Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
nCPAP · 1 trial · 1 indication
Number of participants who had respiratory failure due to RDS or death due to RDS; known as nasal continuous positive airway pressure (nCPAP) failure
| Arm | Type | Description |
|---|---|---|
| Aerosolized lucinactant (low dose) | EXPERIMENTAL | Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met. |
| Aerosolized lucinactant (high dose) | EXPERIMENTAL | Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met. |
| nasal CPAP | ACTIVE_COMPARATOR | nCPAP alone |
| Name | Type | Description |
|---|---|---|
| Lucinactant delivered via investigational delivery device | DRUG | Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product) |
| nCPAP | DRUG | Nasal CPAP |
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...
nCPAP, or nasal continuous positive airway pressure, is used for Respiratory Distress Syndrome in premature neonates. It is being studied as a therapy to support breathing in infants born at 26 to 32 weeks gestational age. The treatment is delivered through the nose to help keep the airways open.
nCPAP is being developed by Windtree Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker WINT. The company is conducting clinical research to evaluate the safety and efficacy of this treatment for Respiratory Distress Syndrome in premature infants.
nCPAP is in Phase 2 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The Phase 2 trial has been completed, and the results are being evaluated for safety and efficacy.
nCPAP has one completed Phase 2 clinical trial registered under NCT02636868. This trial, titled 'The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age,' enrolled 221 participants across multiple countries including the United States, Canada, Chile, Colombia, Hungary, Ireland, Netherlands, and Poland.
Yes, nCPAP is the same as Lucinactant for Inhalation. The clinical trial NCT02636868 evaluates the safety and efficacy of Lucinactant for Inhalation, which is delivered via nCPAP. This therapy is being studied for Respiratory Distress Syndrome in premature neonates between 26 and 32 weeks gestational age.