drugset / Trial / NCT02636868

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

NCT02636868

Phase 2 Completed 221 enrolled Windtree Therapeutics
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2015-12
Primary completion
2017-07
Completion
2019-08-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Lucinactant Peptide Other