NCT03969992

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

A Partially Blinded, Randomized, Controlled, Parallel-Group, Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact in Preterm Infants at Risk of Worsening Respiratory Distress Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: Aerogen Pharma Limited · Industry
• Sex: All
• Age: 26 Weeks – 31 Weeks
• Healthy volunteers: Not accepted

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.

Detailed description

Part I Primary Objective To determine an optimal dose of AeroFact administered by nasal continuous positive airway pressure (nCPAP) versus stand of care in reducing the rate of intubation/cannulation and bolus surfactant instillation in the first 7 days after birth. Part II Primary Objective To evaluate pulmonary outcomes and respiratory utilization at 3, 6, 9, and 12 months post-menstrual age (PMA)

Conditions

• Respiratory Distress Syndrome in Premature Infant

Interventions

Type	Name	Description
DRUG	AeroFact	Aerosolized SF-RI 1
OTHER	nCPAP	nCPAP (nasal continuous positive airway pressure) alone

Timeline

• Start date: 2020-03-04
• Primary completion: 2023-08-04
• Completion: 2024-08-05
• First posted: 2019-05-31
• Last updated: 2025-08-07
• Results posted: 2025-08-07

Locations

41 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study