Trial · NCT00215553

KL₄Surfactant Treatment in Patients With ARDS

NCT00215553, Phase 2, Terminated, Windtree Therapeutics; results first posted 2012-04-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. KL₄Surfactant Treatment in Patients With ARDS. Trials, record NCT00215553. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00215553

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: KL₄Surfactant Treatment in Patients With ARDS
NCT number: NCT00215553
Status: Terminated
Phases: Phase 2
Enrollment: 124 participants, actual
Lead sponsor: Windtree Therapeutics
Conditions: Acute Respiratory Distress Syndrome
Interventions: A.1 Lucinactant, B.3 SoC, A.2 Lucinactant, A.3 Lucinactant, A.4 Lucinactant, B.1 Lucinactant, B.2 Lucinactant
First posted: 2005-09-22
Last updated: 2018-08-09
Results first posted: 2012-04-27

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28.	Through 28 days
Secondary	Mortality	Through 28 days
Secondary	Days in ICU	Through 28 days	Number of days in ICU

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28.	Through 28 days	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).	participants	NUMBER
SECONDARY	Mortality	Through 28 days	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).	participants	NUMBER
SECONDARY	Days in ICU	Through 28 days	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).	days	MEAN

Source ClinicalTrials.gov

Results by group21

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28.	A.1 Lucinactant	2	participants
Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28.	A.2 Lucinactant	4	participants
Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28.	A.3 Lucinactant	4	participants
Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28.	A.4 Lucinactant	5	participants
Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28.	B.1 Lucinactant	20	participants
Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28.	B.2 Lucinactant	26	participants
Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28.	B.3 SoC	29	participants
Mortality	A.1 Lucinactant	3	participants
Mortality	A.2 Lucinactant	2	participants
Mortality	A.3 Lucinactant	0	participants

1 to 10 of 21Source ClinicalTrials.gov

See all 21 results by group

Participant flow21

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	A.1 Lucinactant	5
Overall Study	STARTED	A.2 Lucinactant	6
Overall Study	STARTED	A.3 Lucinactant	6
Overall Study	STARTED	A.4 Lucinactant	5
Overall Study	STARTED	B.1 Lucinactant	28
Overall Study	STARTED	B.2 Lucinactant	38
Overall Study	STARTED	B.3 SoC	36
Overall Study	COMPLETED	A.1 Lucinactant	5
Overall Study	COMPLETED	A.2 Lucinactant	5
Overall Study	COMPLETED	A.3 Lucinactant	4

1 to 10 of 21Source ClinicalTrials.gov

See all 21 participant flow

Adverse events602

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia NOS	Blood and lymphatic system disorders	A.1 Lucinactant	2	5
other	Anaemia NOS	Blood and lymphatic system disorders	A.2 Lucinactant	1	6
other	Anaemia NOS	Blood and lymphatic system disorders	A.3 Lucinactant	2	6
other	Anaemia NOS	Blood and lymphatic system disorders	A.4 Lucinactant	3	5
other	Anaemia NOS	Blood and lymphatic system disorders	B.1 Lucinactant	5	28
other	Anaemia NOS	Blood and lymphatic system disorders	B.2 Lucinactant	8	38
other	Anaemia NOS	Blood and lymphatic system disorders	B.3 SoC	5	36
other	Leucocytosis NOS	Blood and lymphatic system disorders	A.1 Lucinactant	1	5
other	Leucocytosis NOS	Blood and lymphatic system disorders	A.2 Lucinactant	1	6
other	Leucocytosis NOS	Blood and lymphatic system disorders	A.3 Lucinactant	1	6

1 to 10 of 602Source ClinicalTrials.gov

See all 602 adverse events

Adverse event totals21

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	A.1 Lucinactant
Total, all-cause mortality	A.2 Lucinactant
Total, all-cause mortality	A.3 Lucinactant
Total, all-cause mortality	A.4 Lucinactant
Total, all-cause mortality	B.1 Lucinactant
Total, all-cause mortality	B.2 Lucinactant
Total, all-cause mortality	B.3 SoC
Total, other adverse events	A.1 Lucinactant	5	5
Total, other adverse events	A.2 Lucinactant	6	6
Total, other adverse events	A.3 Lucinactant	6	6

1 to 10 of 21Source ClinicalTrials.gov

See all 21 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00215553

GET https://conductscience.org/api/trials/v1/NCT00215553/results?page=2

API reference For AI assistants