5 completed, 4 terminated. 8 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 8 | Completed 5, Terminated 3 |
| Phase 3 | 1 | Terminated 1 |
Follow lucinactant: new trials by email Literature Review of lucinactant trials Research Report on lucinactant
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| The Safety and Preliminary Tolerability of Lyophilized Lucinactant in Adults With Coronavirus Disease 2019 (COVID-19) Lucinactant - COVID-19, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) | Phase 2 | Completed | Windtree Therapeutics | 20 | 2021-01-05 | 2023-06-23 |
| A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age Lucinactant for Inhalation, nCPAP Only - Respiratory Distress Syndrome, Newborn | Phase 2 | Terminated | Windtree Therapeutics | 12 | 2020-04-18 | 2023-05-24 |
| The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age Lucinactant delivered via investigational delivery device, nCPAP - Respiratory Distress Syndrome | Phase 2 | Completed | Windtree Therapeutics | 221 | 2015-12-01 | 2021-04-23 |
| Trial To Assess The Safety And Tolerability Of Lucinactant For Inhalation In Preterm Neonates 26 to 28 Weeks PMA Lucinactant for inhalation, nCPAP alone - Respiratory Distress Syndrome | Phase 2 | Terminated | Windtree Therapeutics | 48 | 2015-08-01 | 2019-07-23 |
| Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates Lucinactant for Inhalation, nCPAP alone - Respiratory Distress Syndrome | Phase 2 | Completed | Windtree Therapeutics | 80 | 2014-02-01 | 2017-04-21 |
| Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease Lucinactant first, Placebo first - Cystic Fibrosis | Phase 2 | Completed | University of North Carolina, Chapel Hill | 16 | 2008-10-01 | 2017-03-13 |
| Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old Lucinactant, Sham Comparator - Acute Hypoxemic Respiratory Failure | Phase 2 | Completed | Windtree Therapeutics | 165 | 2007-06-01 | 2012-05-03 |
| SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants. Lucinactant 175 mg/kg, Lucinactant 90 mg/kg, Placebo - Respiratory Distress Syndrome, Newborn, Premature Birth | Phase 2 | Terminated | Windtree Therapeutics | 136 | 2005-02-01 | 2012-06-13 |
| Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome Lucinactant, Standard Care - Meconium Aspiration | Phase 3 | Terminated | Windtree Therapeutics | 69 | 2000-03-01 | 2012-05-03 |
Respiratory Distress Syndrome (5) · Respiratory Distress Syndrome, Newborn (2) · Acute Lung Injury (1) · Bronchopulmonary Dysplasia (1) · COVID-19 (1) · Cystic Fibrosis (1) · Meconium Aspiration Syndrome (1) · Premature Birth (1) · Rare Diseases (1) · Respiratory Insufficiency (1) · Respiratory Tract Diseases (1)
Windtree Therapeutics (8) · University of North Carolina, Chapel Hill (1)
United States (8) · Chile (3) · Poland (3) · Canada (2) · Argentina (1) · Colombia (1) · Hungary (1) · Ireland (1) · Netherlands (1)
Carlos Guardia, MD (2) · Adrienne Randolph, MD (1) · Matthew M Laughon, MD, MPH (1) · Neal Thomas, MD (1) · Robert Segal, MD, FACP (1) · Scott H Donaldson, MD (1) · Steve G Simonson, MD (1) · Steve Simonson, MD (1) · Steven Simonson, MD (1) · Thomas E Wiswell (1) · Yuh-Chin T Huang, MD, MHS (1)
PMID 19117865, PMID 22791092, PMID 34337553, PMID 35474746, PMID 42536986
R44HL107000 (1)