A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-18

Study Completion Date

2021-03-28

Brief Summary

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This study is to evaluate the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, in comparison to nCPAP alone, in preterm neonates with RDS, as assessed by the incidence of and time to respiratory failure and/or death due to RDS in the first 72 hours and 28 days of life. Half of the subjects will receive lucinactant for inhalation and half will receive standard of care (nCPAP alone).

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Detailed Description

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An unmet medical need exists for a means to deliver surfactant replacement therapy (SRT) to preterm neonates with RDS supported with nCPAP early in the course of the disease. This strategy has the potential to improve RDS prior to the development of respiratory failure, thereby avoiding the need for endotracheal intubation and mechanical ventilation (MV), or reduce the duration of MV, and the resultant potential for morbidity and complications. The ability to administer SRT via aerosol has the potential to address this unmet need.

Lucinactant for inhalation (AEROSURF) is an investigational drug-device combination product, designed to deliver aerosolized SRT to preterm neonates with RDS who are being supported with nCPAP. The drug component of lucinactant for inhalation is lyophilized lucinactant, a lyophilized form of SURFAXIN® (lucinactant) Intratracheal Suspension. The device component, the AEROSURF Delivery System (ADS), the next-generation device following use of the prototype device in earlier trials, uses novel technology to aerosolize lucinactant for inhalation.

This study evaluates the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, in comparison to nCPAP alone, in preterm neonates with RDS, as assessed by pre-specified outcome measures. In addition, this study will evaluate the device and the ability to administer up to 3 repeat doses.

Conditions

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Respiratory Distress Syndrome, Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a multinational, multicenter, double-blind (masked), parallel group, randomized, controlled study, in preterm neonates 26 to 32 completed weeks post-menstrual age (PMA).

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

The first 2 subjects at each site for each cohort will be dosed with open-label active treatment for training purposes. Following the first 2 subjects, preparation and delivery of treatment will be blinded from the study staff. Treatment will be delivered behind a partition and no information about treatment will be given to investigator, parents, or other applicable study staff.

Study Groups

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Lucinactant (160 mg/kg) + nCPAP

Lucinactant for inhalation, 160 mg total phospholipids (TPL)/kg Delivered as an aerosol once, with up to 3 repeats of 80 mg/kg allowed within 36 hours of birth

Group Type EXPERIMENTAL

Lucinactant for Inhalation

Intervention Type COMBINATION_PRODUCT

A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nasal continuous positive airway pressure (nCPAP).

nCPAP Only

nCPAP Only as sham comparator. Bubble nCPAP is standard of care. Treatment time behind barrier to match active treatment delivery time

Group Type SHAM_COMPARATOR

nCPAP Only

Intervention Type OTHER

Nasal continuous positive airway pressure (nCPAP) alone

Interventions

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Lucinactant for Inhalation

A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nasal continuous positive airway pressure (nCPAP).

Intervention Type COMBINATION_PRODUCT

nCPAP Only

Nasal continuous positive airway pressure (nCPAP) alone

Intervention Type OTHER

Other Intervention Names

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AEROSURF

Eligibility Criteria

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Inclusion Criteria

* Signed ICF from legally authorized representative.
* Gestational age: 26 to 32+6 weeks PMA.
* Successful implementation of non-invasive support or ventilation within 30 minutes after birth.
* Spontaneous breathing.
* Investigator determination of RDS. A chest x-ray should be obtained before treatment to confirm the diagnosis.
* Within the first 6 hours after birth, requires an nCPAP of 5 to 7 cm H2O that is clinically indicated for at least 15 minutes with an FiO2 \> 0.25 to ≤ 0.35 to maintain SpO2 of 90% to 95%.

Exclusion Criteria

* A heart rate that cannot be stabilized above 100 bpm within 5 minutes of birth.
* Recurrent episodes of apnea requiring positive pressure ventilation.
* A 5 minute Apgar score \< 5.
* Major congenital malformation(s) or craniofacial abnormalities that preclude the use of nCPAP.
* Clinically significant diseases or conditions other than RDS which could potentially interfere with cardiopulmonary function.
* A known or suspected chromosomal abnormality or syndrome.
* Premature rupture of membranes \> 3 weeks.
* Hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis.
* A need for intubation and/or invasive mechanical ventilation at any time before enrollment into the study.
* The administration (or plan for administration) of another investigational agent or investigational medical device, any other surfactant agent, or systemic corticosteroids.
* Presence of air leak on the baseline chest radiograph or diagnosed via ultrasound or illumination.

Minimum Eligible Age

30 Minutes

Maximum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No