Phase 2 N=221 Randomized Triple-blind Treatment

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

Respiratory Distress Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT02636868 ↗

Enrolled (actual)

221

Serious AEs

23.5%

Results posted

Apr 2021

Primary outcome: Primary: Number of Participants With Respiratory Failure or Death Due to Respiratory Distress Syndrome (RDS) — 31; 32; 31 Participants — p=0.363

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Lucinactant delivered via investigational delivery device (Drug); nCPAP (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Windtree Therapeutics
Primary completion: Jul 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Respiratory Failure or Death Due to Respiratory Distress Syndrome (RDS)	31; 32; 31	0.363
SECONDARY Incidence of Respiratory Failure or Death Due to RDS	35; 32; 31	0.099
SECONDARY Time to nCPAP Failure	39.3; 44.8; 40.7	0.996
SECONDARY Incidence of Respiratory Failure or Death Due to RDS With Poisson Distribution Modeling	31; 32; 31	0.312
SECONDARY Incidence of Respiratory Failure or Death Due to RDS	35; 32; 31	0.099
SECONDARY Number of Participants With Bronchopulmonary Dysplasia (BPD)	7; 7; 10; 62; 64; 59	0.534

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.

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 ( 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02636868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.