A Randomized, Controlled, Blinded, Parallel Group Study of the Safety and Efficacy of APC-0101 (SF-RI 1 Surfactant for Inhalation Combined With a Dedicated Delivery System) in Preterm Infants With Respiratory Distress Syndrome

Aerogen Pharma Limited12 sites in 1 country520 target enrollmentSeptember 24, 2025

InterventionsControl APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system)

Overview

Phase: Phase 3
Intervention: Control
Conditions: Not specified
Sponsor: Aerogen Pharma Limited
Enrollment: 520
Locations: 12
Primary Endpoint: Failure Criteria
Status: Recruiting
Last Updated: 18 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a 2-part, prospective, randomized, blinded, sham-controlled, multi-center study comparing preterm subjects with RDS who are treated with APC-0101 and nCPAP/NIV to subjects treated with nCPAP/NIV alone (Sham). In Part 1, subjects will be followed until they reach 40 weeks post-menstrual age (PMA) or are discharged from the NICU, whichever comes first. In Part 2, subjects will undergo post-term follow-up through 24 months corrected age.

Registry

clinicaltrials.gov

Start Date

September 24, 2025

End Date

May 1, 2029

Last Updated

18 days ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Aerogen Pharma Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Inborn at the study site's hospital (i.e., not transferred from another hospital following delivery)
•Gestational age at birth of 26 through 33 weeks PMA
•Birth weight appropriate for gestational age (AGA, weight 3rd to 97th percentile on Fenton Growth Curve)
•Birth weight ≤ 2000 grams
•Post-natal age 1 to 24 hours at randomization
•On nCPAP or NIV for at least 30 minutes with RSS = 1.4 - 2.0 to maintain SpO2 90-95% at randomization. RSS is calculated as (nCPAP cm H2O) × (FiO2) or as (NIV mean airway pressure cm H2O) × (FiO2).
•FiO2 ≥ 0.24 at randomization
•nCPAP or mPaw ≥ 6 cm H2O at randomization
•Chest radiograph (CXR) or lung ultrasound compatible with RDS prior to randomization

Exclusion Criteria

•On SiPAP®, RAM® cannula, or high flow nasal cannula (HFNC) (\> 2 liters per minute \[LPM\]) at the time of randomization
•Prior instillation of surfactant
•Premature rupture of membranes (PROM) occurring \> 14 days before birth
•Significant congenital/chromosomal anomaly (e.g., Pierre Robin syndrome, clinically significant congenital heart disease, or trisomy)
•Pneumothorax
•Other etiologies of respiratory distress
•Enrollment in another interventional study with similar efficacy endpoints
•Apgar score at 5 min of 0-3
•Prior cardiopulmonary resuscitation (CPR) or epinephrine
•Base Deficit \> 15 mEq/L on most recent arterial blood gas (not capillary blood gas, venous blood gas, or cord gas) prior to randomization. Note that arterial blood gas is not required prior to randomization.