At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 261 enrolled
Drug / intervention
AeroFact +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating AeroFact and nCPAP for Respiratory Distress Syndrome in Premature Infant. Completed, enrolled 261 participants across 41 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedMay 2019
Enrollment StartMar 2020
Primary CompletionAug 2023
Study CompletionAug 2024
TodayJul 2026
First PostedMay 31, 2019
Enrollment StartMar 4, 2020
Primary CompletionAug 4, 2023
Study CompletionAug 5, 2024
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 7.1 years ago
Interventions
AeroFactdrug
Aerosolized SF-RI 1
nCPAPother
nCPAP (nasal continuous positive airway pressure) alone