Trial To Assess The Safety And Tolerability Of Lucinactant For Inhalation In Preterm Neonates 26 to 28 Weeks PMA
Sponsor
Windtree Therapeutics (Industry)
Overall Status
Terminated
CT.gov ID
NCT02528318
Collaborator
(none)
48
20
5
24.3
2.4
0.1
Study Details
Study Description
Brief Summary
This study is to evaluate the safety and tolerability of lucinactant for inhalation, administered as an aerosol in up to four escalating doses to preterm neonates 26 to 28 weeks gestational age who are receiving nCPAP for RDS compared to neonates receiving nCPAP alone.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This study was a multicenter, randomized, controlled, open-label, dose-escalation study, conducted to evaluate the safety and tolerability of lucinactant for inhalation in conjunction with nasal continuous positive airway pressure (nCPAP) in comparison with nCPAP alone. The study was to evaluate the safety and tolerability of lucinactant for inhalation, administered as an aerosol in 4 escalating doses.
For this study, lucinactant for inhalation refers to the active investigational agent, lyophilized lucinactant, in combination with the prototype investigational delivery device. Reconstituted lyophilized lucinactant was aerosolized by the investigational device and introduced into the nCPAP circuit. Those randomized to the control arm continued to receive nCPAP alone. Dose assignments were unblinded, as the primary objective of this study was safety and tolerability.
Preterm neonates with respiratory distress syndrome (RDS) between 26 and 28 completed weeks PMA who were within the first 20 hours after birth and who had successful implementation of controlled nCPAP within 90 minutes of birth were considered to be potential subjects. Before study enrollment, legal guardians were provided a written informed consent form (ICF) for each potential subject.
Study Design
Study Type:
Interventional
Actual Enrollment
:
48 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Open-label, Controlled Trial To Assess The Safety And Tolerability Of Lucinactant For Inhalation In Preterm Neonates 26 to 28 Weeks PMA
Actual Study Start Date
:
Aug 1, 2015
Actual Primary Completion Date
:
May 31, 2017
Actual Study Completion Date
:
Aug 11, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 50 mg/kg Lucinactant for inhalation 50 mg total phospholipids (TPL)/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. |
Combination Product: Lucinactant for inhalation
Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
Other Names:
|
| Experimental: 75 mg/kg Lucinactant for inhalation 75 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. |
Combination Product: Lucinactant for inhalation
Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
Other Names:
|
| Experimental: 100 mg/kg Lucinactant for inhalation 100 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. |
Combination Product: Lucinactant for inhalation
Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
Other Names:
|
| Experimental: 150 mg/kg Lucinactant for inhalation 150 mg TPL/kg with nCPAP 1 repeat dose will be allowed if repeat dosing criteria are met. |
Combination Product: Lucinactant for inhalation
Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
Other Names:
|
| Active Comparator: nCPAP alone nCPAP therapy alone |
Device: nCPAP alone
nCPAP therapy
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Peri-Dosing Adverse Events - Initial Dose [Randomization to 24 Hours Post Randomization]
Number of Participants with adverse events that were experienced during the initial study treatment
- Number of Participants With Air Leak [7 days]
Number of participants with air leak (includes pneumothorax, pulmonary interstitial emphysema (PIE), pneumomediastinum, pneumopericardium, subcutaneous emphysema)
Secondary Outcome Measures
- Number of Participants With Worsening of Respiratory Status Criteria [Randomization to 72 Hours Post Randomization]
Number of participants with worsening in one of 12 respiratory status criteria through 72 hours post randomization (need for additional surfactant therapy, desaturation < 80%, heart rate < 100 bpm, sustained fraction of inspired oxygen (FiO2) > 0.50, arterial carbon dioxide (PCO2) > 65 mmHg, sustained apnea, persistent arterial pH < 7.2, intubation for any reason, nCPAP > 7 cmH2O, initiation of intermittent positive pressure ventilation, death, principal investigator determination of worsening status)
- Bronchopulmonary Dysplasia [Randomization to 36 weeks PMA]
Number of participants with bronchopulmonary dysplasia (BPD) and number of participants alive and without BPD at 36 weeks post-menstrual age (PMA)
- Number of Participants With Nasal Continuous Positive Airway Pressure (nCPAP) Failure [Randomization to 72 Hours Post Randomization]
Participants who required intubation for mechanical ventilation or surfactant administration were defined as having failed nCPAP
- Death [Randomization to 36 weeks PMA]
Number of participants who died during the study
- FiO2 [Randomization to 72 hours post randomization]
Observed and change from baseline measurements for fraction of inspired oxygen (FiO2). Values represent the amount (fraction) of oxygen in the air the participant inspires; the values themselves do not have units. The normal amount of oxygen in air ("room air") is 21%, or 0.21.
- Number of Participants With Complications of Prematurity [Randomization to 36 weeks PMA]
Number of participants with pre-specified common complications of prematurity.
Other Outcome Measures
- nCPAP Failure Without Treatment Interruptions [Randomization to 72 Hours Post Randomization]
Number of subjects requiring mechanical ventilation or surfactant administration (nCPAP failure) but did not have a treatment interruption
Eligibility Criteria
Criteria
Ages Eligible for Study:
26 Weeks
to 28 Weeks
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Informed consent from a legally authorized representative.
-
Gestational age 26 to 28 completed weeks post menstrual age (PMA).
-
Successful implementation of controlled nCPAP within 90 minutes after birth.
-
Spontaneous breathing.
-
Chest radiograph consistent with RDS.
-
Within the first 20 hours after birth, have an nCPAP of 5 to 6 cm H2O to maintain oxygen saturation measured by pulse oximetry (SpO2) of 88% to 95% with a fraction of inspired oxygen (FiO2) of 0.25 to 0.50 that is clinically indicated for at least 30 minutes. Transient (<10 minutes) FiO2 excursions below 0.25 or above 0.50 did not reset the 30 minute requirement.
Exclusion Criteria:
-
Heart rate that cannot be stabilized above 100 beats/minute within 5 minutes of birth.
-
Recurrent episodes of apnea occurring after the initial newborn resuscitation period (ie, 10 minutes after birth) requiring intermittent positive pressure breaths using inflating pressures above the set CPAP pressure administered manually or mechanically through any patient interface.
-
A 5 minute Apgar score < 5.
-
Major congenital malformation(s) and cranial/facial abnormalities that preclude nCPAP, diagnosed antenatally or immediately after birth.
-
Other diseases or conditions potentially interfering with cardiopulmonary function (eg, hydrops fetalis or congenital infection such as TORCH).
-
Known or suspected chromosomal abnormality or syndrome.
-
Premature rupture of membranes (PROM) > 2 weeks.
-
Evidence of hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis.
-
Need for endotracheal intubation and mechanical ventilation.
-
Has been administered: another investigational agent or investigational medical device, any other surfactant agent, steroid treatment after birth.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Loma Linda University Medical Center | Loma Linda | California | United States | 92354 |
| 2 | Sharp Mary Birch Hospital for Women and Newborns | San Diego | California | United States | 92123 |
| 3 | Christiana Care Health System | Newark | Delaware | United States | 19713 |
| 4 | University of Miami | Miami | Florida | United States | 33136 |
| 5 | University of Louisville | Louisville | Kentucky | United States | 40202 |
| 6 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68105 |
| 7 | Columbia University College of Physicians and Surgeons, New York Presbyterian Hospital - Morgan Stanley Children's Hospital | New York | New York | United States | 10032 |
| 8 | New Hanover Regional Medical Center | Wilmington | North Carolina | United States | 28401 |
| 9 | Providence St. Vincent Medical Center | Portland | Oregon | United States | 97225 |
| 10 | Women and Infants Hospital | Providence | Rhode Island | United States | 02905 |
| 11 | Foothills Medical Centre | Calgary | Alberta | Canada | T2N 2T9 |
| 12 | Royal Alexandria Hospital | Edmonton | Alberta | Canada | T5H 3V9 |
| 13 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 14 | Montreal Children's Hospital | Montreal | Quebec | Canada | H4A 3J1 |
| 15 | Hospital Dr Sotero Del Rio | Santiago | Chile | 8207257 | |
| 16 | Hospital San Juan de Dios | Santiago | Chile | 8350488 | |
| 17 | S.U. nr2im. Dr. Jana Biziela Oddzial Kliniczny N. W. Z. Intensywna Terapia Noworodka wraz z Wgjazdowy m Zespolem N | Bydgoszcz | Kujawsko-pomorksie | Poland | 85-168 |
| 18 | Instytut Centrum Zdrowja Matki Polki Klinika Neonatologii | Lodz | Lodzkie | Poland | 93-338 |
| 19 | Szpital Kliniczny im. Ks, Anny Mazowieckiej Klinika Neonatologii | Warsaw | Mazowieckie | Poland | 00-315 |
| 20 | Ginekologiczno-Polozniczy Szpital Klinicznym UM im. Karola Marcinkowskiego w Poznan i u Katedra Neonatologii | Poznan | Wielkopolskie | Poland | 60-535 |
Sponsors and Collaborators
- Windtree Therapeutics
Investigators
- Study Director: Steve Simonson, MD, Windtree Therapeutics
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Windtree Therapeutics
ClinicalTrials.gov Identifier:
NCT02528318
Other Study ID Numbers:
- 03-CL-1401
First Posted:
Aug 19, 2015
Last Update Posted:
Jul 23, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 50 mg/kg | 75 mg/kg | 100 mg/kg | 150 mg/kg | nCPAP Alone |
|---|---|---|---|---|---|
| Arm/Group Description | Lucinactant for inhalation 50 mg total phospholipids (TPL)/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 75 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 100 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 150 mg TPL/kg with nCPAP 1 repeat dose will be allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | nCPAP therapy alone nCPAP alone: nCPAP therapy |
| Period Title: Overall Study | |||||
| STARTED | 8 | 8 | 8 | 0 | 24 |
| COMPLETED | 8 | 8 | 8 | 0 | 24 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | 50 mg/kg | 75 mg/kg | 100 mg/kg | 150 mg/kg | nCPAP Alone | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Lucinactant for inhalation 50 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 75 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 100 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 150 mg TPL/kg with nCPAP 1 repeat dose will be allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | nCPAP therapy alone nCPAP alone: nCPAP therapy | Total of all reporting groups |
| Overall Participants | 8 | 8 | 8 | 0 | 24 | 48 |
| Age (Count of Participants) | ||||||
| <=18 years |
8
100%
|
8
100%
|
8
100%
|
0
NaN
|
24
100%
|
48
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
0%
|
0
0%
|
| Age, Customized (weeks) [Mean (Standard Deviation) ] | ||||||
| Gestational Age |
27.6
(0.61)
|
27.2
(1.06)
|
27.2
(0.84)
|
27.5
(0.76)
|
27.4
(0.84)
|
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
3
37.5%
|
5
62.5%
|
5
62.5%
|
8
Infinity
|
21
87.5%
|
|
| Male |
5
62.5%
|
3
37.5%
|
3
37.5%
|
16
Infinity
|
27
112.5%
|
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||
| Hispanic or Latino |
3
37.5%
|
1
12.5%
|
2
25%
|
7
Infinity
|
13
54.2%
|
|
| Not Hispanic or Latino |
5
62.5%
|
7
87.5%
|
6
75%
|
17
Infinity
|
35
145.8%
|
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
0%
|
|
| Race (NIH/OMB) (Count of Participants) | ||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
0%
|
|
| Asian |
2
25%
|
0
0%
|
1
12.5%
|
1
Infinity
|
4
16.7%
|
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
0%
|
|
| Black or African American |
1
12.5%
|
1
12.5%
|
2
25%
|
1
Infinity
|
5
20.8%
|
|
| White |
3
37.5%
|
5
62.5%
|
4
50%
|
20
Infinity
|
32
133.3%
|
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
0%
|
|
| Unknown or Not Reported |
2
25%
|
2
25%
|
1
12.5%
|
2
Infinity
|
7
29.2%
|
|
| Region of Enrollment (participants) [Number] | ||||||
| Canada |
1
12.5%
|
3
37.5%
|
4
50%
|
8
Infinity
|
16
66.7%
|
|
| United States |
7
87.5%
|
3
37.5%
|
4
50%
|
12
Infinity
|
26
108.3%
|
|
| Poland |
0
0%
|
2
25%
|
0
0%
|
3
Infinity
|
5
20.8%
|
|
| Chile |
0
0%
|
0
0%
|
0
0%
|
1
Infinity
|
1
4.2%
|
|
| Birth Weight (g) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [g] |
1052
(174.7)
|
855
(84.6)
|
839
(224.9)
|
1005
(238.8)
|
960
(209.4)
|
|
| Apgar Score at One Minute (Scores on a scale) [Mean (Full Range) ] | ||||||
| Mean (Full Range) [Scores on a scale] |
5.4
|
5.5
|
6.4
|
5.8
|
5.8
|
|
| Apgar Score at Five Minutes (Scores on a scale) [Mean (Full Range) ] | ||||||
| Mean (Full Range) [Scores on a scale] |
7.8
|
6.4
|
8.1
|
7.9
|
7.7
|
|
Outcome Measures
| Title | Number of Participants With Peri-Dosing Adverse Events - Initial Dose |
|---|---|
| Description | Number of Participants with adverse events that were experienced during the initial study treatment |
| Time Frame | Randomization to 24 Hours Post Randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Peri-dosing events are events that occur during study treatment. Since this was an open-label study, no peri-dosing events were recorded for nCPAP alone. Any adverse events that occurred during the corresponding time for nCPAP alone were recorded as adverse events but not peri-dosing events. |
| Arm/Group Title | 50 mg/kg | 75 mg/kg | 100 mg/kg | 150 mg/kg | nCPAP Alone |
|---|---|---|---|---|---|
| Arm/Group Description | Lucinactant for inhalation 50 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 75 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 100 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 150 mg TPL/kg with nCPAP 1 repeat dose will be allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | nCPAP therapy alone nCPAP alone: nCPAP therapy |
| Measure Participants | 8 | 8 | 8 | 0 | 0 |
| Bradycardia |
0
0%
|
2
25%
|
1
12.5%
|
||
| Desaturation |
1
12.5%
|
2
25%
|
3
37.5%
|
||
| Gagging/regurgitation |
0
0%
|
0
0%
|
0
0%
|
||
| Apnea |
1
12.5%
|
1
12.5%
|
1
12.5%
|
||
| Pallor |
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Air Leak |
|---|---|
| Description | Number of participants with air leak (includes pneumothorax, pulmonary interstitial emphysema (PIE), pneumomediastinum, pneumopericardium, subcutaneous emphysema) |
| Time Frame | 7 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg. |
| Arm/Group Title | 50 mg/kg | 75 mg/kg | 100 mg/kg | 150 mg/kg | nCPAP Alone |
|---|---|---|---|---|---|
| Arm/Group Description | Lucinactant for inhalation 50 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 75 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 100 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 150 mg TPL/kg with nCPAP 1 repeat dose will be allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | nCPAP therapy alone nCPAP alone: nCPAP therapy |
| Measure Participants | 8 | 8 | 8 | 0 | 24 |
| Count of Participants [Participants] |
3
37.5%
|
0
0%
|
2
25%
|
4
Infinity
|
| Title | Number of Participants With Worsening of Respiratory Status Criteria |
|---|---|
| Description | Number of participants with worsening in one of 12 respiratory status criteria through 72 hours post randomization (need for additional surfactant therapy, desaturation < 80%, heart rate < 100 bpm, sustained fraction of inspired oxygen (FiO2) > 0.50, arterial carbon dioxide (PCO2) > 65 mmHg, sustained apnea, persistent arterial pH < 7.2, intubation for any reason, nCPAP > 7 cmH2O, initiation of intermittent positive pressure ventilation, death, principal investigator determination of worsening status) |
| Time Frame | Randomization to 72 Hours Post Randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat Population |
| Arm/Group Title | 50 mg/kg | 75 mg/kg | 100 mg/kg | 150 mg/kg | nCPAP Alone |
|---|---|---|---|---|---|
| Arm/Group Description | Lucinactant for inhalation 50 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 75 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 100 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 150 mg TPL/kg with nCPAP 1 repeat dose will be allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | nCPAP therapy alone nCPAP alone: nCPAP therapy |
| Measure Participants | 8 | 8 | 8 | 0 | 24 |
| Count of Participants [Participants] |
6
75%
|
7
87.5%
|
6
75%
|
18
Infinity
|
| Title | Bronchopulmonary Dysplasia |
|---|---|
| Description | Number of participants with bronchopulmonary dysplasia (BPD) and number of participants alive and without BPD at 36 weeks post-menstrual age (PMA) |
| Time Frame | Randomization to 36 weeks PMA |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat Population |
| Arm/Group Title | 50 mg/kg | 75 mg/kg | 100 mg/kg | 150 mg/kg | nCPAP Alone |
|---|---|---|---|---|---|
| Arm/Group Description | Lucinactant for inhalation 50 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 75 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 100 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 150 mg TPL/kg with nCPAP 1 repeat dose will be allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | nCPAP therapy alone nCPAP alone: nCPAP therapy |
| Measure Participants | 8 | 8 | 8 | 0 | 24 |
| BPD |
0
0%
|
0
0%
|
0
0%
|
6
Infinity
|
|
| Alive and Without BPD |
7
87.5%
|
7
87.5%
|
8
100%
|
18
Infinity
|
| Title | Number of Participants With Nasal Continuous Positive Airway Pressure (nCPAP) Failure |
|---|---|
| Description | Participants who required intubation for mechanical ventilation or surfactant administration were defined as having failed nCPAP |
| Time Frame | Randomization to 72 Hours Post Randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat Population |
| Arm/Group Title | 50 mg/kg | 75 mg/kg | 100 mg/kg | 150 mg/kg | nCPAP Alone |
|---|---|---|---|---|---|
| Arm/Group Description | Lucinactant for inhalation 50 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 75 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 100 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 150 mg TPL/kg with nCPAP 1 repeat dose will be allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | nCPAP therapy alone nCPAP alone: nCPAP therapy |
| Measure Participants | 8 | 8 | 8 | 0 | 24 |
| Count of Participants [Participants] |
5
62.5%
|
7
87.5%
|
5
62.5%
|
16
Infinity
|
| Title | Death |
|---|---|
| Description | Number of participants who died during the study |
| Time Frame | Randomization to 36 weeks PMA |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | 50 mg/kg | 75 mg/kg | 100 mg/kg | 150 mg/kg | nCPAP Alone |
|---|---|---|---|---|---|
| Arm/Group Description | Lucinactant for inhalation 50 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 75 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 100 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 150 mg TPL/kg with nCPAP 1 repeat dose will be allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | nCPAP therapy alone nCPAP alone: nCPAP therapy |
| Measure Participants | 8 | 8 | 8 | 0 | 24 |
| Count of Participants [Participants] |
1
12.5%
|
1
12.5%
|
0
0%
|
0
NaN
|
0
0%
|
| Title | FiO2 |
|---|---|
| Description | Observed and change from baseline measurements for fraction of inspired oxygen (FiO2). Values represent the amount (fraction) of oxygen in the air the participant inspires; the values themselves do not have units. The normal amount of oxygen in air ("room air") is 21%, or 0.21. |
| Time Frame | Randomization to 72 hours post randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | 50 mg/kg | 75 mg/kg | 100 mg/kg | 150 mg/kg | nCPAP Alone |
|---|---|---|---|---|---|
| Arm/Group Description | Lucinactant for inhalation 50 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 75 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 100 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 150 mg TPL/kg with nCPAP 1 repeat dose will be allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | nCPAP therapy alone nCPAP alone: nCPAP therapy |
| Measure Participants | 8 | 8 | 8 | 0 | 24 |
| Baseline (Randomization) |
0.31
(0.058)
|
0.33
(0.071)
|
0.37
(0.072)
|
0.32
(0.061)
|
|
| 60 Minutes Post Randomization - Observed |
0.31
(0.064)
|
0.35
(0.063)
|
0.37
(0.090)
|
0.34
(0.159)
|
|
| 60 Minutes Post Randomizati - Change from Baseline |
0.01
(0.010)
|
0.02
(0.024)
|
0.01
(0.044)
|
0.01
(0.162)
|
|
| 3 Hours Post Randomization - Observed |
0.37
(0.191)
|
0.37
(0.120)
|
0.37
(0.107)
|
0.29
(0.082)
|
|
| 3 Hours Post Randomizaiton - Change from Baseline |
0.06
(0.154)
|
0.00
(0.066)
|
0.00
(0.047)
|
-0.03
(0.082)
|
|
| 12 Hours Post Randomization - Observed |
0.30
(0.114)
|
0.30
(0.117)
|
0.30
(0.068)
|
0.33
(0.181)
|
|
| 12 Hours Post Randomization - Change from Baseline |
-0.02
(0.137)
|
-0.07
(0.074)
|
-0.08
(0.090)
|
0.00
(0.172)
|
|
| 24 Hours Post Randomized - Observed |
0.28
(0.093)
|
0.25
(0.044)
|
0.28
(0.077)
|
0.29
(0.143)
|
|
| 24 Hours Post Randomized - Change from Baseline |
-0.03
(0.072)
|
-0.09
(0.046)
|
-0.08
(0.105)
|
-0.04
(0.140)
|
|
| 48 Hours Post Randomized - Observed |
0.28
(0.058)
|
0.24
(0.038)
|
0.29
(0.071)
|
0.31
(0.188)
|
|
| 48 Hours Post Randomized - Change from Baseline |
-0.03
(0.083)
|
-0.09
(0.075)
|
-0.09
(0.091)
|
-0.02
(0.191)
|
|
| 72 Hours Post Randomized - Observed |
0.30
(0.105)
|
0.23
(0.023)
|
0.25
(0.050)
|
0.27
(0.119)
|
|
| 72 Hours Post Randomized - Change from Baseline |
-0.02
(0.133)
|
-0.10
(0.071)
|
-0.12
(0.066)
|
-0.05
(0.133)
|
| Title | Number of Participants With Complications of Prematurity |
|---|---|
| Description | Number of participants with pre-specified common complications of prematurity. |
| Time Frame | Randomization to 36 weeks PMA |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | 50 mg/kg | 75 mg/kg | 100 mg/kg | 150 mg/kg | nCPAP Alone |
|---|---|---|---|---|---|
| Arm/Group Description | Lucinactant for inhalation 50 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 75 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 100 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 150 mg TPL/kg with nCPAP 1 repeat dose will be allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | nCPAP therapy alone nCPAP alone: nCPAP therapy |
| Measure Participants | 8 | 8 | 8 | 0 | 24 |
| Subjects with Any Complication |
8
100%
|
7
87.5%
|
7
87.5%
|
22
Infinity
|
|
| Acquired Sepsis |
2
25%
|
2
25%
|
2
25%
|
5
Infinity
|
|
| Apnea |
8
100%
|
5
62.5%
|
6
75%
|
19
Infinity
|
|
| Cystic Periventricular Leukomalcia |
0
0%
|
0
0%
|
0
0%
|
1
Infinity
|
|
| Patent Ductus Arteriosus |
3
37.5%
|
3
37.5%
|
4
50%
|
10
Infinity
|
|
| Pulmonary Hemorrhage |
1
12.5%
|
0
0%
|
1
12.5%
|
1
Infinity
|
|
| Intraventicular Hemorrhage |
0
0%
|
1
12.5%
|
3
37.5%
|
4
Infinity
|
|
| Necrotizing Enterocolitis |
1
12.5%
|
1
12.5%
|
1
12.5%
|
1
Infinity
|
|
| Retinopathy of Prematurity |
2
25%
|
1
12.5%
|
1
12.5%
|
9
Infinity
|
| Title | nCPAP Failure Without Treatment Interruptions |
|---|---|
| Description | Number of subjects requiring mechanical ventilation or surfactant administration (nCPAP failure) but did not have a treatment interruption |
| Time Frame | Randomization to 72 Hours Post Randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat Without Treatment Interruption |
| Arm/Group Title | 50 mg/kg | 75 mg/kg | 100 mg/kg | 150 mg/kg | nCPAP Alone |
|---|---|---|---|---|---|
| Arm/Group Description | Lucinactant for inhalation 50 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 75 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 100 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 150 mg TPL/kg with nCPAP 1 repeat dose will be allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | nCPAP therapy alone nCPAP alone: nCPAP therapy |
| Measure Participants | 7 | 3 | 6 | 0 | 24 |
| Count of Participants [Participants] |
4
50%
|
3
37.5%
|
3
37.5%
|
16
Infinity
|
Adverse Events
| Time Frame | From randomization to 36 weeks PMA | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg. | |||||||||
| Arm/Group Title | 50 mg/kg | 75 mg/kg | 100 mg/kg | 150 mg/kg | nCPAP Alone | |||||
| Arm/Group Description | Lucinactant for inhalation 50 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 75 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 100 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | Lucinactant for inhalation 150 mg TPL/kg with nCPAP 1 repeat dose will be allowed if repeat dosing criteria are met. Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) | nCPAP therapy alone nCPAP alone: nCPAP therapy | |||||
All Cause Mortality |
||||||||||
| 50 mg/kg | 75 mg/kg | 100 mg/kg | 150 mg/kg | nCPAP Alone | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/8 (12.5%) | 1/8 (12.5%) | 0/8 (0%) | 0/0 (NaN) | 0/24 (0%) | |||||
Serious Adverse Events |
||||||||||
| 50 mg/kg | 75 mg/kg | 100 mg/kg | 150 mg/kg | nCPAP Alone | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/8 (50%) | 3/8 (37.5%) | 2/8 (25%) | 0/0 (NaN) | 6/24 (25%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia neonatal | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/0 (NaN) | 1/24 (4.2%) | 1 | ||||
| Cardiac disorders | ||||||||||
| Cardiac arrest | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/0 (NaN) | 1/24 (4.2%) | 1 | ||||
| Cardio-respiratory arrest | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/0 (NaN) | 1/24 (4.2%) | 1 | ||||
| Gastrointestinal disorders | ||||||||||
| Gastric perforation | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/0 (NaN) | 1/24 (4.2%) | 1 | ||||
| Intestinal perforation | 1/8 (12.5%) | 1 | 0/8 (0%) | 1 | 0/8 (0%) | 1 | 0/0 (NaN) | 1 | 1/24 (4.2%) | 1 |
| Pneumoperitoneum | 0/8 (0%) | 1/8 (12.5%) | 1 | 0/8 (0%) | 1 | 0/0 (NaN) | 1 | 0/24 (0%) | 1 | |
| Infections and infestations | ||||||||||
| Pneumonia | 0/8 (0%) | 1/8 (12.5%) | 1 | 0/8 (0%) | 1 | 0/0 (NaN) | 1 | 1/24 (4.2%) | 1 | |
| Sepsis neonatal | 1/8 (12.5%) | 1 | 0/8 (0%) | 1 | 0/8 (0%) | 1 | 0/0 (NaN) | 1 | 0/24 (0%) | 1 |
| Injury, poisoning and procedural complications | ||||||||||
| Hepatic haemorrhage | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/0 (NaN) | 1/24 (4.2%) | 1 | ||||
| Laryngeal injury | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/0 (NaN) | 1/24 (4.2%) | 1 | ||||
| Traumatic liver injury | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/0 (NaN) | 1/24 (4.2%) | 1 | ||||
| Pregnancy, puerperium and perinatal conditions | ||||||||||
| Intraventricular haemorrhage neonatal | 0/8 (0%) | 0/8 (0%) | 2/8 (25%) | 2 | 0/0 (NaN) | 2 | 1/24 (4.2%) | 1 | ||
| Necrotising enterocolitis neonatal | 1/8 (12.5%) | 1 | 0/8 (0%) | 1 | 0/8 (0%) | 1 | 0/0 (NaN) | 1 | 1/24 (4.2%) | 1 |
| Neonatal respiratory distress syndrome | 0/8 (0%) | 2/8 (25%) | 2 | 0/8 (0%) | 2 | 0/0 (NaN) | 2 | 1/24 (4.2%) | 1 | |
| Neonatal respiratory failure | 0/8 (0%) | 1/8 (12.5%) | 1 | 0/8 (0%) | 1 | 0/0 (NaN) | 1 | 0/24 (0%) | 1 | |
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Apnoea neonatal | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/0 (NaN) | 1/24 (4.2%) | 1 | ||||
| Neonatal respiratory failure | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/0 (NaN) | 1/24 (4.2%) | 1 | ||||
| Pneumothorax | 1/8 (12.5%) | 1 | 0/8 (0%) | 1 | 1/8 (12.5%) | 1 | 0/0 (NaN) | 1 | 2/24 (8.3%) | 2 |
| Vascular disorders | ||||||||||
| Shock | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/0 (NaN) | 1/24 (4.2%) | 1 | ||||
Other (Not Including Serious) Adverse Events |
||||||||||
| 50 mg/kg | 75 mg/kg | 100 mg/kg | 150 mg/kg | nCPAP Alone | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/8 (100%) | 8/8 (100%) | 8/8 (100%) | 0/0 (NaN) | 24/24 (100%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia neonatal | 6/8 (75%) | 6 | 4/8 (50%) | 6 | 2/8 (25%) | 2 | 0/0 (NaN) | 0 | 12/24 (50%) | 16 |
| Bandaemia | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Coagulopathy | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Leukocytosis | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Leukopenia | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 2/24 (8.3%) | 2 |
| Neutropenia | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Thrombocytopenia | 2/8 (25%) | 2 | 2/8 (25%) | 2 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 4/24 (16.7%) | 4 |
| Thrombocytosis | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Cardiac disorders | ||||||||||
| Arrhythmia | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Tachycardia | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 1 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||||||||
| Atrial septal defect | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 1 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Cardiac septal defect | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Hydrocele | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Patent ductus arteriosus | 3/8 (37.5%) | 3 | 3/8 (37.5%) | 3 | 4/8 (50%) | 4 | 0/0 (NaN) | 0 | 10/24 (41.7%) | 10 |
| Endocrine disorders | ||||||||||
| Adrenal insufficiency | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Gastrointestinal disorders | ||||||||||
| Abdominal distension | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Abdominal pain | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Constipation | 5/8 (62.5%) | 13 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/0 (NaN) | 0 | 2/24 (8.3%) | 2 |
| Gastric haemorrhage | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Gastric hypomotility | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Gastrointestinal hypomotility | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Gastrooesophageal reflux disease | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Haematemesis | 2/8 (25%) | 2 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Inguinal hernia | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 2/24 (8.3%) | 2 |
| Salivary hypersection | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Umbilical hernia | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 1 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Vomiting | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| General disorders | ||||||||||
| Endotracheal intubation complication | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Face oedema | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Hypothermia | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 2/24 (8.3%) | 2 |
| Oedema | 3/8 (37.5%) | 3 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Pain | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Pyrexia | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Hepatobiliary disorders | ||||||||||
| Cholestasis | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 3/24 (12.5%) | 3 |
| Gallbladder disorder | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Infections and infestations | ||||||||||
| Bacteraemia | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Bacterial disease carrier | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 2/8 (25%) | 2 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Conjunctivitis | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Enterococcal sepsis | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Fungal skin infection | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Nosocomial infection | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Pneumonia | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 3/24 (12.5%) | 3 |
| Pneumonia klebsiella | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Pneumonia staphylococcal | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Sepsis neonatal | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 1 | 0/0 (NaN) | 0 | 4/24 (16.7%) | 4 |
| Septic shock | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Urinary tract infection | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 2 |
| Urinary tract infection enterococcal | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Urosepsis | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||
| Blister | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Ear abrasion | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Infusion site extravasation | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Laceration | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Skin abrasion | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Tracheal injury | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Investigations | ||||||||||
| Anticonvulsant drug level above therapeutic level | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Blood urea increased | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Cardiac murmur | 2/8 (25%) | 2 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Coagulation time prolonged | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Neutrophil count increased | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Oxygen saturation decreased | 2/8 (25%) | 3 | 4/8 (50%) | 6 | 6/8 (75%) | 11 | 0/0 (NaN) | 0 | 9/24 (37.5%) | 11 |
| PO2 increased | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Reticulocyte count increased | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Metabolism and nutrition disorders | ||||||||||
| Dehydration | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Electrolyte imbalance | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Feeding intolerance | 3/8 (37.5%) | 3 | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 1 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Fluid retention | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Hypercalcaemia | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Hyperchloraemia | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 3/24 (12.5%) | 3 |
| Hyperglycaemia | 1/8 (12.5%) | 1 | 2/8 (25%) | 2 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 3/24 (12.5%) | 5 |
| Hyperkalaemia | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 2/24 (8.3%) | 2 |
| Hypermagnesaemia | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Hypernatraemia | 1/8 (12.5%) | 1 | 2/8 (25%) | 2 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 4/24 (16.7%) | 5 |
| Hypertriglyceridaemia | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 2/24 (8.3%) | 3 |
| Hypoalbuminaemia | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 3/24 (12.5%) | 3 |
| Hypocalcaemia | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 2/24 (8.3%) | 2 |
| Hypochloraemia | 2/8 (25%) | 2 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 3/24 (12.5%) | 4 |
| Hypoglycaemia | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 3/24 (12.5%) | 3 |
| Hypokalaemia | 0/8 (0%) | 0 | 2/8 (25%) | 2 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 3/24 (12.5%) | 4 |
| Hypomagnesaemia | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Hyponatraemia | 3/8 (37.5%) | 3 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 7/24 (29.2%) | 7 |
| Hypophosphataemia | 2/8 (25%) | 2 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Hypovolaemia | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Metabolic acidosis | 3/8 (37.5%) | 3 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 5/24 (20.8%) | 5 |
| Metabolic alkalosis | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Osteopenia | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 2/24 (8.3%) | 2 |
| Vitamin D deficiency | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Nervous system disorders | ||||||||||
| Hypotonia | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Lethargy | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Periventricular leukomalacia | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Seizure | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 2 |
| Pregnancy, puerperium and perinatal conditions | ||||||||||
| Agitation neonatal | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Bradycardia neonatal | 0/8 (0%) | 0 | 5/8 (62.5%) | 7 | 3/8 (37.5%) | 5 | 0/0 (NaN) | 0 | 9/24 (37.5%) | 9 |
| Fixed bowel loop | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Intraventricular haemorrhage neonatal | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 1 | 0/0 (NaN) | 0 | 2/24 (8.3%) | 2 |
| Jaundice neonatal | 5/8 (62.5%) | 5 | 3/8 (37.5%) | 3 | 1/8 (12.5%) | 1 | 0/0 (NaN) | 0 | 11/24 (45.8%) | 12 |
| Necrotising enterocolitis neonatal | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 1 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Neonatal respiratory distress syndrome | 1/8 (12.5%) | 1 | 2/8 (25%) | 2 | 2/8 (25%) | 3 | 0/0 (NaN) | 0 | 9/24 (37.5%) | 12 |
| Periventricular haemorrhage neonatal | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Retinopathy of prematurity | 2/8 (25%) | 2 | 1/8 (12.5%) | 1 | 1/8 (12.5%) | 1 | 0/0 (NaN) | 0 | 9/24 (37.5%) | 9 |
| Small for dates baby | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Renal and urinary disorders | ||||||||||
| Azotaemia | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Haematuria | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Oliguria | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 2/24 (8.3%) | 2 |
| Renal failure | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 2/24 (8.3%) | 3 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Apnoea neonatal | 7/8 (87.5%) | 7 | 4/8 (50%) | 5 | 6/8 (75%) | 9 | 0/0 (NaN) | 0 | 19/24 (79.2%) | 21 |
| Bronchopulmonary dysplasia | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 7/24 (29.2%) | 8 |
| Chronic respiratory failure | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Hypercapnia | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 2/24 (8.3%) | 4 |
| Nasal discomfort | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Nasal inflammation | 2/8 (25%) | 3 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 2/24 (8.3%) | 2 |
| Nasal mucosal ulcer | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Neonatal respiratory failure | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Neonatal tachypnoea | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/0 (NaN) | 0 | 2/24 (8.3%) | 3 |
| Pneumothorax | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Pulmonary haemorrhage | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Pulmonary hypertension | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Pulmonary interstitial emphysema syndrome | 3/8 (37.5%) | 3 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/0 (NaN) | 0 | 3/24 (12.5%) | 3 |
| Pulmonary oedema neonatal | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 2/24 (8.3%) | 2 |
| Respiratory acidosis | 2/8 (25%) | 2 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 2 |
| Respiratory alkalosis | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 2 |
| Respiratory tract haemorrhage | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/0 (NaN) | 0 | 0/24 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||
| Dermatitis diaper | 4/8 (50%) | 5 | 2/8 (25%) | 2 | 1/8 (12.5%) | 1 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Rash | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 2/24 (8.3%) | 2 |
| Vascular disorders | ||||||||||
| Haemangioma | 0/8 (0%) | 0 | 1/8 (12.5%) | 1 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Hypertension | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 1/24 (4.2%) | 1 |
| Hypotension | 1/8 (12.5%) | 1 | 2/8 (25%) | 2 | 0/8 (0%) | 0 | 0/0 (NaN) | 0 | 4/24 (16.7%) | 7 |
Limitations/Caveats
The study was terminated prior to subject enrollment for the 150 mg TPL/kg dose by the sponsor for administrative reasons.
The overall results may have been impacted by treatment interruptions caused by clogging of study drug.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The preparation and submittal for publication of a manuscript containing the study results shall be in accordance with a process determined by a mutual written agreement among Windtree Therapeutics, Inc. and participating institutions. The publication or presentation of any study results shall comply with all applicable privacy laws, including, but not limited to, HIPAA.
Results Point of Contact
| Name/Title | Robert Segal, MD, FACP |
|---|---|
| Organization | Windtree Therapeutics, Inc. |
| Phone | 215-488-9300 ext 9450 |
| rsegal@windtreetx.com |
Responsible Party:
Windtree Therapeutics
ClinicalTrials.gov Identifier:
NCT02528318
Other Study ID Numbers:
- 03-CL-1401
First Posted:
Aug 19, 2015
Last Update Posted:
Jul 23, 2019
Last Verified:
Jul 1, 2019