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

Phase 2

Completed

• Conditions: Respiratory Distress Syndrome in Premature Infant
• Interventions: Other: nCPAP; Drug: AeroFact

• Registration Number: NCT03969992
• Lead Sponsor: Aerogen Pharma Limited

Brief 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)

Study Timeline

• Study First Submitted: 2019-04-05
• Study First Submitted QC: 2019-05-30
• Study First Posted: 2019-05-31
• Study Start: 2020-03-04
• Primary Completion: 2023-08-04
• Status Verified: 2024-08
• Study Completion: 2024-08-05
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

Inclusion Criteria

1. Parental consent obtained prior to study procedures being performed (pre-natal consent is allowed)
2. 26 0/7 to 30 6/7 weeks of gestational age
3. Weight <2.0 Kg
4. Respiratory Severity Score (RSS) 1.4-2.0

Exclusion Criteria

1. Apgar score less than or equal to 5 at five minutes after birth
2. Need for chest compressions or administration of epinephrine or bicarbonate in the delivery room
3. Premature rupture of membranes (PROM) > 14 days
4. Need for intubation and/or mechanical ventilation prior to enrollment
5. Active pneumothorax requiring chest tube
6. Significant congenital anomaly, chromosomal abnormality
7. Concomitant treatments with inhaled nitric oxide

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nCPAP alone	nCPAP	Standard of Care (nasal continuous positive airway pressure-nCPAP) with instilled bolus surfactant when medically necessary
Drug: High Dose AeroFact	AeroFact	AeroFact-high dose SF-RI 1
Drug: Low Dose AeroFact	AeroFact	AeroFact-low dose SF-RI 1

Primary Outcome Measures

Name	Time	Method
Percent of patients with respiratory symptoms requiring intervention across groups	12 months	Comparison of respiratory symptoms (Asthma/URI) and respiratory medications between groups
Percent of patients requiring supplemental oxygen and visits for medical care (Doctor's office/ER/Hospitalization)	12 months	Assess need for supplemental oxygen and other respiratory support and visits to physician office/ER/hospitalizations between groups
Incidence of intubation/cannulation and instilled surfactant	7 days	Number of patients who require intubation/cannulation with bolus surfactant instillation

Secondary Outcome Measures

Name	Time	Method
Percent of patients requiring repeat surfactant dosing between groups	7 days	Assess the need for more than one dose of surfactant between groups

Trial Locations

Locations (35)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Alta Bates Summit; 🇺🇸 Berkeley, California, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

University of Florida Health; 🇺🇸 Jacksonville, Florida, United States

Wolfson Children's Hospital; 🇺🇸 Jacksonville, Florida, United States

Advent Health; 🇺🇸 Orlando, Florida, United States

Northside Hospital Atlanta; 🇺🇸 Atlanta, Georgia, United States

University of Illinois; 🇺🇸 Chicago, Illinois, United States

Hospital of South Bend; 🇺🇸 South Bend, Indiana, United States

University of Kentucky; 🇺🇸 Louisville, Kentucky, United States

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