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Sponsor decision to terminate after 3 dosing groups
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50 mg/kg | Experimental | Lucinactant for inhalation 50 mg total phospholipids (TPL)/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. |
|
| 75 mg/kg | Experimental | Lucinactant for inhalation 75 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. |
|
| 100 mg/kg | Experimental | Lucinactant for inhalation 100 mg TPL/kg with nCPAP 1 repeat dose allowed if repeat dosing criteria are met. |
|
| 150 mg/kg | Experimental | Lucinactant for inhalation 150 mg TPL/kg with nCPAP 1 repeat dose will be allowed if repeat dosing criteria are met. |
|
| nCPAP alone | Active Comparator | nCPAP therapy alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lucinactant for inhalation | Combination Product | Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Peri-Dosing Adverse Events - Initial Dose | Number of Participants with adverse events that were experienced during the initial study treatment | Randomization to 24 Hours Post Randomization |
| Number of Participants With Air Leak | Number of participants with air leak (includes pneumothorax, pulmonary interstitial emphysema (PIE), pneumomediastinum, pneumopericardium, subcutaneous emphysema) | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Worsening of Respiratory Status Criteria | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| nCPAP Failure Without Treatment Interruptions | Number of subjects requiring mechanical ventilation or surfactant administration (nCPAP failure) but did not have a treatment interruption | Randomization to 72 Hours Post Randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Simonson, MD | Windtree Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States | ||
| Sharp Mary Birch Hospital for Women and Newborns |
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| ID | Title | Description |
|---|---|---|
| FG000 | 50 mg/kg | 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) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 13, 2015 | Apr 26, 2018 |
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|
| nCPAP alone | Device | nCPAP therapy |
|
|
| Randomization to 72 Hours Post Randomization |
| Bronchopulmonary Dysplasia | Number of participants with bronchopulmonary dysplasia (BPD) and number of participants alive and without BPD at 36 weeks post-menstrual age (PMA) | Randomization to 36 weeks PMA |
| Number of Participants With Nasal Continuous Positive Airway Pressure (nCPAP) Failure | Participants who required intubation for mechanical ventilation or surfactant administration were defined as having failed nCPAP | Randomization to 72 Hours Post Randomization |
| Death | Number of participants who died during the study | Randomization to 36 weeks PMA |
| FiO2 | 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. | Randomization to 72 hours post randomization |
| Number of Participants With Complications of Prematurity | Number of participants with pre-specified common complications of prematurity. | Randomization to 36 weeks PMA |
| San Diego |
| California |
| 92123 |
| United States |
| Christiana Care Health System | Newark | Delaware | 19713 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68105 | United States |
| Columbia University College of Physicians and Surgeons, New York Presbyterian Hospital - Morgan Stanley Children's Hospital | New York | New York | 10032 | United States |
| New Hanover Regional Medical Center | Wilmington | North Carolina | 28401 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Women and Infants Hospital | Providence | Rhode Island | 02905 | United States |
| Foothills Medical Centre | Calgary | Alberta | T2N 2T9 | Canada |
| Royal Alexandria Hospital | Edmonton | Alberta | T5H 3V9 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Montreal Children's Hospital | Montreal | Quebec | H4A 3J1 | Canada |
| Hospital Dr Sotero Del Rio | Santiago | 8207257 | Chile |
| Hospital San Juan de Dios | Santiago | 8350488 | Chile |
| Ginekologiczno-Polozniczy Szpital Klinicznym UM im. Karola Marcinkowskiego w Poznan i u Katedra Neonatologii | Poznan | Greater Poland Voivodeship | 60-535 | Poland |
| S.U. nr2im. Dr. Jana Biziela Oddzial Kliniczny N. W. Z. Intensywna Terapia Noworodka wraz z Wgjazdowy m Zespolem N | Bydgoszcz | Kujawsko-pomorksie | 85-168 | Poland |
| Szpital Kliniczny im. Ks, Anny Mazowieckiej Klinika Neonatologii | Warsaw | Masovian Voivodeship | 00-315 | Poland |
| Instytut Centrum Zdrowja Matki Polki Klinika Neonatologii | Lodz | Łódź Voivodeship | 93-338 | Poland |
| FG001 |
| 75 mg/kg |
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) |
| FG002 | 100 mg/kg | 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) |
| FG003 | 150 mg/kg | 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) |
| FG004 | nCPAP Alone | nCPAP therapy alone nCPAP alone: nCPAP therapy |
| COMPLETED |
|
| NOT COMPLETED |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 50 mg/kg | 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) |
| BG001 | 75 mg/kg | 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) |
| BG002 | 100 mg/kg | 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) |
| BG003 | 150 mg/kg | 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) |
| BG004 | nCPAP Alone | nCPAP therapy alone nCPAP alone: nCPAP therapy |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Customized | Gestational age, based on obstetrician's best estimate | Mean | Standard Deviation | weeks |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Birth Weight | Mean | Standard Deviation | g |
| |||||||||||||||
| Apgar Score at One Minute | The Apgar Score measures a baby's health by assessing five characteristics (Appearance, Pulse, Grimace, Activity, and Respiration) . Each of the five characteristics are scored from 0 to 2, and the five scores are summed for the Apgar Score. Thus, the Apgar Score ranges from 0 (worst) to 10 (best), and scores over 7 indicate a baby in good health. Apgar Scores are performed at 1 minute and 5 minutes after birth. | Mean | Full Range | Scores on a scale |
| ||||||||||||||
| Apgar Score at Five Minutes | The Apgar Score measures a baby's health by assessing five characteristics (Appearance, Pulse, Grimace, Activity, and Respiration) . Each of the five characteristics are scored from 0 to 2, and the five scores are summed for the Apgar Score. Thus, the Apgar Score ranges from 0 (worst) to 10 (best), and scores over 7 indicate a baby in good health. Apgar Scores are performed at 1 minute and 5 minutes after birth. | Mean | Full Range | Scores on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Peri-Dosing Adverse Events - Initial Dose | Number of Participants with adverse events that were experienced during the initial study treatment | 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. | Posted | Count of Participants | Participants | Randomization to 24 Hours Post Randomization |
|
|
| |||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Air Leak | Number of participants with air leak (includes pneumothorax, pulmonary interstitial emphysema (PIE), pneumomediastinum, pneumopericardium, subcutaneous emphysema) | 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. | Posted | Count of Participants | Participants | 7 days |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Worsening of Respiratory Status Criteria | 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) | Intent-to-Treat Population | Posted | Count of Participants | Participants | Randomization to 72 Hours Post Randomization |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Bronchopulmonary Dysplasia | Number of participants with bronchopulmonary dysplasia (BPD) and number of participants alive and without BPD at 36 weeks post-menstrual age (PMA) | Intent-to-Treat Population | Posted | Count of Participants | Participants | Randomization to 36 weeks PMA |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Nasal Continuous Positive Airway Pressure (nCPAP) Failure | Participants who required intubation for mechanical ventilation or surfactant administration were defined as having failed nCPAP | Intent-to-Treat Population | Posted | Count of Participants | Participants | Randomization to 72 Hours Post Randomization |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Death | Number of participants who died during the study | Safety Population | Posted | Count of Participants | Participants | Randomization to 36 weeks PMA |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | FiO2 | 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. | Safety Population | Posted | Mean | Standard Deviation | Fraction of oxygen in inspired air | Randomization to 72 hours post randomization |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Complications of Prematurity | Number of participants with pre-specified common complications of prematurity. | Safety Population | Posted | Count of Participants | Participants | Randomization to 36 weeks PMA |
| |||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | nCPAP Failure Without Treatment Interruptions | Number of subjects requiring mechanical ventilation or surfactant administration (nCPAP failure) but did not have a treatment interruption | Intent-to-Treat Without Treatment Interruption | Posted | Count of Participants | Participants | Randomization to 72 Hours Post Randomization |
|
From randomization to 36 weeks PMA
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 50 mg/kg | 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) | 1 | 8 | 4 | 8 | 8 | 8 |
| EG001 | 75 mg/kg | 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) | 1 | 8 | 3 | 8 | 8 | 8 |
| EG002 | 100 mg/kg | 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) | 0 | 8 | 2 | 8 | 8 | 8 |
| EG003 | 150 mg/kg | 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) | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | nCPAP Alone | nCPAP therapy alone nCPAP alone: nCPAP therapy | 0 | 24 | 6 | 24 | 24 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia neonatal | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Sepsis neonatal | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hepatic haemorrhage | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Laryngeal injury | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment | Laryngeal trauma due to intubation |
|
| Traumatic liver injury | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment | Liver laceration |
|
| Intraventricular haemorrhage neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA (18.1) | Non-systematic Assessment |
| |
| Necrotising enterocolitis neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA (18.1) | Non-systematic Assessment |
| |
| Neonatal respiratory distress syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA (18.1) | Non-systematic Assessment |
| |
| Neonatal respiratory failure | Pregnancy, puerperium and perinatal conditions | MedDRA (18.1) | Non-systematic Assessment |
| |
| Apnoea neonatal | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Neonatal respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment | Refractory shock |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia neonatal | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Bandaemia | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cardiac septal defect | Congenital, familial and genetic disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Patent ductus arteriosus | Congenital, familial and genetic disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Gastric hypomotility | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Gastrointestinal hypomotility | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Salivary hypersection | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Endotracheal intubation complication | General disorders | MedDRA (18.1) | Non-systematic Assessment | Inadvertent extubation |
|
| Face oedema | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Gallbladder disorder | Hepatobiliary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Bacterial disease carrier | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment | Methicillin-sensitive S. aureus (MSSA) colonization |
|
| Conjunctivitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Nosocomial infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Sepsis neonatal | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Blister | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Ear abrasion | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Infusion site extravasation | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment | Peripheral IV infiltration |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Tracheal injury | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Anticonvulsant drug level above therapeutic level | Investigations | MedDRA (18.1) | Non-systematic Assessment | Increased levels of phenobarbital |
|
| Blood urea increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Coagulation time prolonged | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| PO2 increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Reticulocyte count increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Feeding intolerance | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hyperchloraemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Metabolic alkalosis | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Osteopenia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Periventricular leukomalacia | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Agitation neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA (18.1) | Non-systematic Assessment |
| |
| Bradycardia neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA (18.1) | Non-systematic Assessment |
| |
| Fixed bowel loop | Pregnancy, puerperium and perinatal conditions | MedDRA (18.1) | Non-systematic Assessment |
| |
| Intraventricular haemorrhage neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA (18.1) | Non-systematic Assessment |
| |
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA (18.1) | Non-systematic Assessment |
| |
| Necrotising enterocolitis neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA (18.1) | Non-systematic Assessment |
| |
| Neonatal respiratory distress syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA (18.1) | Non-systematic Assessment |
| |
| Periventricular haemorrhage neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA (18.1) | Non-systematic Assessment |
| |
| Retinopathy of prematurity | Pregnancy, puerperium and perinatal conditions | MedDRA (18.1) | Non-systematic Assessment |
| |
| Small for dates baby | Pregnancy, puerperium and perinatal conditions | MedDRA (18.1) | Non-systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Apnoea neonatal | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Nasal mucosal ulcer | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Neonatal respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Neonatal tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pulmonary interstitial emphysema syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pulmonary oedema neonatal | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Respiratory alkalosis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Haemangioma | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
|
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.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Segal, MD, FACP | Windtree Therapeutics, Inc. | 215-488-9300 | 9450 | rsegal@windtreetx.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 2, 2015 | Apr 26, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C502722 | lucinactant |
| D001239 | Inhalation |
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Poland |
|
| Chile |
|
| Title | Measurements |
|---|---|
|
| Gagging/regurgitation |
|
| Apnea |
|
| Pallor |
|
| OG003 | 150 mg/kg | 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) |
| OG004 | nCPAP Alone | nCPAP therapy alone nCPAP alone: nCPAP therapy |
|
|
| OG002 |
| 100 mg/kg |
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) |
| OG003 | 150 mg/kg | 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) |
| OG004 | nCPAP Alone | nCPAP therapy alone nCPAP alone: nCPAP therapy |
|
|
| OG003 | 150 mg/kg | 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) |
| OG004 | nCPAP Alone | nCPAP therapy alone nCPAP alone: nCPAP therapy |
|
|
| OG003 | 150 mg/kg | 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) |
| OG004 | nCPAP Alone | nCPAP therapy alone nCPAP alone: nCPAP therapy |
|
|
| OG003 | 150 mg/kg | 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) |
| OG004 | nCPAP Alone | nCPAP therapy alone nCPAP alone: nCPAP therapy |
|
|
| OG003 | 150 mg/kg | 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) |
| OG004 | nCPAP Alone | nCPAP therapy alone nCPAP alone: nCPAP therapy |
|
|
| OG003 | 150 mg/kg | 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) |
| OG004 | nCPAP Alone | nCPAP therapy alone nCPAP alone: nCPAP therapy |
|
|
| OG003 | 150 mg/kg | 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) |
| OG004 | nCPAP Alone | nCPAP therapy alone nCPAP alone: nCPAP therapy |
|
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