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    Summary
    EudraCT Number:2021-003238-35
    Sponsor's Protocol Code Number:4_141221
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-22
    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 ConcernedNorway - NOMA
    A.2EudraCT number2021-003238-35
    A.3Full title of the trial
    Effects of supplemental oxygen on systemic and cerebral hemodynamics in experimental hypovolemia: A randomized, phase IV, crossover study to study the effect of supplemental oxygen vs. room air on cerebral and systemic hemodynamics in healthy volunteers > 18 years during experimental hypovolemia in the lower body negative pressure model of hypovolemia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of oxygen on the circulatory system and brain blood flow in experimental blood loss in helathy volunteers.
    A.3.2Name or abbreviated title of the trial where available
    Supplemental oxygen in hypovolemia
    A.4.1Sponsor's protocol code number4_141221
    A.5.4Other Identifiers
    Name:Regional Committees for Medical Research Ethics - Number:285164
    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 SponsorOslo University Hospital
    B.1.3.4CountryNorway
    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 supportOslo University Hospital
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportNorwegian Air Ambulance Foundation
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOslo University Hospital
    B.5.2Functional name of contact pointDepartment of Anesthesiology
    B.5.3 Address:
    B.5.3.1Street AddressKirkeveien 166
    B.5.3.2Town/ cityOslo
    B.5.3.3Post code0450
    B.5.3.4CountryNorway
    B.5.4Telephone number4722119690
    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 100 % medisinsk gass, komprimert
    D.2.1.1.2Name of the Marketing Authorisation holderLinde Gas, BOX 30193, 10425 Stockholm, Sweden
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 100 % medisinsk gass, komprimert
    D.3.4Pharmaceutical form Medicinal gas, compressed
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    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 Yes
    D.3.11.13.1Other medicinal product typeCompressed gas.
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboMedicinal gas, compressed
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypovolemia is the condition under investigation. Hypovolemia is induced by the "lower body negative pressure" (LBNP)-model.
    E.1.1.1Medical condition in easily understood language
    The study investigates the response to volume loss, e.g. bleeding, in a model where blood is displaced to the legs and lower abdomen.
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10049771
    E.1.2Term Shock haemorrhagic
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Supplemental oxygen is frequently administered in acutely and critically ill patients, specifically, it is often administered in trauma patients to avoid arterial hypoxemia and tissue hypoxia. There is also an increasing focus on potentially deleterious effects of hyperoxia. Further, the hemodynamic response to hyperoxia in hypovolemia is poorly understood.
    The present study aims to investigate the effects of supplemental oxygen on systemic and cerebral hemodynamics in simulated hypovolemia in healthy volunteers.
    E.2.2Secondary objectives of the trial
    The secondary objective is to determine the agreement between blood velocity in the medial cerebral and internal or common carotid arteries.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age > 18 years.
    - Age < 50 years.
    E.4Principal exclusion criteria
    1. Any medical condition limiting physical exertional capacity or requiring regular medication (allergy and contraceptives excepted).
    2. Pregnancy.
    3. Breastfeeding.
    4. History of syncope (syncope of presumed vasovagal nature with known precipitating factor excepted).
    5. Any known cardiac arrhythmia.
    Prior/Concomitant Therapy
    6. Any drug (contraceptives excepted) used on a regular basis for a chronic condition (allergy excepted).
    E.5 End points
    E.5.1Primary end point(s)
    Determine if there is an effect of supplemental oxygen on cardiac output during LBNP.

    Cardiac output will be measured continuously by volume-clamp method and suprasternal Doppler if needed (e.g. due to poor signal quality). The primary aim of the study is to test the difference of oxygen compared ro placebo. P-values <0.05 are considered statistically significant. Cardiac output will be entered as a continuous explanatory variable in a linear mixed effects regression model. Analyses will be performed by assigning variables (dummy coding) to each medication. Confidence intervals for the effect of each medication will be calculated using the glht-function of the “multcomp”-package in R with “single step” correction for multiple comparisons. No interim-analyses will be performed. Missing values will not be imputed, but are generally handled well in mixed effects regression models. The exact setup of the statistical model (e.g. random intercept vs. random slope, interaction effects, covariance structures etc.) will depend on details in the data. Analyses will be performed using the statistical software R (https://www.r-project.org/).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continuously during LBNP-exposure.
    E.5.2Secondary end point(s)
    • Effect of oxygen and LNBP on changes in middle cerebral artery blood flow velocity (MCAV).
    • Effect of oxygen and LNBP on changes in cardiac stroke volume.
    • Effect of oxygen and LNBP on changes time to decompensation.

    - Change in MCAV with increasing LBNP will be analyzed in a linear mixed effects model corresponding to cardiac output (see above).
    - Change in stroke volume with increasing LBNP will be analyzed in a linear mixed effects model corresponding to cardiac output (see above).
    - Time to hemodynamic decompensation will be compared between the three interventions in a mixed proportional hazards model (Cox regression).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Continuously during LBNP-exposure.
    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 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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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
    LVLS.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 15
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 Yes
    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 state15
    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)
    There will be no specific care after the subject has ended the participation in the trial.
    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 Decision2021-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-14
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