drugset / Trial / NCT02074059
Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates
Phase 2
Completed
80 enrolled
Windtree Therapeutics
National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedSequentialOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2014-02
- Primary completion
- 2015-10
- Completion
- 2015-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lucinactant | Peptide | 25 mg/kg | Inhaled |
| Subject | Lucinactant | Peptide | 50 mg/kg | Inhaled |
| Subject | Lucinactant | Peptide | 75 mg/kg | Inhaled |
| Subject | Lucinactant | Peptide | 100 mg/kg | Inhaled |
| Subject | Lucinactant | Peptide | 150 mg/kg | Inhaled |