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Lucinactant delivered via investigational delivery device

Phase 2

Respiratory Distress Syndrome | Small molecule | Other |Windtree Therapeutics, Inc.|Last Updated: Apr 23, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment221

FDA Designations

No designations recorded

Clinical trial landscape

Lucinactant delivered via investigational delivery device · 1 trial · 1 indication

Phase 2 1
NCT02636868The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational AgeRespiratory Distress Syndrome
COMPLETED221 Analytics
PHASE2COMPLETED
The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age
Respiratory Distress Syndrome
NCT02636868221
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Study Endpoints

Primary Endpoints

Number of Participants With Respiratory Failure or Death Due to Respiratory Distress Syndrome (RDS)
72 hours

Number of participants who had respiratory failure due to RDS or death due to RDS; known as nasal continuous positive airway pressure (nCPAP) failure

Secondary Endpoints

Incidence of Respiratory Failure or Death Due to RDS
72 hours
Time to nCPAP Failure
72 hours
Incidence of Respiratory Failure or Death Due to RDS With Poisson Distribution Modeling
72 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Aerosolized lucinactant (low dose)EXPERIMENTALLucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Aerosolized lucinactant (high dose)EXPERIMENTALLucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
nasal CPAPACTIVE_COMPARATORnCPAP alone

Interventions

NameTypeDescription
Lucinactant delivered via investigational delivery deviceDRUGLucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAPDRUGNasal CPAP
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Eligibility Criteria

Age Range26 Weeks to 32 Weeks
SexALL
Healthy VolunteersNo
Study Sites54

Inclusion Criteria: 1. Signed informed consent form (ICF) from legally authorized representative 2. 26 0/7 to 32 6/7 completed weeks gestation PMA 3. Successful implementation of non-invasive support or ventilation within 90 minutes after birth 4. Spontaneous breathing 5. Chest radiograph consisten...

Countries:United StatesCanadaChileColombiaHungaryIrelandNetherlandsPoland
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Competitive Landscape -Acute Respiratory Distress Syndrome 15 trials (matched to "Respiratory Distress Syndrome")

CompanyTickerTrialsLead PhaseDrugs
Thermo Fisher Scientific Inc.TMO4PHASE2Cohort A: vilobelimab, Cohort B: paridiprubart, Cohort C: bevacizumab
Akebia Therapeutics, Inc.AKBA1PHASE2Vadadustat
Rigel Pharmaceuticals, Inc.RIGL1PHASE2Fostamatinib
CytoSorbents CorporationCTSO1 - Undisclosed
Fresenius Medical Care AG Sponsored ADRFMS2 - Undisclosed
Baxter International Inc.BAX1 - Undisclosed
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