KL₄Surfactant Treatment in Patients With ARDS
Sponsor
Windtree Therapeutics (Industry)
Overall Status
Terminated
CT.gov ID
NCT00215553
Collaborator
(none)
124
1
7
57.1
2.2
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
124 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Controlled Trial Comparing the Safety and Effectiveness of SURFAXIN® (Lucinactant) Delivered Via Bronchopulmonary Segmental Lavage to Standard of Care in Patients With Acute Respiratory Distress Syndrome (ARDS).
Study Start Date
:
May 1, 2001
Actual Primary Completion Date
:
Feb 1, 2006
Actual Study Completion Date
:
Feb 1, 2006
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: A.1 Lucinactant
3 30 mL aliquots at concentrations of 5, 5, and 10 mg/mL
Other Names:
|
| Experimental: 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. |
Drug: A.2 Lucinactant
3 30 mL aliquots at a concentration of 10 mg/mL each
Other Names:
|
| Experimental: 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. |
Drug: A.3 Lucinactant
2 50 mL aliquots at concentrations of 10 and 20 mg/mL
Other Names:
|
| Experimental: 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. |
Drug: A.4 Lucinactant
2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed
Other Names:
|
| Experimental: 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. |
Drug: B.1 Lucinactant
2 50 mL aliquots at concentrations of 10 and 20 mg/mL
Other Names:
|
| Experimental: 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. |
Drug: B.2 Lucinactant
2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed
Other Names:
|
| Other: B.3 SoC 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. |
Other: B.3 SoC
Standard ARDS management and ICU care
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28. [Through 28 days]
Secondary Outcome Measures
- Mortality [Through 28 days]
- Days in ICU [Through 28 days]
Number of days in ICU
Eligibility Criteria
Criteria
Ages Eligible for Study:
16 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Intubated and required mechanical ventilation support
-
Met the criteria for ARDS
-
Partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ≤ 200 mmHg and ≥ 60 mmHg within 60 minutes before randomization
-
Mean blood pressure was ≥ 60 mmHg immediately before randomization
Exclusion Criteria:
-
Had ARDS due solely to a major trauma
-
Was currently participating in another clinical trial or received an experimental drug or device within the previous month
-
A woman of childbearing age, unless pregnancy was excluded by a negative urine hCG test or if the subject was surgically incapable of childbearing
-
Had a previous episode of ARDS that resolved and then recurred during the current hospitalization
-
Had a disease that was sufficiently advanced, in the best judgment of the Principal Investigator, to markedly limit life expectancy to < 6 months
-
Was known to have AIDS or symptomatic HIV (CD4 counts <500). Subjects with asymptomatic HIV were not excluded
-
Received chemotherapy or radiation within the previous 90 days
-
Received an organ transplant other than corneal transplants
-
Received, or was currently receiving, immunosuppression therapy within the last 6 months
-
Had severe neurological damage or the presence of a disease that was likely to significantly prevent weaning from the ventilator
-
Had a best Glasgow Coma Score (GCS) of ≤ 8 or an intracranial pressure ≥ 20 cm H2O prior to the institution of sedatives or paralysis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Discovery Laboratories, Inc. | Warrington | Pennsylvania | United States | 18976-3646 |
Sponsors and Collaborators
- Windtree Therapeutics
Investigators
- Study Director: Timothy J Gregory, PhD, Windtree Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Windtree Therapeutics
ClinicalTrials.gov Identifier:
NCT00215553
Other Study ID Numbers:
- KL4-ARDS-04
First Posted:
Sep 22, 2005
Last Update Posted:
Aug 9, 2018
Last Verified:
Jul 1, 2018
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Recruitment occurred between May 2001 to February 2006 in hospital ICUs |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | A.1 Lucinactant | A.2 Lucinactant | A.3 Lucinactant | A.4 Lucinactant | B.1 Lucinactant | B.2 Lucinactant | B.3 SoC |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | 3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours. | 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 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. | 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. | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. | 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. | Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis. |
| Period Title: Overall Study | |||||||
| STARTED | 5 | 6 | 6 | 5 | 28 | 38 | 36 |
| COMPLETED | 5 | 5 | 4 | 4 | 26 | 32 | 36 |
| NOT COMPLETED | 0 | 1 | 2 | 1 | 2 | 6 | 0 |
Baseline Characteristics
| Arm/Group Title | A.1 Lucinactant | A.2 Lucinactant | A.3 Lucinactant | A.4 Lucinactant | B.1 Lucinactant | B.2 Lucinactant | B.3 SoC | Total |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours. | 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 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. | 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. | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. | 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. | Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis. | Total of all reporting groups |
| Overall Participants | 5 | 6 | 6 | 5 | 28 | 38 | 36 | 124 |
| Age (Count of Participants) | ||||||||
| <=18 years |
1
20%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.8%
|
| Between 18 and 65 years |
2
40%
|
5
83.3%
|
5
83.3%
|
5
100%
|
26
92.9%
|
32
84.2%
|
32
88.9%
|
107
86.3%
|
| >=65 years |
2
40%
|
1
16.7%
|
1
16.7%
|
0
0%
|
2
7.1%
|
6
15.8%
|
4
11.1%
|
16
12.9%
|
| Age (years) [Mean (Standard Deviation) ] | ||||||||
| Mean (Standard Deviation) [years] |
52.7
(24.0)
|
50.5
(17.1)
|
45.6
(16.0)
|
41.6
(6.2)
|
46.3
(12.5)
|
51.8
(13.0)
|
47.3
(12.6)
|
48.5
(13.1)
|
| Sex: Female, Male (Count of Participants) | ||||||||
| Female |
3
60%
|
2
33.3%
|
4
66.7%
|
1
20%
|
9
32.1%
|
22
57.9%
|
16
44.4%
|
57
46%
|
| Male |
2
40%
|
4
66.7%
|
2
33.3%
|
4
80%
|
19
67.9%
|
16
42.1%
|
20
55.6%
|
67
54%
|
| Region of Enrollment (participants) [Number] | ||||||||
| United States |
5
100%
|
6
100%
|
6
100%
|
5
100%
|
25
89.3%
|
32
84.2%
|
23
63.9%
|
102
82.3%
|
| Canada |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
3
10.7%
|
5
13.2%
|
9
25%
|
17
13.7%
|
| Russian Federation |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
2.6%
|
4
11.1%
|
5
4%
|
Outcome Measures
| Title | Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28. |
|---|---|
| Description | |
| Time Frame | Through 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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). |
| Arm/Group Title | A.1 Lucinactant | A.2 Lucinactant | A.3 Lucinactant | A.4 Lucinactant | B.1 Lucinactant | B.2 Lucinactant | B.3 SoC |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | 3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours. | 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 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. | 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. | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. | 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. | Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis. |
| Measure Participants | 5 | 6 | 6 | 5 | 28 | 38 | 36 |
| Number [participants] |
2
40%
|
4
66.7%
|
4
66.7%
|
5
100%
|
20
71.4%
|
26
68.4%
|
29
80.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | B.1 Lucinactant, B.2 Lucinactant |
|---|---|---|
| Comments | Null hypothesis: No difference between treatment groups | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.794 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | B.2 Lucinactant, B.3 SoC |
|---|---|---|
| Comments | Null hypothesis: No difference between treatment groups | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.236 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | B.1 Lucinactant, B.3 SoC |
|---|---|---|
| Comments | Null hypothesis: No difference between treatment groups | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.396 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Mortality |
|---|---|
| Description | |
| Time Frame | Through 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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). |
| Arm/Group Title | A.1 Lucinactant | A.2 Lucinactant | A.3 Lucinactant | A.4 Lucinactant | B.1 Lucinactant | B.2 Lucinactant | B.3 SoC |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | 3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours. | 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 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. | 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. | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. | 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. | Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis. |
| Measure Participants | 5 | 6 | 6 | 5 | 28 | 38 | 36 |
| Number [participants] |
3
60%
|
2
33.3%
|
0
0%
|
0
0%
|
4
14.3%
|
9
23.7%
|
5
13.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | B.1 Lucinactant, B.2 Lucinactant |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.346 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | B.2 Lucinactant, B.3 SoC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.286 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | B.1 Lucinactant, B.3 SoC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.964 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Days in ICU |
|---|---|
| Description | Number of days in ICU |
| Time Frame | Through 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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). |
| Arm/Group Title | A.1 Lucinactant | A.2 Lucinactant | A.3 Lucinactant | A.4 Lucinactant | B.1 Lucinactant | B.2 Lucinactant | B.3 SoC |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | 3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours. | 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 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. | 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. | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. | 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. | Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis. |
| Measure Participants | 5 | 6 | 6 | 5 | 28 | 38 | 36 |
| Mean (Standard Deviation) [days] |
23.4
(7.06)
|
20.5
(7.53)
|
14.3
(9.81)
|
20.0
(2.74)
|
15.3
(9.01)
|
19.9
(7.66)
|
17.4
(8.10)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | B.1 Lucinactant, B.2 Lucinactant |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.028 |
| Comments | ||
| Method | ANOVA | |
| Comments | ANOVA on ranks | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | B.2 Lucinactant, B.3 SoC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.147 |
| Comments | ||
| Method | ANOVA | |
| Comments | ANOVA on ranks | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | B.1 Lucinactant, B.3 SoC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.293 |
| Comments | ||
| Method | ANOVA | |
| Comments | ANOVA on ranks | |
Adverse Events
| Time Frame | 28 days | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||
| Arm/Group Title | A.1 Lucinactant | A.2 Lucinactant | A.3 Lucinactant | A.4 Lucinactant | B.1 Lucinactant | B.2 Lucinactant | B.3 SoC | |||||||
| Arm/Group Description | 3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours. | 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 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. | 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. | 2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. | 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. | Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis. | |||||||
All Cause Mortality |
||||||||||||||
| A.1 Lucinactant | A.2 Lucinactant | A.3 Lucinactant | A.4 Lucinactant | B.1 Lucinactant | B.2 Lucinactant | B.3 SoC | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||
Serious Adverse Events |
||||||||||||||
| A.1 Lucinactant | A.2 Lucinactant | A.3 Lucinactant | A.4 Lucinactant | B.1 Lucinactant | B.2 Lucinactant | B.3 SoC | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/5 (80%) | 2/6 (33.3%) | 1/6 (16.7%) | 0/5 (0%) | 10/28 (35.7%) | 19/38 (50%) | 13/36 (36.1%) | |||||||
| Cardiac disorders | ||||||||||||||
| Cardiac arrest | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 1/38 (2.6%) | 1 | 1/36 (2.8%) | 1 |
| Bradycardia NOS | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 1/38 (2.6%) | 1 | 0/36 (0%) | 0 |
| Pulmonary oedema | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 1/38 (2.6%) | 1 | 0/36 (0%) | 0 |
| Supraventricular tachycardia | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 1/38 (2.6%) | 1 | 0/36 (0%) | 0 |
| Cardio-respiratory arrest | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 1/38 (2.6%) | 1 | 0/36 (0%) | 0 |
| Ventricular arrythmia NOS | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 1/38 (2.6%) | 1 | 0/36 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||
| Gastrointestinal haemorrhage NOS | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/28 (3.6%) | 1 | 0/38 (0%) | 0 | 0/36 (0%) | 0 |
| Necrotising enterocolitis | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/28 (3.6%) | 1 | 0/38 (0%) | 0 | 0/36 (0%) | 0 |
| Colitis | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/28 (3.6%) | 1 | 0/38 (0%) | 0 | 0/36 (0%) | 0 |
| General disorders | ||||||||||||||
| Death NOS | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 2/38 (5.3%) | 2 | 0/36 (0%) | 0 |
| Multi-organ failure | 2/5 (40%) | 2 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/28 (3.6%) | 1 | 2/38 (5.3%) | 2 | 1/36 (2.8%) | 1 |
| Haemorrhage NOS | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 1/38 (2.6%) | 1 | 0/36 (0%) | 0 |
| Hepatobiliary disorders | ||||||||||||||
| Hepatic failure | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 0/38 (0%) | 0 | 1/36 (2.8%) | 1 |
| Infections and infestations | ||||||||||||||
| Sepsis NOS | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 2/28 (7.1%) | 2 | 2/38 (5.3%) | 2 | 0/36 (0%) | 0 |
| Septic shock | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 1/38 (2.6%) | 1 | 1/36 (2.8%) | 1 |
| Empyema NOS | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 1/38 (2.6%) | 1 | 0/36 (0%) | 0 |
| Lung abscess NOS | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 1/38 (2.6%) | 1 | 0/36 (0%) | 0 |
| Pneumonia pneumococcal | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 0/38 (0%) | 0 | 0/36 (0%) | 0 |
| Pneumonia NOS | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 0/38 (0%) | 0 | 1/36 (2.8%) | 1 |
| Injury, poisoning and procedural complications | ||||||||||||||
| Haemothorax | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 0/38 (0%) | 0 | 1/36 (2.8%) | 1 |
| Investigations | ||||||||||||||
| Oxygen saturation decreased | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 1/38 (2.6%) | 1 | 0/36 (0%) | 0 |
| Neurologic examination abnormality | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 0/38 (0%) | 0 | 1/36 (2.8%) | 1 |
| Blood pressure decreased | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 1/38 (2.6%) | 1 | 0/36 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||
| Adenocarcinoma NOS | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 0/38 (0%) | 0 | 1/36 (2.8%) | 1 |
| Nervous system disorders | ||||||||||||||
| Anoxic encephalopathy | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 2/38 (5.3%) | 2 | 0/36 (0%) | 0 |
| Metabolic encephalopathy | 1/5 (20%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 0/38 (0%) | 0 | 0/36 (0%) | 0 |
| Confusion | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/28 (3.6%) | 1 | 0/38 (0%) | 0 | 0/36 (0%) | 0 |
| Hypoxic encephelopathy | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 1/38 (2.6%) | 1 | 0/36 (0%) | 0 |
| Polyneuropathy NOS | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 1/38 (2.6%) | 1 | 0/36 (0%) | 0 |
| Psychiatric disorders | ||||||||||||||
| Agitation aggravated | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/28 (3.6%) | 1 | 0/38 (0%) | 0 | 0/36 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||||
| Renal failure NOS | 1/5 (20%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/28 (3.6%) | 1 | 1/38 (2.6%) | 1 | 1/36 (2.8%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Acute respiratory distress syndrome | 1/5 (20%) | 2 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/28 (3.6%) | 1 | 1/38 (2.6%) | 1 | 1/36 (2.8%) | 1 |
| Hypoxia | 1/5 (20%) | 1 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 | 0/5 (0%) | 0 | 4/28 (14.3%) | 4 | 2/38 (5.3%) | 2 | 2/36 (5.6%) | 2 |
| Pleural effusion | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 2/38 (5.3%) | 2 | 2/36 (5.6%) | 3 |
| Pneumothorax NOS | 1/5 (20%) | 2 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 4/28 (14.3%) | 4 | 7/38 (18.4%) | 10 | 0/36 (0%) | 0 |
| Respiratory failure (exc neonatal) | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 1/38 (2.6%) | 1 | 1/36 (2.8%) | 1 |
| Respiratory gas exchange disorder | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 0/38 (0%) | 0 | 1/36 (2.8%) | 1 |
| Surgical and medical procedures | ||||||||||||||
| Wound dehiscence | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 1/38 (2.6%) | 1 | 0/36 (0%) | 0 |
| Tracheostomy | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 0/38 (0%) | 0 | 1/36 (2.8%) | 1 |
| Subcutaneous emphysema | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 0/38 (0%) | 0 | 1/36 (2.8%) | 1 |
| Vascular disorders | ||||||||||||||
| Hypotension NOS | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 1/38 (2.6%) | 1 | 0/36 (0%) | 0 |
| Pulmonary embolism | 1/5 (20%) | 2 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/28 (3.6%) | 1 | 0/38 (0%) | 0 | 0/36 (0%) | 0 |
| Ischaemic stroke NEC | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/28 (3.6%) | 1 | 0/38 (0%) | 0 | 0/36 (0%) | 0 |
| Venous thrombosis deep limb | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 0/38 (0%) | 0 | 1/36 (2.8%) | 1 |
| Shock haemorrhagic | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 0/38 (0%) | 0 | 1/36 (2.8%) | 1 |
| Gangrene NOS | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 0/38 (0%) | 0 | 1/36 (2.8%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||||||||
| A.1 Lucinactant | A.2 Lucinactant | A.3 Lucinactant | A.4 Lucinactant | B.1 Lucinactant | B.2 Lucinactant | B.3 SoC | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/5 (100%) | 6/6 (100%) | 6/6 (100%) | 5/5 (100%) | 24/28 (85.7%) | 37/38 (97.4%) | 31/36 (86.1%) | |||||||
| Blood and lymphatic system disorders | ||||||||||||||
| Anaemia NOS | 2/5 (40%) | 1/6 (16.7%) | 2/6 (33.3%) | 3/5 (60%) | 5/28 (17.9%) | 8/38 (21.1%) | 5/36 (13.9%) | |||||||
| Leucocytosis NOS | 1/5 (20%) | 1/6 (16.7%) | 1/6 (16.7%) | 1/5 (20%) | 1/28 (3.6%) | 0/38 (0%) | 0/36 (0%) | |||||||
| Thrombocythaemia | 0/5 (0%) | 0 | 1/6 (16.7%) | 0 | 0/6 (0%) | 0 | 1/5 (20%) | 0 | 2/28 (7.1%) | 0 | 3/38 (7.9%) | 0 | 1/36 (2.8%) | 0 |
| Cardiac disorders | ||||||||||||||
| Atrial fibrillation | 1/5 (20%) | 1/6 (16.7%) | 1/6 (16.7%) | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 2/38 (5.3%) | 0 | 0/36 (0%) | 0 | |||
| Bradycardia NOS | 1/5 (20%) | 1/6 (16.7%) | 1/6 (16.7%) | 0/5 (0%) | 0 | 2/28 (7.1%) | 0 | 2/38 (5.3%) | 0 | 1/36 (2.8%) | 0 | |||
| Pulmonary oedema NOS | 1/5 (20%) | 0/6 (0%) | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 1/38 (2.6%) | 0 | 3/36 (8.3%) | 0 | ||
| Gastrointestinal disorders | ||||||||||||||
| Constipation | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 0 | 1/5 (20%) | 0 | 2/28 (7.1%) | 0 | 1/38 (2.6%) | 0 | 2/36 (5.6%) | 0 |
| Diarrhoea NOS | 0/5 (0%) | 0 | 2/6 (33.3%) | 0 | 2/6 (33.3%) | 0 | 1/5 (20%) | 0 | 5/28 (17.9%) | 0 | 4/38 (10.5%) | 0 | 6/36 (16.7%) | 0 |
| Ileus | 0/5 (0%) | 0 | 1/6 (16.7%) | 0 | 0/6 (0%) | 0 | 1/5 (20%) | 0 | 1/28 (3.6%) | 0 | 2/38 (5.3%) | 0 | 1/36 (2.8%) | 0 |
| Nausea | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 0 | 0/5 (0%) | 0 | 1/28 (3.6%) | 0 | 0/38 (0%) | 0 | 2/36 (5.6%) | 0 |
| General disorders | ||||||||||||||
| Multi-organ failure | 2/5 (40%) | 1/6 (16.7%) | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/28 (3.6%) | 0 | 2/38 (5.3%) | 0 | 1/36 (2.8%) | 0 | ||
| Pyrexia | 0/5 (0%) | 0 | 1/6 (16.7%) | 0 | 1/6 (16.7%) | 0 | 3/5 (60%) | 0 | 3/28 (10.7%) | 0 | 2/38 (5.3%) | 0 | 3/36 (8.3%) | 0 |
| Infections and infestations | ||||||||||||||
| Colitis pseudomembranous | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/5 (20%) | 0 | 1/28 (3.6%) | 0 | 1/38 (2.6%) | 0 | 2/36 (5.6%) | 0 |
| Methicillin-resistant Staphyloccal aureus infection | 1/5 (20%) | 0/6 (0%) | 0 | 2/6 (33.3%) | 0 | 0/5 (0%) | 0 | 2/28 (7.1%) | 0 | 1/38 (2.6%) | 0 | 1/36 (2.8%) | 0 | |
| Pneumonia NOS | 2/5 (40%) | 0/6 (0%) | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/28 (3.6%) | 0 | 3/38 (7.9%) | 0 | 2/36 (5.6%) | 0 | ||
| Sepsis NOS | 2/5 (40%) | 1/6 (16.7%) | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 2/28 (7.1%) | 0 | 4/38 (10.5%) | 0 | 1/36 (2.8%) | 0 | ||
| Sinusitis NOS | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/28 (3.6%) | 0 | 3/38 (7.9%) | 0 | 2/36 (5.6%) | 0 |
| Urinary tract infection NOS | 0/5 (0%) | 0 | 1/6 (16.7%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 3/38 (7.9%) | 0 | 3/36 (8.3%) | 0 |
| Septic shock | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 1/38 (2.6%) | 0 | 2/36 (5.6%) | 0 |
| Investigations | ||||||||||||||
| Bacteria NOS sputum identified | 1/5 (20%) | 2/6 (33.3%) | 0/6 (0%) | 1/5 (20%) | 2/28 (7.1%) | 0/38 (0%) | 0 | 0/36 (0%) | 0 | |||||
| Blood pH decreased | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/28 (3.6%) | 0 | 1/38 (2.6%) | 0 | 2/36 (5.6%) | 0 |
| Liver function tests NOS abnormal | 0/5 (0%) | 0 | 1/6 (16.7%) | 0 | 1/6 (16.7%) | 0 | 0/5 (0%) | 0 | 3/28 (10.7%) | 0 | 2/38 (5.3%) | 0 | 1/36 (2.8%) | 0 |
| Oxygen saturation decreased | 1/5 (20%) | 2/6 (33.3%) | 3/6 (50%) | 4/5 (80%) | 3/28 (10.7%) | 5/38 (13.2%) | 0/36 (0%) | 0 | ||||||
| Metabolism and nutrition disorders | ||||||||||||||
| Hypernatraemia | 3/5 (60%) | 2/6 (33.3%) | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 4/38 (10.5%) | 0 | 1/36 (2.8%) | 0 | ||
| Hypokalaemia | 1/5 (20%) | 3/6 (50%) | 2/6 (33.3%) | 1/5 (20%) | 3/28 (10.7%) | 3/38 (7.9%) | 4/36 (11.1%) | |||||||
| Nervous system disorders | ||||||||||||||
| Confusion | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 3/28 (10.7%) | 0 | 2/38 (5.3%) | 0 | 3/36 (8.3%) | 0 |
| Renal and urinary disorders | ||||||||||||||
| Renal failure NOS | 3/5 (60%) | 1/6 (16.7%) | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 4/28 (14.3%) | 0 | 3/38 (7.9%) | 0 | 3/36 (8.3%) | 0 | ||
| Oliguria | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 0/38 (0%) | 0 | 3/36 (8.3%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Acute respiratory distress syndrome | 1/5 (20%) | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 3/28 (10.7%) | 0 | 1/38 (2.6%) | 0 | 1/36 (2.8%) | 0 | |
| Hypoxia | 2/5 (40%) | 1/6 (16.7%) | 3/6 (50%) | 0/5 (0%) | 0 | 7/28 (25%) | 0 | 4/38 (10.5%) | 0 | 2/36 (5.6%) | 0 | |||
| Lung infiltration NOS | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/28 (0%) | 0 | 1/38 (2.6%) | 0 | 2/36 (5.6%) | 0 |
| Pleural effusion | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 0 | 1/5 (20%) | 0 | 2/28 (7.1%) | 0 | 6/38 (15.8%) | 0 | 4/36 (11.1%) | 0 |
| Pneumothorax NOS | 3/5 (60%) | 1/6 (16.7%) | 0/6 (0%) | 0 | 1/5 (20%) | 0 | 5/28 (17.9%) | 0 | 9/38 (23.7%) | 0 | 5/36 (13.9%) | 0 | ||
| Respiratory acidosis | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 0 | 0/5 (0%) | 0 | 4/28 (14.3%) | 0 | 5/38 (13.2%) | 0 | 2/36 (5.6%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||
| Dermatitis NOS | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 0 | 1/5 (20%) | 0 | 4/28 (14.3%) | 0 | 3/38 (7.9%) | 0 | 5/36 (13.9%) | 0 |
| Pressure sore | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 0 | 2/5 (40%) | 0 | 1/28 (3.6%) | 0 | 1/38 (2.6%) | 0 | 2/36 (5.6%) | 0 |
| Surgical and medical procedures | ||||||||||||||
| Subcutaneous emphysema | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/28 (3.6%) | 0 | 2/38 (5.3%) | 0 | 2/36 (5.6%) | 0 |
| Tracheostomy | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 0 | 0/5 (0%) | 0 | 1/28 (3.6%) | 0 | 1/38 (2.6%) | 0 | 2/36 (5.6%) | 0 |
| Vascular disorders | ||||||||||||||
| Hypertension NOS | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 2/6 (33.3%) | 0 | 1/5 (20%) | 0 | 3/28 (10.7%) | 0 | 1/38 (2.6%) | 0 | 4/36 (11.1%) | 0 |
| Hypotension NOS | 0/5 (0%) | 0 | 1/6 (16.7%) | 0 | 3/6 (50%) | 0 | 1/5 (20%) | 0 | 5/28 (17.9%) | 0 | 7/38 (18.4%) | 0 | 5/36 (13.9%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Robert Segal, MD |
|---|---|
| Organization | Discovery Laboratories, Inc. |
| Phone | 215-488-9300 |
| rsegal@discoverylabs.com |
Responsible Party:
Windtree Therapeutics
ClinicalTrials.gov Identifier:
NCT00215553
Other Study ID Numbers:
- KL4-ARDS-04
First Posted:
Sep 22, 2005
Last Update Posted:
Aug 9, 2018
Last Verified:
Jul 1, 2018