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

NCT03969992 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2025-08-07

Study results available
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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.

Conditions

  • Respiratory Distress Syndrome in Premature Infant

Interventions

DRUG

AeroFact

Aerosolized SF-RI 1

OTHER

nCPAP

nCPAP (nasal continuous positive airway pressure) alone

Sponsors & Collaborators

  • Aerogen Pharma Limited

    lead INDUSTRY

Principal Investigators

  • David Durand, MD · Aerogen Pharma Corp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
26 Weeks
Max Age
31 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-04
Primary Completion
2023-08-04
Completion
2024-08-05
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03969992 on ClinicalTrials.gov