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Trial To Assess The Safety And Tolerability Of Lucinactant For Inhalation In Preterm Neonates 26 to 28 Weeks PMA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02528318
Recruitment Status : Terminated (Sponsor decision to terminate after 3 dosing groups)
First Posted : August 19, 2015
Results First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Windtree Therapeutics

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
Respiratory Distress Syndrome Combination Product: Lucinactant for inhalation Device: nCPAP alone 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.

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Study Type : Interventional  (Clinical Trial)
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 : August 2015
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : August 11, 2017


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 Name: AEROSURF®

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 Name: AEROSURF®

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 Name: AEROSURF®

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 Name: AEROSURF®

Active Comparator: nCPAP alone
nCPAP therapy alone
Device: nCPAP alone
nCPAP therapy
Other Name: nasal continuous positive airway pressure




Primary Outcome Measures :
  1. Number of Participants With Peri-Dosing Adverse Events - Initial Dose [ Time Frame: Randomization to 24 Hours Post Randomization ]
    Number of Participants with adverse events that were experienced during the initial study treatment

  2. Number of Participants With Air Leak [ Time Frame: 7 days ]
    Number of participants with air leak (includes pneumothorax, pulmonary interstitial emphysema (PIE), pneumomediastinum, pneumopericardium, subcutaneous emphysema)


Secondary Outcome Measures :
  1. Number of Participants With Worsening of Respiratory Status Criteria [ Time Frame: 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)

  2. Bronchopulmonary Dysplasia [ Time Frame: 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)

  3. Number of Participants With Nasal Continuous Positive Airway Pressure (nCPAP) Failure [ Time Frame: Randomization to 72 Hours Post Randomization ]
    Participants who required intubation for mechanical ventilation or surfactant administration were defined as having failed nCPAP

  4. Death [ Time Frame: Randomization to 36 weeks PMA ]
    Number of participants who died during the study

  5. FiO2 [ Time Frame: 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.

  6. Number of Participants With Complications of Prematurity [ Time Frame: Randomization to 36 weeks PMA ]
    Number of participants with pre-specified common complications of prematurity.


Other Outcome Measures:
  1. nCPAP Failure Without Treatment Interruptions [ Time Frame: Randomization to 72 Hours Post Randomization ]
    Number of subjects requiring mechanical ventilation or surfactant administration (nCPAP failure) but did not have a treatment interruption



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   26 Weeks to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed consent from a legally authorized representative.
  2. Gestational age 26 to 28 completed weeks post menstrual age (PMA).
  3. Successful implementation of controlled nCPAP within 90 minutes after birth.
  4. Spontaneous breathing.
  5. Chest radiograph consistent with RDS.
  6. 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:

  1. Heart rate that cannot be stabilized above 100 beats/minute within 5 minutes of birth.
  2. 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.
  3. A 5 minute Apgar score < 5.
  4. Major congenital malformation(s) and cranial/facial abnormalities that preclude nCPAP, diagnosed antenatally or immediately after birth.
  5. Other diseases or conditions potentially interfering with cardiopulmonary function (eg, hydrops fetalis or congenital infection such as TORCH).
  6. Known or suspected chromosomal abnormality or syndrome.
  7. Premature rupture of membranes (PROM) > 2 weeks.
  8. Evidence of hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis.
  9. Need for endotracheal intubation and mechanical ventilation.
  10. Has been administered: another investigational agent or investigational medical device, any other surfactant agent, steroid treatment after birth.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02528318


Locations
Show Show 20 study locations
Sponsors and Collaborators
Windtree Therapeutics
Investigators
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Study Director: Steve Simonson, MD Windtree Therapeutics
  Study Documents (Full-Text)

Documents provided by Windtree Therapeutics:
Statistical Analysis Plan  [PDF] May 13, 2015
Study Protocol  [PDF] September 2, 2015

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Responsible Party: Windtree Therapeutics
ClinicalTrials.gov Identifier: NCT02528318    
Other Study ID Numbers: 03-CL-1401
First Posted: August 19, 2015    Key Record Dates
Results First Posted: July 23, 2019
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases