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Slow enrollment and administrative reasons
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Lung wash with KL₄Surfactant of individual lung segments using a bronchoscope compared to usual care alone consisting primarily of assisted (mechanical) ventilation in patients with acute respiratory distress syndrome(ARDS).
This is a multinational, multicenter, two-part, Phase 2 study that will evaluate the tolerability, safety, and efficacy of KL₄Surfactant in adult ARDS patients when administered by sequential bronchoscopic lavage into each of the 19 bronchopulmonary segments of the lung and as a bolus instillation into each lung.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A.1 Lucinactant | Experimental | 3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours. |
|
| A.2 Lucinactant | Experimental | 3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours. |
|
| A.3 Lucinactant | Experimental | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. |
|
| A.4 Lucinactant | Experimental | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later. |
|
| B.1 Lucinactant | Experimental | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A.1 Lucinactant | Drug | 3 30 mL aliquots at concentrations of 5, 5, and 10 mg/mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28. | Through 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Through 28 days | |
| Days in ICU | Number of days in ICU | Through 28 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy J Gregory, PhD | Windtree Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Discovery Laboratories, Inc. | Warrington | Pennsylvania | 18976-3646 | United States |
Not provided
Recruitment occurred between May 2001 to February 2006 in hospital ICUs
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| ID | Title | Description |
|---|---|---|
| FG000 | A.1 Lucinactant | 3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours. |
| FG001 | A.2 Lucinactant | 3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours. |
| FG002 | A.3 Lucinactant | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. |
| FG003 | A.4 Lucinactant | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later. |
| FG004 | B.1 Lucinactant | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. |
| FG005 | B.2 Lucinactant | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later. |
| FG006 | B.3 SoC | Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | A.1 Lucinactant | 3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours. |
| BG001 | A.2 Lucinactant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28. | In Part A, 5 subjects provided a reasonable cohort to adequately examine the safety of each treatment regimen. In Part B, 30 subjects were planned to be enrolled in each treatment group (a total of 90 subjects), enough to calculate the dose response curve. Analyses conducted on Intent-to-Treat population (all enrolled subjects). | Posted | Number | participants | Through 28 days |
|
28 days
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A.1 Lucinactant | 3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death NOS | General disorders | MedDRA (3.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia NOS | Blood and lymphatic system disorders | MedDRA (3.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Segal, MD | Discovery Laboratories, Inc. | 215-488-9300 | rsegal@discoverylabs.com |
Not provided
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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|
| B.2 Lucinactant | Experimental | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later. |
|
| B.3 SoC | Other | Received standard ARDS management and ICU care (Standard of Care [SOC]). Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis. |
|
| B.3 SoC | Other | Standard ARDS management and ICU care |
|
|
| A.2 Lucinactant | Drug | 3 30 mL aliquots at a concentration of 10 mg/mL each |
|
|
| A.3 Lucinactant | Drug | 2 50 mL aliquots at concentrations of 10 and 20 mg/mL |
|
|
| A.4 Lucinactant | Drug | 2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed |
|
|
| B.1 Lucinactant | Drug | 2 50 mL aliquots at concentrations of 10 and 20 mg/mL |
|
|
| B.2 Lucinactant | Drug | 2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed |
|
|
3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
| BG002 | A.3 Lucinactant | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. |
| BG003 | A.4 Lucinactant | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later. |
| BG004 | B.1 Lucinactant | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. |
| BG005 | B.2 Lucinactant | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later. |
| BG006 | B.3 SoC | Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis. |
| BG007 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | A.3 Lucinactant | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. |
| OG003 | A.4 Lucinactant | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later. |
| OG004 | B.1 Lucinactant | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. |
| OG005 | B.2 Lucinactant | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later. |
| OG006 | B.3 SoC | Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis. |
|
|
|
| Secondary | Mortality | In Part A, 5 subjects provided a reasonable cohort to adequately examine the safety of each treatment regimen. In Part B, 30 subjects were planned to be enrolled in each treatment group (a total of 90 subjects), enough to calculate the dose response curve. Analyses conducted on Intent-to-Treat population (all enrolled subjects). | Posted | Number | participants | Through 28 days |
|
|
|
|
| Secondary | Days in ICU | Number of days in ICU | In Part A, 5 subjects provided a reasonable cohort to adequately examine the safety of each treatment regimen. In Part B, 30 subjects were planned to be enrolled in each treatment group (a total of 90 subjects), enough to calculate the dose response curve. Analyses conducted on Intent-to-Treat population (all enrolled subjects). | Posted | Mean | Standard Deviation | days | Through 28 days |
|
|
|
|
| 4 |
| 5 |
| 5 |
| 5 |
| EG001 | A.2 Lucinactant | 3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours. | 2 | 6 | 6 | 6 |
| EG002 | A.3 Lucinactant | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. | 1 | 6 | 6 | 6 |
| EG003 | A.4 Lucinactant | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later. | 0 | 5 | 5 | 5 |
| EG004 | B.1 Lucinactant | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. | 10 | 28 | 24 | 28 |
| EG005 | B.2 Lucinactant | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later. | 19 | 38 | 37 | 38 |
| EG006 | B.3 SoC | Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis. | 13 | 36 | 31 | 36 |
| Multi-organ failure | General disorders | MedDRA (3.1) | Systematic Assessment |
|
| Sepsis NOS | Infections and infestations | MedDRA (3.1) | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (3.1) | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA (3.1) | Systematic Assessment |
|
| Anoxic encephalopathy | Nervous system disorders | MedDRA (3.1) | Systematic Assessment |
|
| Metabolic encephalopathy | Nervous system disorders | MedDRA (3.1) | Systematic Assessment |
|
| Renal failure NOS | Renal and urinary disorders | MedDRA (3.1) | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (3.1) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (3.1) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (3.1) | Systematic Assessment |
|
| Pneumothorax NOS | Respiratory, thoracic and mediastinal disorders | MedDRA (3.1) | Systematic Assessment |
|
| Hypotension NOS | Vascular disorders | MedDRA (3.1) | Systematic Assessment |
|
| Pulmonary embolism | Vascular disorders | MedDRA (3.1) | Systematic Assessment |
|
| Ischaemic stroke NEC | Vascular disorders | MedDRA (3.1) | Systematic Assessment |
|
| Venous thrombosis deep limb | Vascular disorders | MedDRA (3.1) | Systematic Assessment |
|
| Gastrointestinal haemorrhage NOS | Gastrointestinal disorders | MedDRA (3.1) | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA (3.1) | Systematic Assessment |
|
| Necrotising enterocolitis | Gastrointestinal disorders | MedDRA (3.1) | Systematic Assessment |
|
| Bradycardia NOS | Cardiac disorders | MedDRA (3.1) | Systematic Assessment |
|
| Pulmonary oedema | Cardiac disorders | MedDRA (3.1) | Systematic Assessment |
|
| Empyema NOS | Infections and infestations | MedDRA (3.1) | Systematic Assessment |
|
| Lung abscess NOS | Infections and infestations | MedDRA (3.1) | Systematic Assessment |
|
| Respiratory failure (exc neonatal) | Respiratory, thoracic and mediastinal disorders | MedDRA (3.1) | Systematic Assessment |
|
| Neurologic examination abnormality | Investigations | MedDRA (3.1) | Systematic Assessment |
|
| Agitation aggravated | Psychiatric disorders | MedDRA (3.1) | Systematic Assessment |
|
| Confusion | Nervous system disorders | MedDRA (3.1) | Systematic Assessment |
|
| Pneumonia pneumococcal | Infections and infestations | MedDRA (3.1) | Systematic Assessment |
|
| Hypoxic encephelopathy | Nervous system disorders | MedDRA (3.1) | Systematic Assessment |
|
| Haemorrhage NOS | General disorders | MedDRA (3.1) | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA (3.1) | Systematic Assessment |
|
| Haemothorax | Injury, poisoning and procedural complications | MedDRA (3.1) | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (3.1) | Systematic Assessment |
|
| Polyneuropathy NOS | Nervous system disorders | MedDRA (3.1) | Systematic Assessment |
|
| Ventricular arrythmia NOS | Cardiac disorders | MedDRA (3.1) | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA (3.1) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (3.1) | Systematic Assessment |
|
| Wound dehiscence | Surgical and medical procedures | MedDRA (3.1) | Systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA (3.1) | Systematic Assessment |
|
| Adenocarcinoma NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (3.1) | Systematic Assessment |
|
| Gangrene NOS | Vascular disorders | MedDRA (3.1) | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA (3.1) | Systematic Assessment |
|
| Respiratory gas exchange disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (3.1) | Systematic Assessment |
|
| Tracheostomy | Surgical and medical procedures | MedDRA (3.1) | Systematic Assessment |
|
| Subcutaneous emphysema | Surgical and medical procedures | MedDRA (3.1) | Systematic Assessment |
|
| Pneumonia NOS | Infections and infestations | MedDRA (3.1) | Systematic Assessment |
|
| Leucocytosis NOS | Blood and lymphatic system disorders | MedDRA (3.1) | Systematic Assessment |
|
| Thrombocythaemia | Blood and lymphatic system disorders | MedDRA (3.1) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (3.1) | Systematic Assessment |
|
| Bradycardia NOS | Cardiac disorders | MedDRA (3.1) | Systematic Assessment |
|
| Pulmonary oedema NOS | Cardiac disorders | MedDRA (3.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (3.1) | Systematic Assessment |
|
| Diarrhoea NOS | Gastrointestinal disorders | MedDRA (3.1) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (3.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (3.1) | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA (3.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (3.1) | Systematic Assessment |
|
| Colitis pseudomembranous | Infections and infestations | MedDRA (3.1) | Systematic Assessment |
|
| Methicillin-resistant Staphyloccal aureus infection | Infections and infestations | MedDRA (3.1) | Systematic Assessment |
|
| Pneumonia NOS | Infections and infestations | MedDRA (3.1) | Systematic Assessment |
|
| Sepsis NOS | Infections and infestations | MedDRA (3.1) | Systematic Assessment |
|
| Sinusitis NOS | Infections and infestations | MedDRA (3.1) | Systematic Assessment |
|
| Urinary tract infection NOS | Infections and infestations | MedDRA (3.1) | Systematic Assessment |
|
| Bacteria NOS sputum identified | Investigations | MedDRA (3.1) | Systematic Assessment |
|
| Blood pH decreased | Investigations | MedDRA (3.1) | Systematic Assessment |
|
| Liver function tests NOS abnormal | Investigations | MedDRA (3.1) | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA (3.1) | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (3.1) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (3.1) | Systematic Assessment |
|
| Confusion | Nervous system disorders | MedDRA (3.1) | Systematic Assessment |
|
| Renal failure NOS | Renal and urinary disorders | MedDRA (3.1) | Systematic Assessment |
|
| Oliguria | Renal and urinary disorders | MedDRA (3.1) | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (3.1) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (3.1) | Systematic Assessment |
|
| Lung infiltration NOS | Respiratory, thoracic and mediastinal disorders | MedDRA (3.1) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (3.1) | Systematic Assessment |
|
| Pneumothorax NOS | Respiratory, thoracic and mediastinal disorders | MedDRA (3.1) | Systematic Assessment |
|
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA (3.1) | Systematic Assessment |
|
| Dermatitis NOS | Skin and subcutaneous tissue disorders | MedDRA (3.1) | Systematic Assessment |
|
| Pressure sore | Skin and subcutaneous tissue disorders | MedDRA (3.1) | Systematic Assessment |
|
| Subcutaneous emphysema | Surgical and medical procedures | MedDRA (3.1) | Systematic Assessment |
|
| Tracheostomy | Surgical and medical procedures | MedDRA (3.1) | Systematic Assessment |
|
| Hypertension NOS | Vascular disorders | MedDRA (3.1) | Systematic Assessment |
|
| Hypotension NOS | Vascular disorders | MedDRA (3.1) | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (3.1) | Systematic Assessment |
|
Not provided
| 95 |
| Superiority or Other |
| Cochran-Mantel-Haenszel | 0.964 | 95 | Superiority or Other |
| 0.147 |
| 95 |
| Superiority or Other |
| ANOVA | ANOVA on ranks | 0.293 | 95 | Superiority or Other |