Acute Respiratory Distress SyndromePhase 2NCT00215553
KL₄Surfactant Treatment in Patients With ARDS
A Phase 2 study testing A.1 Lucinactant, B.3 SoC and A.2 Lucinactant in people with Acute Respiratory Distress Syndrome, run by Windtree Therapeutics at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- A.1 Lucinactant, B.3 SoC and A.2 Lucinactant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- May 2001to Feb 2006
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Discovery Laboratories, Inc.
Warrington, Pennsylvania, 18976-3646
About this study
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).
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).
Read the 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.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- A.1 Lucinactant, B.3 SoC, A.2 Lucinactant, A.3 Lucinactant, A.4 Lucinactant
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A.1 LucinactantDrug
Also called KL₄Surfactant
3 30 mL aliquots at concentrations of 5, 5, and 10 mg/mL
B.3 SoCOther
Also called Negative control
Standard ARDS management and ICU care
A.2 LucinactantDrug
Also called KL₄Surfactant
3 30 mL aliquots at a concentration of 10 mg/mL each
A.3 LucinactantDrug
Also called KL₄Surfactant
2 50 mL aliquots at concentrations of 10 and 20 mg/mL
A.4 LucinactantDrug
Also called KL₄Surfactant
2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed
B.1 LucinactantDrug
Also called KL₄Surfactant
2 50 mL aliquots at concentrations of 10 and 20 mg/mL
B.2 LucinactantDrug
Also called KL₄Surfactant
2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: A.1 Lucinactant |
| 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. Receives: Drug: A.2 Lucinactant |
| 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. Receives: Drug: A.3 Lucinactant |
| 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. Receives: Drug: A.4 Lucinactant |
| 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. Receives: Drug: B.1 Lucinactant |
| 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. Receives: Drug: B.2 Lucinactant |
| 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. Receives: Other: B.3 SoC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28.
Measured: Through 28 days
Secondary outcomes (2)
Mortality
Measured: Through 28 days
Days in ICU
Number of days in ICU
Measured: Through 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMay 2001
- Primary completionFeb 2006
- Study completionFeb 2006
Why it stopped: Slow enrollment and administrative reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Windtree Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy J Gregory, PhD, Study director, Windtree Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215553
- Sponsor's protocol ID
- KL4-ARDS-04
- Status last verified
- Jul 2018
- First submitted
- 14 Sep 2005
- Last updated
- 9 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT00215553
- Acronym / sponsor ID
- KL4-ARDS-04
- Conditions
- Acute Respiratory Distress Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment and administrative reasons
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Windtree TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- May 2001
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 27 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| A.1 Lucinactant | Experimental | Drug: A.1 Lucinactant3 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 | Drug: A.2 Lucinactant3 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 | Drug: A.3 Lucinactant2 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 | Drug: A.4 Lucinactant2 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 | Drug: B.1 Lucinactant2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours. |
| B.2 Lucinactant | Experimental | Drug: B.2 Lucinactant2 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 | Other: B.3 SoCReceived 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. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A.1 LucinactantAlso: KL₄Surfactant3 30 mL aliquots at concentrations of 5, 5, and 10 mg/mL | Drug | A.1 Lucinactant |
| B.3 SoCAlso: Negative controlStandard ARDS management and ICU care | Other | B.3 SoC |
| A.2 LucinactantAlso: KL₄Surfactant3 30 mL aliquots at a concentration of 10 mg/mL each | Drug | A.2 Lucinactant |
| A.3 LucinactantAlso: KL₄Surfactant2 50 mL aliquots at concentrations of 10 and 20 mg/mL | Drug | A.3 Lucinactant |
| A.4 LucinactantAlso: KL₄Surfactant2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed | Drug | A.4 Lucinactant |
| B.1 LucinactantAlso: KL₄Surfactant2 50 mL aliquots at concentrations of 10 and 20 mg/mL | Drug | B.1 Lucinactant |
| B.2 LucinactantAlso: KL₄Surfactant2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed | Drug | B.2 Lucinactant |
Primary outcome
Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28.
Time frame: Through 28 days
2 secondary outcomes
Mortality
Time frame: Through 28 days
Days in ICU
Time frame: Through 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy J Gregory, PhD study director
Windtree Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing A.1 Lucinactant, B.3 SoC and A.2 Lucinactant in people with Acute Respiratory Distress Syndrome, run by Windtree Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28. (time frame: Through 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.