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NCT02528318 · ClinicalTrials.gov registry record · Phase 2

Trial To Assess The Safety And Tolerability Of Lucinactant For Inhalation In Preterm Neonates 26 to 28 Weeks PMA

A Phase 2 study, sponsored by Windtree Therapeutics.

Terminated
Registry status
Phase 2
Development phase
48
Enrollment target

NCT02528318: Clinical Trial Phase 2 study, sponsored by Windtree Therapeutics.

NCT02528318 is a Phase 2 study that was terminated before completion, run by Windtree Therapeutics. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02528318, a Phase 2 study, was terminated before completion, sponsored by Windtree Therapeutics.

TERMINATED
Registry status
Phase 2
Development phase
48 participants
Enrollment target

Study Summary

This study is to evaluate the safety and tolerability of lucinactant for inhalation, administered as an aerosol in up to four escalating doses to preterm neonates 26 to 28 weeks gestational age who are receiving nCPAP for RDS compared to neonates receiving nCPAP alone.

Primary Outcome

Number of Participants with adverse events that were experienced during the initial study treatment

Interventions

  • DEVICE nCPAP alone
  • COMBINATION_PRODUCT Lucinactant for inhalation

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2015-08
Est. Completion 2017-08-11
Phase Phase 2
Windtree Therapeutics

11 total trials

Why NCT02528318 stopped before completion

NCT02528318 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).

The record links to 0 conditions, and to 2 interventions - of which nCPAP alone is the first listed.

NCT02528318 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02528318 about?

NCT02528318 is a clinical study titled "Trial To Assess The Safety And Tolerability Of Lucinactant For Inhalation In Preterm Neonates 26 to 28 Weeks PMA". This study is to evaluate the safety and tolerability of lucinactant for inhalation, administered as an aerosol in up to four escalating doses to preterm neonates 26 to 28 weeks gestational age who are receiving nCPAP for RDS compared to neonates receiving nCPAP alone.

What is the current status of trial NCT02528318?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2015-08. Estimated completion is 2017-08-11.

What interventions are being tested in trial NCT02528318?

The interventions under investigation include: nCPAP alone (DEVICE), Lucinactant for inhalation (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT02528318?

This trial is sponsored by Windtree Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02528318's enrollment target sits among peer trials

48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02528318, the US trial registry maintained by the National Library of Medicine. NCT02528318 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.