CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 221 enrolled
Drug / intervention
Lucinactant delivered via investigational delivery device +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02636868
NCT02636868Phase 2Completed
CompareCT.gov

A Multinational, Multicenter, Masked, Randomized, Controlled Study to Assess The Safety and Efficacy of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age With Respiratory Distress Syndrome

Windtree Therapeutics·interventional·Posted Dec 22, 2015·Updated Apr 23, 2021

In Brief

A Phase 2 clinical trial evaluating Lucinactant delivered via investigational delivery device and nCPAP for Respiratory Distress Syndrome. Completed, enrolled 221 participants across 54 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Distress Syndrome
CountriesCanada, Chile, Colombia, Hungary, Ireland, Netherlands, Poland, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 22, 2015
Enrollment StartDec 1, 2015
Primary CompletionJul 1, 2017
Study CompletionAug 6, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.5 years ago

Interventions

Lucinactant delivered via investigational delivery devicedrug

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

nCPAPdrug

Nasal CPAP