Phase 2
N=261
A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact
Respiratory Distress Syndrome in Premature Infant
Bottom Line
View on ClinicalTrials.gov: NCT03969992 ↗Enrolled (actual)
261
Serious AEs
8.1%
Results posted
Aug 2025
Primary outcome: Primary: Intubation/Cannulation and Instilled Surfactant — 45; 21; 26 Participants — p=0.1924
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AeroFact (Drug); nCPAP (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Aerogen Pharma Limited
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intubation/Cannulation and Instilled Surfactant |
45; 21; 26 | 0.1924 |
| SECONDARY Time to First Intubation/Cannulation and Bolus Surfactant Instillation |
17.5; 13.6; 22.4 | — |
| SECONDARY Proportion of Infants Who Received Multiple Doses of Bolus Surfactant |
7; 1; 5 | — |
| SECONDARY Number of Days on Invasive Mechanical Ventilation |
4.8; 6.0; 4.0 | — |
| SECONDARY Proportion of Patients Survived Without Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post-menstrual Age (PMA) |
69; 55; 53 | — |
| SECONDARY Proportion of Patients Survived Without Bronchopulmonary Dysplasia (BPD) at 40 Weeks Post-menstrual Age (PMA) |
74; 58; 56 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Parental consent obtained prior to study procedures being performed (pre-natal consent is allowed)
- 26 0/7 to 30 6/7 weeks of gestational age
- Weight 14 days
- Need for intubation and/or mechanical ventilation prior to enrollment
- Active pneumothorax requiring chest tube
- Significant congenital anomaly, chromosomal abnormality
- Concomitant treatments with inhaled nitric oxide
Data sourced from ClinicalTrials.gov (NCT03969992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.