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    Summary
    EudraCT Number:2015-005624-26
    Sponsor's Protocol Code Number:03-CL-1401
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-02-25
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2015-005624-26
    A.3Full title of the trial
    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.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An international study at different study sites testing the safety and tolerability of a drug, lucinactant, which is to be inhaled as a means to treat breathing problems in babies born prematurely in the 26 to 28 weeks.
    A.4.1Sponsor's protocol code number03-CL-1401
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02528318
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorWindtree Therapeutics, Inc. (formerly Discovery Laboratories, Inc.)
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportWindtree Therapeutics, Inc. (formerly Discovery Laboratories, Inc.)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Consulting Sp. z o.o.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressDzwonkowa 104
    B.5.3.2Town/ cityTychy
    B.5.3.3Post code43-100
    B.5.3.4CountryPoland
    B.5.4Telephone number+48322272005
    B.5.5Fax number+48323298426
    B.5.6E-mailoffice@clinicalconsulting.pl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/04/216; EU/3/04/217
    D.3 Description of the IMP
    D.3.1Product nameLyophilized lucinactant
    D.3.4Pharmaceutical form Nebuliser solution
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPRespiratory use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSINAPULTIDE
    D.3.9.1CAS number 138531-07-4
    D.3.9.4EV Substance CodeSUB10530MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,862
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdipalmitoylphosphatidylcholine
    D.3.9.1CAS number 63-89-8
    D.3.9.3Other descriptive name1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHATIDYLCHOLINE (DPPC)
    D.3.9.4EV Substance CodeSUB22681
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number22,5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPalmitic acid
    D.3.9.1CAS number 57-10-3
    D.3.9.3Other descriptive namePALMITIC ACID
    D.3.9.4EV Substance CodeSUB14744MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4,05
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpalmitoyloleoyl-phosphatidylglycerol
    D.3.9.1CAS number 268550-95-4
    D.3.9.3Other descriptive namePALMITOYL-OLEOYL PHOSPHATIDYLGLYCEROL
    D.3.9.4EV Substance CodeSUB126307
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7,5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Respiratory Distress Syndrome (RDS)
    E.1.1.1Medical condition in easily understood language
    Breathing difficulty in babies born prematurely
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10021735
    E.1.2Term Infant respiratory distress syndrome
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10038690
    E.1.2Term Respiratory distress syndrome (neonatal)
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10028974
    E.1.2Term Neonatal respiratory distress syndrome
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the safety and tolerability of lucinactant for inhalation, administered as an aerosolized dose in 4 escalating doses to a preterm, neonatal population 26 to 28 completed weeks PMA receiving nCPAP for RDS compared with neonates receiving nCPAP alone.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to determine the maximum tolerated dose of lucinactant as determined by the safety evaluations obtained within each dosing group, and to assess the feasibility of evaluating physiological pulmonary function parameters as a measure of improvement in clinical status in preterm neonates 26 to 28 completed weeks PMA who are receiving nCPAP for RDS, compared with neonates receiving nCPAP alone.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Signed ICF from legally authorized representative;
    2.Gestational age 26 to 28 completed weeks 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, requires an nCPAP of 5 to 6 cm H2O to maintain SpO2 of 88% to 95% with an 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 do not reset the 30 minute requirement.
    E.4Principal exclusion criteria
    1.Heart rate that cannot be stabilized above 100 beats per minutes 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/or mechanical ventilation;
    10.Has been administered any the following:
    a)Another investigational agent or investigational medical device,
    b)Administration of any other surfactant agent,
    c)Steroid treatment (exposure before birth is acceptable).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints of this study will be derived from the safety evaluations, including adverse device effects (ADEs) reported from the time of randomization until 36 weeks PMA of upon discharge .
    E.5.1.1Timepoint(s) of evaluation of this end point
    the first 72 hours of life
    E.5.2Secondary end point(s)
    Primary and Secondary Safety and Tolerability Measures:
    •Primary Observation Period (Day 1 and 2):
    1.Survival
    2.Use of respiratory support and supplemental oxygen
    3.Incidences leading to early discontinuation of aerosolized lucinactant administration
    4.Incidence of worsening respiratory status
    5.Incidence of air leak
    6.AEs, including ADEs (specifically including peri-dosing events and nasal excoriations)
    7.Complications of prematurity
    8.Concomitant medication
    9.Physical exam findings
    10.Tolerability of lucinactant for inhalation
    11.Assessments of the following:
    a)Vital signs
    b)Oxygen saturations (SpO2)
    c)Partial pressure of carbon dioxide (PCO2) values
    d)FiO2 values
    e)Serum electrolyte measurements
    f)Body weight
    g)Gastric liquid volume
    h)Defecation
    12.Chest radiography prior to non-emergent intubation, or in cases of worsening respiratory status, if such a procedure does not delay or compromise the emergent care of the subject

    •Extended Observation Period (Day 3 until Day 7):
    1.Survival
    2.Incidences leading to withdrawal from study
    3.Incidence of worsening respiratory status
    4.AEs, including ADEs
    5.Complications of prematurity
    6.Concomitant medication
    7.Assessment of the following:
    •Vital signs
    •O2 saturation values
    •FiO2 values through 72 hours
    •PCO2 values through 72 hours
    8.Chest radiography prior to non-emergent intubation, or in cases of worsening respiratory status, if such a procedure does not delay or compromise the emergent care of the subject.
    9.Use of respiratory support and supplemental oxygen

    •Final Observation Period (Day 8 to 36 Weeks PMA or discharge):
    1.Survival
    2.Incidences leading to withdrawal from study
    3.Incidence of worsening respiratory distress
    4.AEs, including ADEs
    5.Physical exam findings
    6.Concomitant medications
    7.Use of respiratory support and supplemental oxygen
    8.Complications of prematurity
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 36 weeks PMA
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    nCPAP - Continuous positive airway pressure/nasal
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Chile
    Poland
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 64
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 64
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pedriatric patients.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 64
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-07-07
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