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NCT03969992 · ClinicalTrials.gov registry record · Phase 2

A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact

A Phase 2 study, sponsored by Aerogen Pharma Limited.

Completed
Registry status
Phase 2
Development phase
261
Enrollment target

NCT03969992: Completed Phase 2 study, sponsored by Aerogen Pharma Limited.

NCT03969992 is a Phase 2 study that has completed, run by Aerogen Pharma Limited. The registered enrollment target is 261 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03969992, a Phase 2 study, has completed, sponsored by Aerogen Pharma Limited.

COMPLETED
Registry status
Phase 2
Development phase
261 participants
Enrollment target

Study Summary

The purpose of this two-part Phase 2 study is to assess the safety, tolerability and efficacy of aerosolized SF-RI 1 (AeroFact) when delivered via nCPAP at two different doses.

Primary Outcome

Number of patients who require intubation/cannulation with bolus surfactant instillation

Interventions

  • DRUG AeroFact
  • OTHER nCPAP

Trial Details

FieldValue
Enrollment Target 261 participants
Start Date 2020-03-04
Est. Completion 2024-08-05
Phase Phase 2
Aerogen Pharma Limited

4 total trials

What the finished NCT03969992 record still lists

NCT03969992 is an interventional study that assigns participants to a tested intervention. The registered 261 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% higher).

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

NCT03969992 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03969992 about?

NCT03969992 is a clinical study titled "A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact". The purpose of this two-part Phase 2 study is to assess the safety, tolerability and efficacy of aerosolized SF-RI 1 (AeroFact) when delivered via nCPAP at two different doses.

What is the current status of trial NCT03969992?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 261 participants. The study started on 2020-03-04. Estimated completion is 2024-08-05.

What interventions are being tested in trial NCT03969992?

The interventions under investigation include: AeroFact (DRUG), nCPAP (OTHER).

Who is sponsoring clinical trial NCT03969992?

This trial is sponsored by Aerogen Pharma Limited, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03969992's enrollment target sits among peer trials

261 210th of 2000 higher than 1,791 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 NCT03969992, the US trial registry maintained by the National Library of Medicine. NCT03969992 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.