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CompletedNCT02074059Updated Apr 21, 2017Results posted

Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates

A Phase 2 interventional study of Lucinactant for Inhalation and nCPAP alone in Respiratory Distress Syndrome, sponsored by Windtree Therapeutics. Completed at 11 sites in United States. Open to participants aged 29 Weeks to 34 Weeks. Per ClinicalTrials.gov, last updated 2017-04-21.

Sponsored by Windtree Therapeutics · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
29 Weeks to 34 Weeks
Sex
All
01

Study summary

The primary objective of this study is to evaluate the safety and tolerability of aerosolized surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses to preterm neonates 29 to 34 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS), compared to neonates receiving nCPAP alone.

02

Conditions studied

  • Respiratory Distress Syndrome
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 80 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Windtree Therapeutics is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
29 Weeks to 34 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Informed consent from a legally authorized representative
  • Gestational age 29 to 34 completed weeks (34 weeks 6 days) post menstrual age (PMA)
  • Successful implementation of controlled nCPAP within 90 minutes after birth
  • Spontaneous breathing
  • Chest radiograph consistent with RDS
  • Need for moderate levels of supplemental oxygen and nCPAP to maintain oxygen saturation of 88% to 95% for at least 30 minutes within the first 21 hours after birth

Exclusion criteria

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
  • Prolong 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 exposure to an investigational medical device, any other surfactant agent, steroid treatment after birth
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Aerosolized lucinactant (25 mg/kg)

    25 mg total phospholipids (TPL)/kg: Lucinactant for inhalation with nCPAP

    Drug: Lucinactant for Inhalation

  • Experimental
    Aerosolized lucinactant (50 mg/kg)

    50 mg TPL/kg: Lucinactant for inhalation with nCPAP

    Drug: Lucinactant for Inhalation

  • Experimental
    Aerosolized lucinactant (75 mg/kg)

    75 mg TPL/kg: Lucinactant for inhalation with nCPAP

    Drug: Lucinactant for Inhalation

  • Experimental
    Aerosolized lucinactant (100 mg/kg)

    100 mg TPL/kg: Lucinactant for inhalation with nCPAP; repeat dosing possible if criteria met.

    Drug: Lucinactant for Inhalation

  • Experimental
    Aerosolized lucinactant (150 mg/kg)

    150 mg TPL/kg: Lucinactant for inhalation with nCPAP; repeat dosing possible if criteria met.

    Drug: Lucinactant for Inhalation

  • Active comparator
    nCPAP alone

    nCPAP therapy alone

    Device: nCPAP alone

Interventions

  • DrugLucinactant for Inhalation

    Lucinactant for Inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)

    Also known as: Aerosurf

  • DevicenCPAP alone

    nCPAP therapy

    Also known as: nasal continuous positive airway pressure

06

What researchers measure

Primary outcomes

  1. Peri-Dosing Events

    Pre-specified adverse events that occured during treatment administration; does not include nCPAP alone

    Time frame: Within 48 Hours after Initiation of Study Treatment

  2. All Cause Mortality

    Time frame: Within 36 Weeks PMA

  3. Oxygen Saturation Levels

    Oxygen saturation as determined by pulse oximetry

    Time frame: Within 3 Hours of Randomization

  4. Serum Electrolytes

    Time frame: 24 Hours Post Randomization

Secondary outcomes

  1. PCO2

    Arterial carbon dioxide

    Time frame: Within 3 Hours of Randomization

07

Results

Posted Apr 21, 2017

Participant flow

Participant flow — Overall Study
MilestoneAerolized Lucinactant (25 mg/kg)Aerosolized Lucinactant (50 mg/kg)Aerosolized Lucinactant (75 mg/kg)Aerosolized Lucinactant (100 mg/kg)Aerosolized Lucinactant (150 mg/kg)nCPAP Alone
Started8888840
Completed8888739
Not completed000011
Withdrew: Death000011

Outcome measures

PrimaryPeri-Dosing Events

Pre-specified adverse events that occured during treatment administration; does not include nCPAP alone

Time frame:
Within 48 Hours after Initiation of Study Treatment
Reported as:
Number · participants
Peri-Dosing Events
participantsAerolized Lucinactant (25 mg/kg)Aerosolized Lucinactant (50 mg/kg)Aerosolized Lucinactant (75 mg/kg)Aerosolized Lucinactant (100 mg/kg)Aerosolized Lucinactant (150 mg/kg)nCPAP Alone
Bradycardia00010—
Desaturation20120—
Vomiting00110—
PrimaryAll Cause Mortality
Time frame:
Within 36 Weeks PMA
Reported as:
Number · participants
All Cause Mortality
participantsAerolized Lucinactant (25 mg/kg)Aerosolized Lucinactant (50 mg/kg)Aerosolized Lucinactant (75 mg/kg)Aerosolized Lucinactant (100 mg/kg)Aerosolized Lucinactant (150 mg/kg)nCPAP Alone
All Cause Mortality000011
PrimaryOxygen Saturation Levels

Oxygen saturation as determined by pulse oximetry

Time frame:
Within 3 Hours of Randomization
Reported as:
Mean · percentage of oxygen saturation
Oxygen Saturation Levels
percentage of oxygen saturationAerolized Lucinactant (25 mg/kg)Aerosolized Lucinactant (50 mg/kg)Aerosolized Lucinactant (75 mg/kg)Aerosolized Lucinactant (100 mg/kg)Aerosolized Lucinactant (150 mg/kg)nCPAP Alone
At Randomization94.0 ± 091.3 ± 2.7396.4 ± 2.2093.9 ± 3.8792.5 ± 3.8593.3 ± 2.66
At Initiation of Treatment93.0 ± 4.0093.3 ± 1.3793.4 ± 4.2494.0 ± 3.8293.1 ± 1.25—
15 Minutes Post Radomization/Treatment94.0 ± 092.7 ± 4.6894.8 ± 5.1594.8 ± 3.6292.0 ± 4.6693.3 ± 3.39
30 Minutes Post Randomization/Treatment93.5 ± 2.1292.3 ± 2.2592.5 ± 5.9593.3 ± 4.8391.4 ± 3.8993.6 ± 3.33
45 Minutes Post Randomization/Treatment94.5 ± 0.7191.3 ± 3.8894.0 ± 4.7293.8 ± 3.1193.0 ± 2.2793.7 ± 3.04
60 Minutes Post Randomization/Treatment92.0 ± 093.7 ± 2.0796.1 ± 2.4793.9 ± 3.7291.9 ± 3.0093.5 ± 3.68
1.25 Hours Post Randomization/Treatment94.0 ± 093.2 ± 4.7195.6 ± 2.3394.0 ± 3.3292.0 ± 5.2693.9 ± 3.05
1.5 Hours Post Randomization/Treatment95.0 ± 4.2493.7 ± 3.2794.9 ± 3.5293.1 ± 6.3488.1 ± 16.9893.4 ± 2.83
1.75 Hours Post Randomization/Treatment92.3 ± 8.3393.3 ± 4.1395.4 ± 2.4594.6 ± 4.7293.4 ± 5.4293.9 ± 2.61
2.00 Hours Post Radomization/Treatment97.0 ± 090.2 ± 6.2495.0 ± 2.7893.9 ± 3.8793.4 ± 3.5893.5 ± 2.33
2.25 Hours Post Randomization/Treatment90.5 ± 2.1292.3 ± 2.4294.5 ± 3.3894.9 ± 3.1892.8 ± 4.4693.4 ± 2.63
2.50 Hours Post Randomization91.0 ± 093.3 ± 1.3795.0 ± 2.6294.0 ± 3.6193.6 ± 4.3193.4 ± 3.19
2.75 Hours Post Randomization/Treatment98.0 ± 094.5 ± 1.2994.1 ± 3.6494.7 ± 2.6392.8 ± 4.1393.5 ± 2.99
3.00 Hours Post Randomization—93.5 ± 5.4595.0 ± 2.4595.4 ± 3.4694.9 ± 3.3693.9 ± 2.52
PrimarySerum Electrolytes
Time frame:
24 Hours Post Randomization
Reported as:
Mean · mEq/L
Serum Electrolytes
mEq/LAerolized Lucinactant (25 mg/kg)Aerosolized Lucinactant (50 mg/kg)Aerosolized Lucinactant (High Dose)Aerosolized Lucinactant (100 mg/kg)Aerosolized Lucinactant (150 mg/kg)nCPAP Alone
Sodium140 ± 3.7137 ± 4.0139 ± 4.2140 ± 4.9137 ± 4.3139 ± 3.3
Chloride108 ± 3.0107 ± 4.2107 ± 6.6107 ± 6.3105 ± 4.5108 ± 3.5
Potassium3.86 ± 0.2624.66 ± 1.2353.86 ± 0.4534.46 ± 1.0294.09 ± 0.9934.47 ± 1.082
Total Carbon Dioxide20.8 ± 1.8321.3 ± 2.1222.0 ± 1.6024.5 ± 7.5021.9 ± 1.8921.7 ± 3.12
SecondaryPCO2

Arterial carbon dioxide

Time frame:
Within 3 Hours of Randomization
Reported as:
Mean · percentage of arterial carbon dioxide
PCO2
percentage of arterial carbon dioxideAerolized Lucinactant (25 mg/kg)Aerosolized Lucinactant (50 mg/kg)Aerosolized Lucinactant (75 mg/kg)Aerosolized Lucinactant (100 mg/kg)Aerosolized Lucinactant (150 mg/kg)nCPAP Alone
At Randomization58.0 ± 0.0054.3 ± 8.9647.1 ± 8.3249.6 ± 10.7357.4 ± 10.2849.2 ± 12.10
At Initiation of Treatment29.0 ± 1.7353.0 ± 9.3452.3 ± 11.3446.6 ± 11.3557.5 ± 6.79—
15 Minutes Post Randomization/Treatment—50.1 ± 10.4253.1 ± 16.0345.6 ± 9.8153.0 ± 8.3549.5 ± 10.82
30 Minutes Post Randomization/Treatment38.0 ± 12.7353.1 ± 8.3748.4 ± 12.1344.7 ± 9.6255.0 ± 4.2048.1 ± 9.84
45 Minutes Post Randomization/Treatment32.0 ± 0.0050.3 ± 7.9446.2 ± 9.4145.1 ± 10.2752.6 ± 6.6847.1 ± 9.67
60 Minutes Post Randomization/Treatment39.0 ± 0.0049.7 ± 9.6247.3 ± 11.5346.2 ± 10.0251.6 ± 7.6247.8 ± 7.85
1.25 Hours Post Randomization/Treatment—50.5 ± 9.7246.8 ± 10.5544.3 ± 10.7452.7 ± 8.7047.5 ± 8.65
1.50 Hours Post Randomization/Treatment—47.5 ± 9.6246.0 ± 11.3245.6 ± 10.4052.3 ± 10.6447.9 ± 7.12
1.75 Hours Post Randomization/Treatment48.0 ± 0.0045.7 ± 8.4444.6 ± 9.1046.7 ± 8.7351.8 ± 7.8048.1 ± 6.46
2.00 Hours Post Randomization/Treatment30.0 ± 0.0046.6 ± 7.7245.3 ± 8.8946.9 ± 9.2451.0 ± 8.7348.8 ± 5.90
2.25 Hours Post Randomization/Treatment33.5 ± 10.6145.4 ± 8.4947.3 ± 5.9445.6 ± 8.0052.9 ± 8.5248.2 ± 8.56
2.50 Hours Post Randomization/Treatment36.0 ± 0.0045.6 ± 7.2042.4 ± 10.9546.3 ± 10.0052.0 ± 8.0948.2 ± 7.64
2.75 Hours Post Randomization/Treatment37.0 ± 0.0044.2 ± 5.0246.0 ± 4.7346.8 ± 8.2949.9 ± 7.8347.3 ± 6.94
3.00 Hours Post Randomization/Treatment—45.6 ± 6.5445.2 ± 5.1945.9 ± 8.0651.6 ± 7.0946.3 ± 7.01

Adverse events

Collected over From enrollment to 36 weeks post-menstrual age (PMA). As infants are enrolled at a gestational age of 29 to 34 weeks PMA, this represents a period of 2 to 7 weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Aerolized Lucinactant (25 mg/kg)—2/8 (25%)8/8 (100%)
Aerosolized Lucinactant (50 mg/kg)—3/8 (37.5%)8/8 (100%)
Aerosolized Lucinactant (75 mg/kg)—2/8 (25%)8/8 (100%)
Aerosolized Lucinactant (100 mg/kg)—3/8 (37.5%)7/8 (87.5%)
Aerosolized Lucinactant (150 mg/kg)—3/8 (37.5%)8/8 (100%)
nCPAP Alone—7/40 (17.5%)37/40 (92.5%)
Most frequent serious events
Most frequent serious events
EventAerolized Lucinactant (25 mg/kg)Aerosolized Lucinactant (50 mg/kg)Aerosolized Lucinactant (75 mg/kg)Aerosolized Lucinactant (100 mg/kg)Aerosolized Lucinactant (150 mg/kg)nCPAP Alone
PneumothoraxRespiratory, thoracic and mediastinal disorders2/82/81/82/82/84/40
Necrotising Enterocolitis NeonatalGastrointestinal disorders0/81/80/81/80/81/40
Cadio-respiratory ArrestRespiratory, thoracic and mediastinal disorders0/80/80/80/81/80/40
Apnoea NeonatalRespiratory, thoracic and mediastinal disorders0/80/81/80/80/80/40
PneumomediastinumRespiratory, thoracic and mediastinal disorders0/81/80/80/80/80/40
HydrocephalusNervous system disorders0/80/80/80/80/81/40
Pulmonary HaemorrhageRespiratory, thoracic and mediastinal disorders0/80/80/80/80/81/40
Cardio-respiratory ArrestCardiac disorders0/80/80/80/80/81/40
Most frequent other events
Showing 10 of 111
Most frequent other events
EventAerolized Lucinactant (25 mg/kg)Aerosolized Lucinactant (50 mg/kg)Aerosolized Lucinactant (75 mg/kg)Aerosolized Lucinactant (100 mg/kg)Aerosolized Lucinactant (150 mg/kg)nCPAP Alone
Jaundice NeonatalPregnancy, puerperium and perinatal conditions8/88/87/85/87/830/40
Apnoea NeonatalRespiratory, thoracic and mediastinal disorders6/83/84/82/84/823/40
ConstipationGastrointestinal disorders5/86/82/82/85/814/40
Anaemia NeonatalBlood and lymphatic system disorders5/83/81/81/81/815/40
Neonatal Respiratory Distress SyndromePregnancy, puerperium and perinatal conditions5/82/81/80/80/86/40
Dermatitis DiaperSkin and subcutaneous tissue disorders4/83/81/83/82/816/40
Metabolic AcidosisMetabolism and nutrition disorders4/82/80/81/81/811/40
Oxygen Saturation DecreasedInvestigations3/80/80/81/80/85/40
Sepsis NeonatalInfections and infestations3/81/80/81/82/83/40
BradycardiaCardiac disorders1/81/81/82/80/86/40

Baseline characteristics

All randomized subjects

Age, Categorical
Age, Categorical(Participants)Aerolized Lucinactant (25 mg/kg)Aerosolized Lucinactant (50 mg/kg)Aerosolized Lucinactant (75 mg/kg)Aerosolized Lucinactant (100 mg/kg)Aerosolized Lucinactant (150 mg/kg)nCPAP AloneTotal
<=18 years888884080
Between 18 and 65 years0000000
>=65 years0000000
Sex: Female, Male
Sex: Female, Male(Participants)Aerolized Lucinactant (25 mg/kg)Aerosolized Lucinactant (50 mg/kg)Aerosolized Lucinactant (75 mg/kg)Aerosolized Lucinactant (100 mg/kg)Aerosolized Lucinactant (150 mg/kg)nCPAP AloneTotal
Female354362142
Male534521938
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Aerolized Lucinactant (25 mg/kg)Aerosolized Lucinactant (50 mg/kg)Aerosolized Lucinactant (75 mg/kg)Aerosolized Lucinactant (100 mg/kg)Aerosolized Lucinactant (150 mg/kg)nCPAP AloneTotal
Hispanic or Latino142221122
Not Hispanic or Latino746662958
Unknown or Not Reported0000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Aerolized Lucinactant (25 mg/kg)Aerosolized Lucinactant (50 mg/kg)Aerosolized Lucinactant (75 mg/kg)Aerosolized Lucinactant (100 mg/kg)Aerosolized Lucinactant (150 mg/kg)nCPAP AloneTotal
American Indian or Alaska Native0000000
Asian0030025
Native Hawaiian or Other Pacific Islander0000000
Black or African American2001047
White454563054
More than one race1000001
Unknown or Not Reported13122413
Region of Enrollment
Region of Enrollment(participants)Aerolized Lucinactant (25 mg/kg)Aerosolized Lucinactant (50 mg/kg)Aerosolized Lucinactant (75 mg/kg)Aerosolized Lucinactant (100 mg/kg)Aerosolized Lucinactant (150 mg/kg)nCPAP AloneTotal
United States888884080
Gestational Age
Gestational Age(weeks)Aerolized Lucinactant (25 mg/kg)Aerosolized Lucinactant (50 mg/kg)Aerosolized Lucinactant (75 mg/kg)Aerosolized Lucinactant (100 mg/kg)Aerosolized Lucinactant (150 mg/kg)nCPAP AloneTotal
Mean30.5 ± 0.8131.8 ± 1.5033.3 ± 2.1131.7 ± 2.1032.3 ± 1.9531.5 ± 1.5631.7 ± 1.74
08

Study locations

11 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35249, United States
  • Arkansas Children's Hospital
    Little Rock, Arkansas 72202, United States
  • Loma Linda University Medical Center
    Loma Linda, California 92354, United States
  • Sharp Mary Birch Hospital for Women and Newborns
    San Diego, California 92123, United States
  • Christiana Care Health System
    Newark, Delaware 19713, United States
  • University of Miami
    Miami, Florida 33136, United States
  • Riley Hospital for Children at IU Health
    Indianapolis, Indiana 46202, United States
  • University of Louisville
    Louisville, Kentucky 40202, United States
  • Mid Atlantic Neonatology Associates
    Morristown, New Jersey 07960, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • Providence St. Vincent Medical Center
    Portland, Oregon 97225, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02074059
Lead sponsor
Windtree Therapeutics
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Feb 28, 2014
Start date
Feb 2014
Primary completion
Oct 2015
Completion
Nov 2015
Results posted
Apr 21, 2017
Last update
Apr 21, 2017

Study contacts

Robert Segal, MD, FACP
principal investigator · Windtree Therapeutics, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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