A Phase 2 interventional study of Lucinactant for Inhalation and nCPAP Only in Respiratory Distress Syndrome, Newborn, sponsored by Windtree Therapeutics. Terminated at 3 sites in Poland. Open to participants aged 30 Minutes to 6 Hours. Per ClinicalTrials.gov, last updated 2023-05-24.
Sponsored by Windtree Therapeutics · Phase 2, Interventional, and Treatment
This study is to evaluate the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, in comparison to nCPAP alone, in preterm neonates with RDS, as assessed by the incidence of and time to respiratory failure and/or death due to RDS in the first 72 hours and 28 days of life. Half of the subjects will receive lucinactant for inhalation and half will receive standard of care (nCPAP alone).
An unmet medical need exists for a means to deliver surfactant replacement therapy (SRT) to preterm neonates with RDS supported with nCPAP early in the course of the disease. This strategy has the potential to improve RDS prior to the development of respiratory failure, thereby avoiding the need for endotracheal intubation and mechanical ventilation (MV), or reduce the duration of MV, and the resultant potential for morbidity and complications. The ability to administer SRT via aerosol has the potential to address this unmet need.
Lucinactant for inhalation (AEROSURF) is an investigational drug-device combination product, designed to deliver aerosolized SRT to preterm neonates with RDS who are being supported with nCPAP. The drug component of lucinactant for inhalation is lyophilized lucinactant, a lyophilized form of SURFAXIN® (lucinactant) Intratracheal Suspension. The device component, the AEROSURF Delivery System (ADS), the next-generation device following use of the prototype device in earlier trials, uses novel technology to aerosolize lucinactant for inhalation.
This study evaluates the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, in comparison to nCPAP alone, in preterm neonates with RDS, as assessed by pre-specified outcome measures. In addition, this study will evaluate the device and the ability to administer up to 3 repeat doses.
1,179 studies on the registry are indexed under Respiratory Distress Syndrome, Newborn; 160 are open to participants now.
This study's enrollment of 12 is below the median of 60 across 714 interventional studies indexed under Respiratory Distress Syndrome, Newborn.
Browse Respiratory Distress Syndrome, Newborn studies →Windtree Therapeutics is the lead sponsor of 14 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Lucinactant for inhalation, 160 mg total phospholipids (TPL)/kg Delivered as an aerosol once, with up to 3 repeats of 80 mg/kg allowed within 36 hours of birth
Combination Product: Lucinactant for Inhalation
nCPAP Only as sham comparator. Bubble nCPAP is standard of care. Treatment time behind barrier to match active treatment delivery time
Other: nCPAP Only
A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nasal continuous positive airway pressure (nCPAP).
Also known as: AEROSURF
Nasal continuous positive airway pressure (nCPAP) alone
Number of Participants With Respiratory Failure or Death
Number of participants with respiratory failure due to RDS or death. Respiratory failure due to RDS is defined as intubation for mechanical ventilation and/or surfactant administration
Time frame: 28 days of life
Number With BPD
Number of participants with bronchopulmonary dysplasia (BPD)
Time frame: 36 weeks post-menstrual age (PMA)
Mortality
All-cause mortality
Time frame: 36 weeks PMA or 28 days of life (whichever is later)
Number of Participants With Common Complications of Prematurity
Number of participants with complications including intraventricular hemorrhage, periventricular leukomalacia, pulmonary hemorrhage, apnea, necrotizing enterocolitis, patent ductus arteriosus, acquired sepsis, and retinopathy of prematurity.
Time frame: 36 weeks PMA
Enrollment period: 18 April 2020 to 19 January 2021 Enrollment occurred in neonatal intensive care units.
| Milestone | Lucinactant (160 mg/kg) + nCPAP | nCPAP Only |
|---|---|---|
| Started | 11 | 1 |
| Completed | 11 | 1 |
| Not completed | 0 | 0 |
Number of participants with respiratory failure due to RDS or death. Respiratory failure due to RDS is defined as intubation for mechanical ventilation and/or surfactant administration
| Participants | Lucinactant (160 mg/kg) + nCPAP | nCPAP Only |
|---|---|---|
| Number of Participants With Respiratory Failure or Death | 6 | 0 |
Number of participants with bronchopulmonary dysplasia (BPD)
| Participants | Lucinactant (160 mg/kg) + nCPAP | nCPAP Only |
|---|---|---|
| Number With BPD | 0 | 0 |
All-cause mortality
| Participants | Lucinactant (160 mg/kg) + nCPAP | nCPAP Only |
|---|---|---|
| Mortality | 0 | 0 |
Number of participants with complications including intraventricular hemorrhage, periventricular leukomalacia, pulmonary hemorrhage, apnea, necrotizing enterocolitis, patent ductus arteriosus, acquired sepsis, and retinopathy of prematurity.
| Participants | Lucinactant (160 mg/kg) + nCPAP | nCPAP Only |
|---|---|---|
| Number of Participants With Common Complications of Prematurity | 9 | 1 |
Collected over Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lucinactant (160 mg/kg) + nCPAP | 0/11 (0%) | 2/11 (18.2%) | 11/11 (100%) |
| nCPAP Only | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | Lucinactant (160 mg/kg) + nCPAP | nCPAP Only |
|---|---|---|
| Duodenal atresiaCongenital, familial and genetic disorders | 1/11 | 0/1 |
| PneumonediastinumRespiratory, thoracic and mediastinal disorders | 1/11 | 0/1 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 1/11 | 0/1 |
| Event | Lucinactant (160 mg/kg) + nCPAP | nCPAP Only |
|---|---|---|
| RegurgitationGastrointestinal disorders | 1/11 | 1/1 |
| Sepsis neonatalInfections and infestations | 3/11 | 1/1 |
| Oxygen saturation decreasedInvestigations | 7/11 | 1/1 |
| Feeding intoleranceMetabolism and nutrition disorders | 4/11 | 1/1 |
| Agitation neonatalPregnancy, puerperium and perinatal conditions | 5/11 | 1/1 |
| OliguriaRenal and urinary disorders | 0/11 | 1/1 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/11 | 1/1 |
| Nasal inflammationRespiratory, thoracic and mediastinal disorders | 1/11 | 1/1 |
| Anemia neonatalBlood and lymphatic system disorders | 8/11 | 0/1 |
| Infantile apnoeaRespiratory, thoracic and mediastinal disorders | 8/11 | 0/1 |
Intent-to-Treat
| Age, Continuous(hours) | Lucinactant (160 mg/kg) + nCPAP | nCPAP Only | Total |
|---|---|---|---|
| Median | 3.25 (1.05 to 4.85) | 1.05 (1.05 to 1.05) | 3.02 (1.05 to 4.85) |
| Age, Customized(weeks) | Lucinactant (160 mg/kg) + nCPAP | nCPAP Only | Total |
|---|---|---|---|
| Gestational Age | 30.3 (28.4 to 32.6) | 31.0 (31 to 31) | 30.4 (29.1 to 31.9) |
| Sex: Female, Male(Participants) | Lucinactant (160 mg/kg) + nCPAP | nCPAP Only | Total |
|---|---|---|---|
| Female | 4 | 1 | 5 |
| Male | 7 | 0 | 7 |
| Ethnicity (NIH/OMB)(Participants) | Lucinactant (160 mg/kg) + nCPAP | nCPAP Only | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 11 | 1 | 12 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Lucinactant (160 mg/kg) + nCPAP | nCPAP Only | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 11 | 1 | 12 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Lucinactant (160 mg/kg) + nCPAP | nCPAP Only | Total |
|---|---|---|---|
| Poland | 11 | 1 | 12 |
| Apgar Score at One Minute(Scores on a scale) | Lucinactant (160 mg/kg) + nCPAP | nCPAP Only | Total |
|---|---|---|---|
| Median | 7.0 (4 to 9) | 7.0 (7 to 7) | 7.0 (4 to 9) |
| Apgar Score at Five Minutes(Scores on a scale) | Lucinactant (160 mg/kg) + nCPAP | nCPAP Only | Total |
|---|---|---|---|
| Median | 8.0 (7 to 8) | 8.0 (8 to 8) | 8.0 (7 to 8) |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Apr 2020 to primary completion in Jan 2021, 9 months.
Results were first posted in May 2023, 2 years 3 months after primary completion.
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Respiratory Distress Syndrome, Newborn →
Windtree Therapeutics