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

Aerogen

Status and phase: Completed; Phase 2

Conditions: Respiratory Distress Syndrome in Premature Infant

Treatments: Other: nCPAP; Drug: AeroFact

Study type: Interventional

Funder types: Industry

Identifiers

NCT03969992

APC-AF-CLN-002

Details and patient eligibility

About

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.

Full 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)

Enrollment: 261 patients

Sex: All

Ages: 26 to 31 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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261 participants in 3 patient groups

nCPAP alone

Other group

Description:

Standard of Care (nasal continuous positive airway pressure-nCPAP) with instilled bolus surfactant when medically necessary

Treatment:

Other: nCPAP

Drug: Low Dose AeroFact

Experimental group

Description:

AeroFact-low dose SF-RI 1

Treatment:

Drug: AeroFact

Drug: High Dose AeroFact

Experimental group

Description:

AeroFact-high dose SF-RI 1

Treatment:

Drug: AeroFact