Trial · NCT02636868
The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age
NCT02636868, Phase 2, Completed, Windtree Therapeutics; results first posted 2021-04-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age. Trials, record NCT02636868. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02636868
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age
- NCT number
- NCT02636868
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 221 participants, actual
- Lead sponsor
- Windtree Therapeutics
- Conditions
- Respiratory Distress Syndrome
- Interventions
- Lucinactant delivered via investigational delivery device, nCPAP
- First posted
- 2015-12-22
- Last updated
- 2021-04-23
- Results first posted
- 2021-04-23
- Limitations and caveats
- Clogging of a in-line filter led to a higher number of treatment interruptions than expected. This primarily affected one batch of supplies that were, by chance, predominantly used in European sites.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Respiratory Failure or Death Due to Respiratory Distress Syndrome (RDS) | 72 hours | Number of participants who had respiratory failure due to RDS or death due to RDS; known as nasal continuous positive airway pressure (nCPAP) failure |
| Secondary | Incidence of Respiratory Failure or Death Due to RDS | 72 hours | Incidence of Respiratory Failure or Death Due to RDS by Intubation or Failure Criteria |
| Secondary | Time to nCPAP Failure | 72 hours | Time from birth to nCPAP Failure |
| Secondary | Incidence of Respiratory Failure or Death Due to RDS With Poisson Distribution Modeling | 72 hours | The measure tests the differences between treatments on respiratory failure or death due to RDS using Poisson distribution modeling, which accounts for the time over which the event could have occurred. |
| Secondary | Incidence of Respiratory Failure or Death Due to RDS | 28 days | Incidence of Respiratory Failure or Death due to RDS by Intubation or Failure Criteria |
| Secondary | Number of Participants With Bronchopulmonary Dysplasia (BPD) | 36 weeks post-menstrual age (PMA) | Summarizes the number of participants with BPD or alive without BPD |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Respiratory Failure or Death Due to Respiratory Distress Syndrome (RDS) | 72 hours | Modified Intent-to-Treat; randomized subjects who received study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Respiratory Failure or Death Due to RDS | 72 hours | Modified Intent-to-Treat Population without Treatment Interruptions | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to nCPAP Failure | 72 hours | Modified Intent-to-Treat; randomized participants who received study treatment | hours | LEAST_SQUARES_MEAN |
| SECONDARY | Incidence of Respiratory Failure or Death Due to RDS With Poisson Distribution Modeling | 72 hours | Modified Intent-to-Treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Respiratory Failure or Death Due to RDS | 28 days | Modified Intent-to-Treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Bronchopulmonary Dysplasia (BPD) | 36 weeks post-menstrual age (PMA) | Modified Intent-to-Treat | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Respiratory Failure or Death Due to Respiratory Distress Syndrome (RDS) | Aerosolized Lucinactant (40 mg TPL/kg) | 31 | Participants | ||
| Number of Participants With Respiratory Failure or Death Due to Respiratory Distress Syndrome (RDS) | Aerosolized Lucinactant (80 mg TPL/kg) | 32 | Participants | ||
| Number of Participants With Respiratory Failure or Death Due to Respiratory Distress Syndrome (RDS) | nCPAP Only | 31 | Participants | ||
| Incidence of Respiratory Failure or Death Due to RDS | Aerosolized Lucinactant (40 mg TPL/kg) | 28 | Participants | ||
| Incidence of Respiratory Failure or Death Due to RDS | Aerosolized Lucinactant (80 mg TPL/kg) | 14 | Participants | ||
| Incidence of Respiratory Failure or Death Due to RDS | nCPAP Only | 31 | Participants | ||
| Time to nCPAP Failure | Aerosolized Lucinactant (40 mg TPL/kg) | 39.3 | Standard Error 2.06 | hours | |
| Time to nCPAP Failure | Aerosolized Lucinactant (80 mg TPL/kg) | 44.8 | Standard Error 2.69 | hours | |
| Time to nCPAP Failure | nCPAP Only | 40.7 | Standard Error 2.44 | hours | |
| Incidence of Respiratory Failure or Death Due to RDS With Poisson Distribution Modeling | Aerosolized Lucinactant (40 mg TPL/kg) | 31 | Participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aerosolized Lucinactant (40 mg TPL/kg) | 73 | |
| Overall Study | STARTED | Aerosolized Lucinactant (80 mg TPL/kg) | 76 | |
| Overall Study | STARTED | nCPAP Only | 72 | |
| Overall Study | COMPLETED | Aerosolized Lucinactant (40 mg TPL/kg) | 73 | |
| Overall Study | COMPLETED | Aerosolized Lucinactant (80 mg TPL/kg) | 75 | |
| Overall Study | COMPLETED | nCPAP Only | 70 | |
| Overall Study | NOT COMPLETED | Aerosolized Lucinactant (40 mg TPL/kg) | 0 | |
| Overall Study | NOT COMPLETED | Aerosolized Lucinactant (80 mg TPL/kg) | 1 | |
| Overall Study | NOT COMPLETED | nCPAP Only | 2 |
Source ClinicalTrials.gov
Adverse events213
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 | Anaemia neonatal | Blood and lymphatic system disorders | Aerosolized Lucinactant (40 mg TPL/kg) | 22 | 70 | 26 |
| other | Anaemia neonatal | Blood and lymphatic system disorders | Aerosolized Lucinactant (80 mg TPL/kg) | 31 | 72 | 37 |
| other | Anaemia neonatal | Blood and lymphatic system disorders | nCPAP Only | 31 | 71 | 52 |
| other | Coagulation disorder neonatal | Blood and lymphatic system disorders | Aerosolized Lucinactant (40 mg TPL/kg) | 2 | 70 | 2 |
| other | Coagulation disorder neonatal | Blood and lymphatic system disorders | Aerosolized Lucinactant (80 mg TPL/kg) | 5 | 72 | 5 |
| other | Coagulation disorder neonatal | Blood and lymphatic system disorders | nCPAP Only | 1 | 71 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Aerosolized Lucinactant (40 mg TPL/kg) | 4 | 70 | 5 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Aerosolized Lucinactant (80 mg TPL/kg) | 6 | 72 | 6 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | nCPAP Only | 5 | 71 | 5 |
| other | Patent ductus arteriosus | Cardiac disorders | Aerosolized Lucinactant (40 mg TPL/kg) | 18 | 70 | 18 |
1 to 10 of 213Source ClinicalTrials.gov
See all 213 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aerosolized Lucinactant (40 mg TPL/kg) | 0 | 70 |
| Total, all-cause mortality | Aerosolized Lucinactant (80 mg TPL/kg) | 1 | 72 |
| Total, all-cause mortality | nCPAP Only | 2 | 71 |
| Total, other adverse events | Aerosolized Lucinactant (40 mg TPL/kg) | 65 | 70 |
| Total, other adverse events | Aerosolized Lucinactant (80 mg TPL/kg) | 69 | 72 |
| Total, other adverse events | nCPAP Only | 66 | 71 |
| Total, serious adverse events | Aerosolized Lucinactant (40 mg TPL/kg) | 16 | 70 |
| Total, serious adverse events | Aerosolized Lucinactant (80 mg TPL/kg) | 14 | 72 |
| Total, serious adverse events | nCPAP Only | 20 | 71 |
Source ClinicalTrials.gov
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.
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/NCT02636868
GET https://conductscience.org/api/trials/v1/NCT02636868/results?page=2