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The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age

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: NCT02636868
Recruitment Status : Completed
First Posted : December 22, 2015
Results First Posted : April 23, 2021
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
Windtree Therapeutics

Study Description
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Brief Summary:
The primary objective of this study is to evaluate the safety and efficacy of lucinactant for inhalation administered as an aerosolized dose in two doses to preterm neonates 26 - 32 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for Respiratory Distress Syndrome (RDS) compared to neonates receiving nCPAP alone.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Drug: Lucinactant delivered via investigational delivery device Drug: nCPAP Phase 2

Detailed Description:

The purpose of this study is to investigate the safety and efficacy of lucinactant for inhalation in preterm neonates 26 to 32 completed weeks post-menstrual age (PMA). Efficacy and safety are based on clinical evaluations. The endpoints specified are similar to those in Protocols 03-CL-1201 and 03-CL-1401 to allow for potential comparison and pooling of results.

The objective of this study is to evaluate the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, compared to nCPAP alone, in preterm neonates with RDS, as assessed by the time to and incidence of respiratory failure and/or death due to RDS over the first 72 hours of life, the incidence of bronchopulmonary dysplasia (BPD) at 36 weeks PMA, and change in physiologic parameters (FiO2 and PCO2) over the first 72 hours of life.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multinational, Multicenter, Masked, Randomized, Controlled Study to Assess The Safety and Efficacy of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age With Respiratory Distress Syndrome
Actual Study Start Date : December 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : August 6, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Aerosolized lucinactant (low dose)
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
 Drug: Lucinactant delivered via investigational delivery device
Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
Other Name: AEROSURF

Drug: nCPAP
Nasal CPAP
Experimental: Aerosolized lucinactant (high dose)
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
 Drug: Lucinactant delivered via investigational delivery device
Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
Other Name: AEROSURF

Drug: nCPAP
Nasal CPAP
Active Comparator: nasal CPAP
nCPAP alone
 Drug: nCPAP
Nasal CPAP


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Respiratory Failure or Death Due to Respiratory Distress Syndrome (RDS) [ Time Frame: 72 hours ]
    Number of participants who had respiratory failure due to RDS or death due to RDS; known as nasal continuous positive airway pressure (nCPAP) failure


Secondary Outcome Measures :
  1. Incidence of Respiratory Failure or Death Due to RDS [ Time Frame: 72 hours ]
    Incidence of Respiratory Failure or Death Due to RDS by Intubation or Failure Criteria

  2. Time to nCPAP Failure [ Time Frame: 72 hours ]
    Time from birth to nCPAP Failure

  3. Incidence of Respiratory Failure or Death Due to RDS With Poisson Distribution Modeling [ Time Frame: 72 hours ]
    The measure tests the differences between treatments on respiratory failure or death due to RDS using Poisson distribution modeling, which accounts for the time over which the event could have occurred.

  4. Incidence of Respiratory Failure or Death Due to RDS [ Time Frame: 28 days ]
    Incidence of Respiratory Failure or Death due to RDS by Intubation or Failure Criteria

  5. Number of Participants With Bronchopulmonary Dysplasia (BPD) [ Time Frame: 36 weeks post-menstrual age (PMA) ]
    Summarizes the number of participants with BPD or alive without BPD


Eligibility Criteria
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Ages Eligible for Study:   26 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent form (ICF) from legally authorized representative
  2. 26 0/7 to 32 6/7 completed weeks gestation PMA
  3. Successful implementation of non-invasive support or ventilation within 90 minutes after birth
  4. Spontaneous breathing
  5. Chest radiograph consistent with RDS
  6. Within the first 20 hours after birth requires an nCPAP of 5 to 7 centimeters water (cmH2O) with a fraction of inspired oxygen (FiO2) of ≥ 0.25 (>0.21 for neonates 26-28 weeks PMA) to 0.40 that is clinically indicated for at least 30 minutes to maintain oxygen by pulse oximetry (SpO2) of 90% to 95%. Transient (<10 minutes) FiO2 excursions outside this range do not reset the 30-minute requirement.

Exclusion Criteria:

  1. A heart rate that cannot be stabilized above 100 beats per minute (bpm) within 5 minutes of birth
  2. Recurrent episodes of apnea requiring positive pressure ventilation (PPV) administered manually or mechanically through any patient interface
  3. A 5 minute Apgar score < 5
  4. Major congenital malformation(s) or craniofacial abnormalities that preclude the use of nCPAP, diagnosed antenatally or immediately after birth
  5. Clinically significant diseases or conditions other than RDS which could potentially interfere with cardiopulmonary function (e.g. congenital heart disease, hydrops fetalis or congenital infection)
  6. A known or suspected chromosomal abnormality or syndrome
  7. Premature rupture of membranes (PROM) > 3 weeks
  8. Hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis
  9. A need for intubation and/or mechanical ventilation at any time before enrollment into the study

  10. The administration (or plan for administration) of any the following:

    • Another investigational agent or investigational medical device
    • Any other surfactant agent
    • Systemic corticosteroids (other than antenatal steroids already received)
  11. Presence of air leak (pneumothorax, pneumomediastinum, pneumopericardium, subcutaneous emphysema, or definite evidence of pulmonary interstitial emphysema (PIE)) on the baseline chest radiograph
Contacts and Locations
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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): NCT02636868


Locations
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Sponsors and Collaborators
Windtree Therapeutics
Investigators
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Study Director: Steven Simonson, MD Windtree Therapeutics
  Study Documents (Full-Text)

Documents provided by Windtree Therapeutics:
Study Protocol  [PDF] April 19, 2017
Statistical Analysis Plan  [PDF] April 27, 2017
Informed Consent Form  [PDF] February 25, 2016

More Information
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Responsible Party: Windtree Therapeutics
ClinicalTrials.gov Identifier: NCT02636868    
Other Study ID Numbers: 03-CL-1202
First Posted: December 22, 2015    Key Record Dates
Results First Posted: April 23, 2021
Last Update Posted: April 23, 2021
Last Verified: March 2021
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Syndrome
Disease
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases