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    Summary
    EudraCT Number:2017-002022-20
    Sponsor's Protocol Code Number:NL61945.029.17
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-06-26
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-002022-20
    A.3Full title of the trial
    The effect of inspiratory oxygen fraction on the ratio of partial arterial oxygen pressure and inspiratory oxygen fraction (PaO2/FiO2 ratio) in mechanically ventilated patients with and without mild to moderate ARDS
    Het effect van de inspiratoire zuurstoffractie op de PaO2/FiO2 ratio in beademde patienten met en zonder milde tot matige ARDS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of the concentration of applied oxygen on the PaO2/FiO2 ratio as estimate for lung injury
    Het effect van de concentratie toegediende zuurstof op de PaO2/FiO2 ratio als maat voor longschade
    A.3.2Name or abbreviated title of the trial where available
    The effect of FiO2 on PaO2/FiO2 ratio
    Het effect van FiO2 op PaO2/FiO2 ratio
    A.4.1Sponsor's protocol code numberNL61945.029.17
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03156218
    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 SponsorVU University Medical Center
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportVU University Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU University Medical Center
    B.5.2Functional name of contact pointDepartment of Intensive Care
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31204443924
    B.5.6E-mailam.spoelstra@vumc.nl
    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 Yes
    D.2.1.1.1Trade name Conoxia
    D.2.1.1.2Name of the Marketing Authorisation holderLinde Health Care Benelux
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameConoxia
    D.3.4Pharmaceutical form Gas and solvent for dispersion for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXYGEN
    D.3.9.3Other descriptive nameConoxia
    D.3.9.4EV Substance CodeSUB14733MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number100
    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 No
    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
    We investigate the PaO2/FiO2 ratio in patients without and with mild to moderate ARDS
    We onderzoeken de PaO2/FiO2 ratio in patienten met en zonder mild tot matige ARDS
    E.1.1.1Medical condition in easily understood language
    We investigate the effect of inspired oxygen fraction on PaO2/FiO2 ratio as estimate of lung injury
    We onderzoeken het effect van de toegediende zuurstof fractie op PaO2/FiO2 ratio als maat voor longschade
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10003083
    E.1.2Term ARDS
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the effect of FiO2 on the PaO2/FiO2-ratio in mechanically ventilated patients post cardiac surgery without ARDS and with mild to moderate ARDS
    Het onderzoeken van het effect van FiO2 op de PaO2/FiO2-ratio in beademde patienten na cardiochirurgie zonder en met milde tot matige ARDS
    E.2.2Secondary objectives of the trial
    Shunt fraction, arteriovenous oxygen difference and alveolar – arterial oxygen difference
    Shunt fractie, arterioveneuze en alveolaire – arteriele zuurstofverschil
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All mechanically ventilated patients, admitted to the Intensive Care Unit of VU-Medical Center post cardiac surgery without ARDS and with mild to moderate ARDS will be screened for eligibility for this study. In order to be eligible to participate in this study, a subject must meet all of the following criteria:

    • Mechanically ventilated patients
    • Stable hemodynamics
    • Stable haemoglobin level
    • Stable body temperature
    • Stable level of sedation
    • Pulmonary-Artery and Artery catheter
    Alle beademde patienten, opgenomen op de Intensive Care van het VU Medisch centrum na cardiochirurgie zonder en met milde tot matige ARDS. Een patient moet aan de volgende criteria voldoen:

    • Beademde patienten
    • Stabiele hemodynamiek
    • Stabiele hemoglobine concentratie
    • Stabiele lichaams temperatuur
    • Stabiel sedatie niveau
    • Swan Ganz catheter en arterielijn
    E.4Principal exclusion criteria
    • Incomplete revascularization after CABG
    • Cardiac ischemia
    • Neurotrauma
    • Incomplete revascularizatie na CABG
    • Cardiale ischemie
    • Neurotrauma
    E.5 End points
    E.5.1Primary end point(s)
    The relationship between FiO2 and PaO2/FiO2-ratio
    De relatie tussen FiO2 en PaO2/FiO2-ratio
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 10 minutes after the start of the protocol
    Elke 10 minuten na de start van het protocol
    E.5.2Secondary end point(s)
    Shunt fraction, arteriovenous oxygen difference and alveolar – arterial oxygen difference
    Shunt fractie, arterioveneuze en alveolaire – arteriele zuurstof verschil
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 10 minutes after the start of the protocol
    Elke 10 minuten na de start van het protocol
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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
    De PaO2/FiO2 ratio van patienten zonderARDS wordt vergeleken met patienten met mild tot matige ARDS
    The PaO2/FiO2 ratio will be compared of patients without ARDS and mild to moderate ARDS
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    When the last patient has completed the protocol at the ICU.
    Als de laatste patient het protocol voltooid heeft op de Intensive Care.
    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 months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    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) Yes
    F.1.2.1Number of subjects for this age range: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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
    Geen
    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 Decision2017-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-27
    P. End of Trial
    P.End of Trial StatusOngoing
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