8 completed, 6 terminated, 2 active not recruiting, 1 suspended. 14 Phase 2, 2 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 14 | Completed 8, Terminated 5, Active not recruiting 1 |
| Phase 1 | 2 | Active not recruiting 2 |
| Phase 3 | 1 | Terminated 1 |
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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 |
|---|---|---|---|---|---|---|
| A Safety and Efficacy Trial of Istaroxime for Cardiogenic Shock Stage C Istaroxime, Placebo - Cardiogenic Shock | Phase 1 / Phase 2 | Active not recruiting | Windtree Therapeutics | 20 | 2024-06-01 | 2025-08-20 |
| TH1902 in Patients With Advanced Solid Tumors TH1902 - Solid Tumor, TNBC - Triple-Negative Breast Cancer | Phase 1 | Active not recruiting | Theratechnologies | 70 | 2021-03-04 | 2025-04-15 |
| 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 |
| The Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock Istaroxime, Placebo - Cardiogenic Shock | Phase 2 | Completed | Windtree Therapeutics | 90 | 2020-09-28 | 2025-02-04 |
| 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 |
| The Clinical Study of the Safety and Efficacy of Istaroxime in Treatment of Acute Decompensated Heart Failure Placebo, Istaroxime - Acute Decompensated Heart Failure | Phase 2 | Completed | Windtree Therapeutics | 120 | 2015-12-01 | 2023-05-24 |
| Antihypertensive Effect of Different Doses of Rostafuroxin in Comparison With Losartan Rostafuroxin, Losartan - Hypertension | Phase 2 | Completed | Windtree Therapeutics | 240 | 2015-12-01 | 2023-02-21 |
| 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 |
| Effects of Volume Guarantee With Pressure Supported vs. Synchronized Intermittent Mandatory Ventilation in VLBW Infants PSV+VG mode versus SIMV+VG mode - Respiratory Distress Syndrome | Suspended | Children's Hospitals and Clinics of Minnesota | 16 | 2006-02-01 | 2007-11-07 | |
| 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 |
| Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants Aerosolized lucinactant - Respiratory Distress Syndrome | Phase 2 | Terminated | Windtree Therapeutics | 17 | 2005-01-01 | 2012-06-13 |
| KL₄Surfactant Treatment in Patients With ARDS A.1 Lucinactant, B.3 SoC, A.2 Lucinactant - Acute Respiratory Distress Syndrome | Phase 2 | Terminated | Windtree Therapeutics | 124 | 2001-05-01 | 2018-08-09 |
| 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 (8) · Premature Birth (2) · Respiratory Distress Syndrome, Newborn (2) · Shock, Cardiogenic (2) · Acute Lung Injury (1) · Bronchopulmonary Dysplasia (1) · COVID-19 (1) · Carcinoma, Ovarian Epithelial (1) · Cystic Fibrosis (1) · Endometrial Neoplasms (1) · Heart Failure (1) · Hypertension (1) · Meconium Aspiration Syndrome (1) · Melanoma (1) · Prostatic Neoplasms (1)
lucinactant (9) · Surface-Active Agents (4) · Inhalation (3) · Istaroxime (3) · Continuous Positive Airway Pressure (2) · Lactic Acid (1) · Losartan (1) · Saline Solution (1) · Standard of Care (1) · rostafuroxin (1) · sinapultide (1)
United States (14) · Poland (5) · Argentina (3) · Canada (3) · Chile (3) · Italy (3) · China (1) · Colombia (1) · Hungary (1) · Ireland (1) · Israel (1) · Netherlands (1) · Taiwan (1)
Carlos Guardia, MD (2) · Adrienne Randolph, MD (1) · Bianchi Giuseppe, MD (1) · Funda Meric-Burnstam, MD (1) · Giuseppe Bianchi, MD (1) · Marco Metra, MD (1) · Mark Mammel, MD (1) · Matthew M Laughon, MD, MPH (1) · Neal Thomas, MD (1) · Neil Finer, MD (1) · Robert Segal, MD, FACP (1) · Scott H Donaldson, MD (1) · Steve G Simonson, MD (1) · Steve Simonson, MD (1) · Steven G Simonson, MD (1)
PMID 19117865, PMID 20455772, PMID 22791092, PMID 31975496, PMID 33649520, PMID 34337553, PMID 35474746, PMID 35867804, PMID 37075941, PMID 42536986
R44HL107000 (1)