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

NCT ID: NCT02636868

Last Updated: 2021-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2019-08-06

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.

Conditions

Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Aerosolized lucinactant (low dose)

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

Group Type: EXPERIMENTAL

Lucinactant delivered via investigational delivery device

Intervention Type: DRUG

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

nCPAP

Intervention Type: DRUG

Nasal CPAP

Aerosolized lucinactant (high dose)

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

Group Type: EXPERIMENTAL

Lucinactant delivered via investigational delivery device

Intervention Type: DRUG

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

nCPAP

Intervention Type: DRUG

Nasal CPAP

nasal CPAP

nCPAP alone

Group Type: ACTIVE_COMPARATOR

nCPAP

Intervention Type: DRUG

Nasal CPAP

Interventions

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)

Intervention Type: DRUG

nCPAP

Nasal CPAP

Intervention Type: DRUG

Other Intervention Names

AEROSURF

Eligibility Criteria

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

• Minimum Eligible Age: 26 Weeks
• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Windtree Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Simonson, MD

Role: STUDY_DIRECTOR

Windtree Therapeutics

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Univ. of Arkansas Medical Center

Little Rock, Arkansas, United States

Loma Linda University Medical Center

Loma Linda, California, United States

Children's Hospital of Orange County

Orange, California, United States

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, United States

Christiana Care Health System

Newark, Delaware, United States

University of Miami Holtz Children's Hospital

Miami, Florida, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Albany Medical Center

Albany, New York, United States

Morgan Stanley Childrens Hospital of New York Presbyterian (CHONY)

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Brody School of Medicine at ECU

Greenville, North Carolina, United States

New Hanover Regional Medical Center

Wilmington, North Carolina, United States

Case Western Reserve University (Rainbow Babies Hosp.)

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Providence St. Vincent Medical Center

Portland, Oregon, United States

Women and Infants Hospital

Providence, Rhode Island, United States

Baylor University Medical Center

Dallas, Texas, United States

Cook Children's Hospital

Fort Worth, Texas, United States

Texas Health Harris Methodist Hospital

Fort Worth, Texas, United States

Foothills Medical Centre

Calgary, Alberta, Canada

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Montreal Children's Hospital

Montreal, Quebec, Canada

Sainte Justine Hospital

Montreal, Quebec, Canada

Hospital Dr Sotero Del Rio

Santiago, Region-MetropolitanadeSantiago, Chile

Hospital Clínico Regional de Concepción Dr Guillermo Grant Benavente

Concepción, , Chile

Hospital San Jose

Santiago, , Chile

Clinica Alamena de Santiago

Santiago, , Chile

Hospital Santiago Oriente Dr Luis Tisné Brousse

Santiago, , Chile

Hospital Clinico de la Pontificia Universidad Catolica de Chile

Santiago, , Chile

Hospital San Juan de Dios

Santiago, , Chile

Fundacion Hospitalaria San Vicente de Paul

Medellín, Antioquia, Colombia

Hospital General de Medellin

Medellín, Antioquia, Colombia

Fundacion Valle Del Lili

Cali, Valle del Cauca Department, Colombia

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

Nyíregyháza, , Hungary

Cork University Hospital

Cork, , Ireland

Mid-Western Regional Hospital Limerick

Limerick, , Ireland

Erasmus Medical Center

Rotterdam, , Netherlands

Ginekologiczno-Polozniczy Szpital Klinicznym UM im. Karola Marcinkowskiego w Poznan i u Katedra Neonatologii

Poznan, Greater Poland Voivodeship, 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

SP ZOZ Szpital Uniwersytecki w Krakowie, Oddzial Neonatologii

Krakow, Lesser Poland Voivodeship, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, Lower Silesian Voivodeship, Poland

Szpital Kliniczny im. Ks, Anny Mazowieckiej Klinika Neonatologii

Warsaw, Masovian Voivodeship, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship, Poland

Szpital Spegialistycszny nr 2 w Bytomia Oddzial Noworodkow Blok V

Bytom, Silesian Voivodeship, Poland

Samodzielny Publiczny Specjalistczny Zaklad Opieki Zdrowotnej Zdroje

Szczecin, West Pomeranian Voivodeship, Poland

Instytut Centrum Zdrowja Matki Polki Klinika Neonatologii

Lodz, Łódź Voivodeship, Poland

Countries

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

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

03-CL-1202

Identifier Type: -

Identifier Source: org_study_id