Trial · NCT02074059
Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates
NCT02074059, Phase 2, Completed, Windtree Therapeutics; results first posted 2017-04-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates. Trials, record NCT02074059. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02074059
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates
- NCT number
- NCT02074059
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 80 participants, actual
- Lead sponsor
- Windtree Therapeutics
- Conditions
- Respiratory Distress Syndrome
- Interventions
- Lucinactant for Inhalation, nCPAP alone
- First posted
- 2014-02-28
- Last updated
- 2017-04-21
- Results first posted
- 2017-04-21
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Peri-Dosing Events | Within 48 Hours after Initiation of Study Treatment | Pre-specified adverse events that occured during treatment administration; does not include nCPAP alone |
| Primary | All Cause Mortality | Within 36 Weeks PMA | |
| Primary | Oxygen Saturation Levels | Within 3 Hours of Randomization | Oxygen saturation as determined by pulse oximetry |
| Primary | Serum Electrolytes | 24 Hours Post Randomization | |
| Secondary | PCO2 | Within 3 Hours of Randomization | Arterial carbon dioxide |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Peri-Dosing Events | Within 48 Hours after Initiation of Study Treatment | Safety Population | participants | NUMBER |
| PRIMARY | All Cause Mortality | Within 36 Weeks PMA | Safety Population | participants | NUMBER |
| PRIMARY | Oxygen Saturation Levels | Within 3 Hours of Randomization | Safety Population | percentage of oxygen saturation | MEAN |
| PRIMARY | Serum Electrolytes | 24 Hours Post Randomization | All randomized subjects | mEq/L | MEAN |
| SECONDARY | PCO2 | Within 3 Hours of Randomization | Safety Population | percentage of arterial carbon dioxide | MEAN |
Source ClinicalTrials.gov
Results by group206
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Peri-Dosing Events | Aerolized Lucinactant (25 mg/kg) | Bradycardia | 0 | participants | |
| Peri-Dosing Events | Aerosolized Lucinactant (50 mg/kg) | Bradycardia | 0 | participants | |
| Peri-Dosing Events | Aerosolized Lucinactant (75 mg/kg) | Bradycardia | 0 | participants | |
| Peri-Dosing Events | Aerosolized Lucinactant (100 mg/kg) | Bradycardia | 1 | participants | |
| Peri-Dosing Events | Aerosolized Lucinactant (150 mg/kg) | Bradycardia | 0 | participants | |
| Peri-Dosing Events | Aerolized Lucinactant (25 mg/kg) | Desaturation | 2 | participants | |
| Peri-Dosing Events | Aerosolized Lucinactant (50 mg/kg) | Desaturation | 0 | participants | |
| Peri-Dosing Events | Aerosolized Lucinactant (75 mg/kg) | Desaturation | 1 | participants | |
| Peri-Dosing Events | Aerosolized Lucinactant (100 mg/kg) | Desaturation | 2 | participants | |
| Peri-Dosing Events | Aerosolized Lucinactant (150 mg/kg) | Desaturation | 0 | participants |
1 to 10 of 206Source ClinicalTrials.gov
See all 206 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aerolized Lucinactant (25 mg/kg) | 8 | |
| Overall Study | STARTED | Aerosolized Lucinactant (50 mg/kg) | 8 | |
| Overall Study | STARTED | Aerosolized Lucinactant (75 mg/kg) | 8 | |
| Overall Study | STARTED | Aerosolized Lucinactant (100 mg/kg) | 8 | |
| Overall Study | STARTED | Aerosolized Lucinactant (150 mg/kg) | 8 | |
| Overall Study | STARTED | nCPAP Alone | 40 | |
| Overall Study | COMPLETED | Aerolized Lucinactant (25 mg/kg) | 8 | |
| Overall Study | COMPLETED | Aerosolized Lucinactant (50 mg/kg) | 8 | |
| Overall Study | COMPLETED | Aerosolized Lucinactant (75 mg/kg) | 8 | |
| Overall Study | COMPLETED | Aerosolized Lucinactant (100 mg/kg) | 8 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events714
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 | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Aerolized Lucinactant (25 mg/kg) | 1 | 8 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Aerosolized Lucinactant (50 mg/kg) | 0 | 8 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Aerosolized Lucinactant (75 mg/kg) | 1 | 8 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Aerosolized Lucinactant (100 mg/kg) | 0 | 8 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Aerosolized Lucinactant (150 mg/kg) | 0 | 8 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | nCPAP Alone | 1 | 40 | 1 |
| other | Anaemia Neonatal | Blood and lymphatic system disorders | Aerolized Lucinactant (25 mg/kg) | 5 | 8 | 5 |
| other | Anaemia Neonatal | Blood and lymphatic system disorders | Aerosolized Lucinactant (50 mg/kg) | 3 | 8 | 3 |
| other | Anaemia Neonatal | Blood and lymphatic system disorders | Aerosolized Lucinactant (75 mg/kg) | 1 | 8 | 1 |
| other | Anaemia Neonatal | Blood and lymphatic system disorders | Aerosolized Lucinactant (100 mg/kg) | 1 | 8 | 1 |
1 to 10 of 714Source ClinicalTrials.gov
See all 714 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aerolized Lucinactant (25 mg/kg) | ||
| Total, all-cause mortality | Aerosolized Lucinactant (50 mg/kg) | ||
| Total, all-cause mortality | Aerosolized Lucinactant (75 mg/kg) | ||
| Total, all-cause mortality | Aerosolized Lucinactant (100 mg/kg) | ||
| Total, all-cause mortality | Aerosolized Lucinactant (150 mg/kg) | ||
| Total, all-cause mortality | nCPAP Alone | ||
| Total, other adverse events | Aerolized Lucinactant (25 mg/kg) | 8 | 8 |
| Total, other adverse events | Aerosolized Lucinactant (50 mg/kg) | 8 | 8 |
| Total, other adverse events | Aerosolized Lucinactant (75 mg/kg) | 8 | 8 |
| Total, other adverse events | Aerosolized Lucinactant (100 mg/kg) | 7 | 8 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R44HL107000 | Clinical study of aerosolized KL4 surfactant for neonatal RDS and BPD prevention | SEGAL, ROBERT | WINDTREE THERAPEUTICS, INC. | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2011 to 2018 |
Source NIH RePORTER
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.
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/NCT02074059
GET https://conductscience.org/api/trials/v1/NCT02074059/results?page=2