- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04264156
A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age
A Multinational, Multicenter, Masked, Randomized, Controlled Study to Assess the Safety and Efficacy of Lucinactant for Inhalation Versus nCPAP Alone in Preterm Neonates 26 to 32 Weeks Gestational Age With RDS
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Bytom, Poland, 41-902
- Szpital Specjalistyczny nr 2 w Bytomiu Oddzial Noworodkow Blok Va
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Poznan, Poland, 60-535
- Ginekologiczno-Polozniczy Szpital Kliniczny Uniwewersytetu Medycznego im. Karola Marcinkowskiego
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Szczecin, Poland, 70-780
- Samodzielny Publiczny Spcjalistyczny Zaklad Opieki Zdrowotnej "Zdroje", Oddzial Noworodkow
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
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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).
Other Names:
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Sham Comparator: nCPAP Only
nCPAP Only as sham comparator.
Bubble nCPAP is standard of care.
Treatment time behind barrier to match active treatment delivery time
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Nasal continuous positive airway pressure (nCPAP) alone
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Respiratory Failure or Death
Time Frame: 28 days of life
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Number of participants with respiratory failure due to RDS or death.
Respiratory failure due to RDS is defined as intubation for mechanical ventilation and/or surfactant administration
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28 days of life
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number With BPD
Time Frame: 36 weeks post-menstrual age (PMA)
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Number of participants with bronchopulmonary dysplasia (BPD)
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36 weeks post-menstrual age (PMA)
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Mortality
Time Frame: 36 weeks PMA or 28 days of life (whichever is later)
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All-cause mortality
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36 weeks PMA or 28 days of life (whichever is later)
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Number of Participants With Common Complications of Prematurity
Time Frame: 36 weeks PMA
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Number of participants with complications including intraventricular hemorrhage, periventricular leukomalacia, pulmonary hemorrhage, apnea, necrotizing enterocolitis, patent ductus arteriosus, acquired sepsis, and retinopathy of prematurity.
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36 weeks PMA
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carlos Guardia, MD, Windtree Therapeutics, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-CL-1702
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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