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

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.

Timeline

Start

2020-03-04

Primary completion

2023-08-04

Completion

2024-08-05

Outcome

Missed primary endpoint

registry analysis (superiority test); Control: nCPAP Alone vs Drug: Low Dose AeroFact vs Drug: High Dose AeroFact; p = 0.1924 NCT03969992 ↗

Drugs

Indications