Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates

Windtree Therapeutics

Status and phase: Completed; Phase 2

Conditions: Respiratory Distress Syndrome

Treatments: Device: nCPAP alone; Drug: Lucinactant for Inhalation

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT02074059

03-CL-1201

4R44HL107000-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The primary objective of this study is to evaluate the safety and tolerability of aerosolized surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses to preterm neonates 29 to 34 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS), compared to neonates receiving nCPAP alone.

Enrollment: 80 patients

Sex: All

Ages: 29 to 34 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent from a legally authorized representative
• Gestational age 29 to 34 completed weeks (34 weeks 6 days) post menstrual age (PMA)
• Successful implementation of controlled nCPAP within 90 minutes after birth
• Spontaneous breathing
• Chest radiograph consistent with RDS
• Need for moderate levels of supplemental oxygen and nCPAP to maintain oxygen saturation of 88% to 95% for at least 30 minutes within the first 21 hours after birth

Exclusion criteria

• Heart rate that cannot be stabilized above 100 beats/minute within 5 minutes of birth
• Recurrent episodes of apnea occurring after the initial newborn resuscitation period (ie, 10 minutes after birth) requiring intermittent positive pressure breaths using inflating pressures above the set CPAP pressure administered manually or mechanically through any patient interface
• A 5 minute Apgar score < 5
• Major congenital malformation(s) and cranial/facial abnormalities that preclude nCPAP, diagnosed antenatally or immediately after birth
• Other diseases or conditions potentially interfering with cardiopulmonary function (eg, hydrops fetalis or congenital infection such as TORCH)
• Known or suspected chromosomal abnormality or syndrome
• Prolong rupture of membranes (PROM) > 2 weeks
• Evidence of hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis
• Need for endotracheal intubation and mechanical ventilation
• Has been administered: another investigational agent or exposure to an investigational medical device, any other surfactant agent, steroid treatment after birth

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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80 participants in 6 patient groups

Aerosolized lucinactant (25 mg/kg)

Experimental group

Description:

25 mg total phospholipids (TPL)/kg: Lucinactant for inhalation with nCPAP

Treatment:

Drug: Lucinactant for Inhalation

Aerosolized lucinactant (50 mg/kg)

Experimental group

Description:

50 mg TPL/kg: Lucinactant for inhalation with nCPAP

Treatment:

Drug: Lucinactant for Inhalation

Aerosolized lucinactant (75 mg/kg)

Experimental group

Description:

75 mg TPL/kg: Lucinactant for inhalation with nCPAP

Treatment:

Drug: Lucinactant for Inhalation

Aerosolized lucinactant (100 mg/kg)

Experimental group

Description:

100 mg TPL/kg: Lucinactant for inhalation with nCPAP; repeat dosing possible if criteria met.

Treatment:

Drug: Lucinactant for Inhalation

Aerosolized lucinactant (150 mg/kg)

Experimental group

Description:

150 mg TPL/kg: Lucinactant for inhalation with nCPAP; repeat dosing possible if criteria met.

Treatment:

Drug: Lucinactant for Inhalation

nCPAP alone

Active Comparator group

Description:

nCPAP therapy alone

Treatment:

Device: nCPAP alone