NCT02074059

Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates

A Multicenter, Randomized, Open-Label, Controlled Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Preterm Neonates 29 to 34 Weeks PMA: Dose Escalation and Study Extension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Windtree Therapeutics · Industry
• Sex: All
• Age: 29 Weeks – 34 Weeks
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and tolerability of aerosolized surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses to preterm neonates 29 to 34 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS), compared to neonates receiving nCPAP alone.

Conditions

• Respiratory Distress Syndrome

Interventions

Type	Name	Description
DRUG	Lucinactant for Inhalation	Lucinactant for Inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
DEVICE	nCPAP alone	nCPAP therapy

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-10-01
• Completion: 2015-11-01
• First posted: 2014-02-28
• Last updated: 2017-04-21
• Results posted: 2017-04-21

Locations

11 sites across 1 country: United States