetropolitanadeSantiago
Chile	Hospital San Jose	Santiago
Chile	Hospital San Juan de Dios	Santiago
Chile	Hospital Santiago Oriente Dr Luis Tisné Brousse	Santiago
Colombia	Fundacion Valle Del Lili	Cali	Valle Del Cauca
Colombia	Fundacion Hospitalaria San Vicente de Paul	Medellin	Antioquia
Colombia	Hospital General de Medellin	Medellin	Antioquia
Hungary	Semmelweis Egyetem	Budapest
Hungary	Csolnoky Ferenc Korhaz	Debrecen
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Okato	Miskolc
Hungary	Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz	Nyiregyhaza
Ireland	Cork University Hospital	Cork
Ireland	Mid-Western Regional Hospital Limerick	Limerick
Netherlands	Erasmus Medical Center	Rotterdam
Poland	S.U. nr2im. Dr. Jana Biziela Oddzial Kliniczny N. W. Z. Intensywna Terapia Noworodka wraz z Wgjazdowy m Zespolem N	Bydgoszcz	Kujawsko-pomorksie
Poland	Szpital Spegialistycszny nr 2 w Bytomia Oddzial Noworodkow Blok V	Bytom	Slaskie
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk	Pomorskie
Poland	SP ZOZ Szpital Uniwersytecki w Krakowie, Oddzial Neonatologii	Krakow	Malopolskie
Poland	Instytut Centrum Zdrowja Matki Polki Klinika Neonatologii	Lodz	Lodzkie
Poland	Ginekologiczno-Polozniczy Szpital Klinicznym UM im. Karola Marcinkowskiego w Poznan i u Katedra Neonatologii	Poznan	Wielkopolskie
Poland	Samodzielny Publiczny Specjalistczny Zaklad Opieki Zdrowotnej Zdroje	Szczecin	West Pomerania
Poland	Szpital Kliniczny im. Ks, Anny Mazowieckiej Klinika Neonatologii	Warsaw	Mazowieckie
Poland	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu	Wroclaw	Dolnoslaskie
United States	Albany Medical Center	Albany	New York
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Case Western Reserve University (Rainbow Babies Hosp.)	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Cook Children's Hospital	Fort Worth	Texas
United States	Texas Health Harris Methodist Hospital	Fort Worth	Texas
United States	Brody School of Medicine at ECU	Greenville	North Carolina
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Univ. of Arkansas Medical Center	Little Rock	Arkansas
United States	Loma Linda University Medical Center	Loma Linda	California
United States	University of Miami Holtz Children's Hospital	Miami	Florida
United States	Morgan Stanley Childrens Hospital of New York Presbyterian (CHONY)	New York	New York
United States	Christiana Care Health System	Newark	Delaware
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Children's Hospital of Orange County	Orange	California
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Women and Infants Hospital	Providence	Rhode Island
United States	Sharp Mary Birch Hospital for Women and Newborns	San Diego	California
United States	New Hanover Regional Medical Center	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Windtree Therapeutics

Countries where clinical trial is conducted

United States,  Canada,  Chile,  Colombia,  Hungary,  Ireland,  Netherlands,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	72 hours
Secondary	Incidence of Respiratory Failure or Death Due to RDS	Incidence of Respiratory Failure or Death Due to RDS by Intubation or Failure Criteria	72 hours
Secondary	Time to nCPAP Failure	Time from birth to nCPAP Failure	72 hours
Secondary	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.	72 hours
Secondary	Incidence of Respiratory Failure or Death Due to RDS	Incidence of Respiratory Failure or Death due to RDS by Intubation or Failure Criteria	28 days
Secondary	Number of Participants With Bronchopulmonary Dysplasia (BPD)	Summarizes the number of participants with BPD or alive without BPD	36 weeks post-menstrual age (PMA)