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    Summary
    EudraCT Number:2016-004551-67
    Sponsor's Protocol Code Number:SED001
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-06-12
    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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2016-004551-67
    A.3Full title of the trial
    A randomised, controlled, open-label study to confirm the efficacy and safety of sedation with isoflurane in invasively ventilated ICU patients using the AnaConDa administration system
    Randomizirana, nadzorovana, odprta študija za potrditev učinkovitosti in varnosti sedacije z izofluranom pri bolnikih med invazivnim nadzorovanim predihavanjem na oddelku za intenzivno zdravljenje z uporabo administracijskega sistema AnaConDa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised, controlled, open-label study to confirm the efficacy and safety of sedation with isoflurane in invasively ventilated ICU patients using the AnaConDa administration system
    Randomizirana, nadzorovana, odprta študija za potrditev učinkovitosti in varnosti sedacije z izofluranom pri bolnikih med invazivnim nadzorovanim predihavanjem na oddelku za intenzivno zdravljenje z uporabo administracijskega sistema AnaConDa.
    A.4.1Sponsor's protocol code numberSED001
    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 SponsorSedana Medical AB
    B.1.3.4CountrySweden
    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 supportSedana Medical AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinres Farmacija d. o .o.
    B.5.2Functional name of contact pointTjaša Rakovec
    B.5.3 Address:
    B.5.3.1Street AddressVilharjeva cesta 29
    B.5.3.2Town/ cityLjubljana
    B.5.3.3Post code1000
    B.5.3.4CountrySlovenia
    B.5.4Telephone number+38659074 004
    B.5.5Fax number+38659074 009
    B.5.6E-mailtjasa.rakovec@clinres.si
    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 Isofluran-Piramal
    D.2.1.1.2Name of the Marketing Authorisation holderPiramal Critical Care Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameIsofluran
    D.3.4Pharmaceutical form Inhalation vapour, liquid
    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 INNISOFLURANE
    D.3.9.1CAS number 26675-46-7
    D.3.9.4EV Substance CodeSUB08319MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Propofol HEXAL 20mg/ml Emulsion zur Injektion /Infusion, 50 ml Durchstechfl.
    D.2.1.1.2Name of the Marketing Authorisation holderHEXAL AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namePropofol
    D.3.4Pharmaceutical form Emulsion for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPROPOFOL
    D.3.9.1CAS number 2078-54-8
    D.3.9.3Other descriptive namePROPOFOL
    D.3.9.4EV Substance CodeSUB10116MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Adult subjects admitted to the ICU clinically indicated to require sedation with propofol and invasive ventilation
    E.1.1.1Medical condition in easily understood language
    ICU patient sedated and invasive ventilated
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that sedation with isoflurane is non-inferior to propofol in terms of maintaining adequate sedation without rescue sedation.
    E.2.2Secondary objectives of the trial
    Evaluate the safety profile of isoflurane compared to propofol in terms of experienced adverse events, biochemistry laboratory values, vital signs and organ function.
    Evaluate ability to breathe spontaneous and applied ventilator mode in subjects sedated with isoflurane compared to propofol.
    Efficacy objectives: Evaluate wake-up time during daily sedation stops in the ICU for subjects sedated with isoflurane compared to propofol.
    Evaluate use of analgesic agent and behavioural pain scale assessments (BPS) in subjects sedated with isoflurane compared to propofol.
    Evaluate time with invasive ventilation and days in ICU in the 30 days after end of study sedation for subjects sedated with isoflurane compared to propofol
    Evaluate the time to extubation for subjects sedated with isoflurane compared to propofol.







    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects, >= 18 years
    2. Continuous invasive ventilation and sedation <= 48 hours at start of study sedation
    3. Clinically likely to need invasive ventilation and sedation >= 24 hours at randomisation
    4. Ongoing sedation with propofol at time of randomisation
    5. Prescribed target sedation depth within the RASS range -1 to -4
    6. Signed informed consent or emergency situation inclusion criteria fulfilled and documented, according to procedure described in section 9.4
    E.4Principal exclusion criteria
    1. Has not reached prescribed target sedation depth any time within the last 8 hours at randomisation
    2. History of or genetic predisposal for malignant hyperthermia
    3. Uncompensated acute circulatory failure at time of randomisation (MAP < 55 mmHg despite iv fluids and vasopressors).
    4. Hepatic impairment of classification C according to the Child-Pugh score (Cholongitas et al., 2005).
    5. Any for the study relevant clinically significant abnormalities in clinical chemistry or haematology results at the time of screening , precluding study participation as judged by the investigator
    6. Acute neuropathology without ICP monitoring, including but not limited to stroke, neurosurgery and head trauma.
    7. Planned anaesthesia or surgery within 24 hours from randomisation
    8. Tidal volume < 350 ml
    9. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study
    10. Need for continuous muscle relaxation at the time of randomisation
    11. Positive pregnancy test in women
    12. History of allergy/hypersensitivity to isoflurane or propofol
    13. Known participation in any other clinical study that included drug treatment within three months of the first administration of investigational product
    14. Documented limitation of medical treatment.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of time when adequate sedation depth is maintained without rescue sedation with isoflurane compared to propofol as assessed according to RASS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 2 hrs from start of study medication is given until end of trial at max. 48hrs
    E.5.2Secondary end point(s)
    Safety endpoints
    Adverse events in terms of frequency and severity for subjects sedated with isoflurane compared to propofol.
    Changes in vital signs, clinical chemistry and haematology values over time for subjects sedated with isoflurane compared to propofol.
    Difference in ability to breathe spontaneously assessed as applied ventilator mode and spontaneous breathing trial (SBT) for subjects sedated with isoflurane compared to propofol.
    Changes in organ failure measured by Sequential Organ Failure Assessment (SOFA) from baseline and over time during the study, up to one week after end of study sedation for subjects sedated with isoflurane compared to propofol.
    Changes in organ functions seven and 30 days after end of study sedation for subjects sedated with isoflurane compared to propofol.
    Efficacy endpoints:
    Mean wake-up time for subjects sedated with isoflurane compared to propofol.
    Safety Endpoint:
    Dosing of opiates and BPS assessments in subjects sedated with isoflurane compared to propofol.
    Ventilator time and ventilator-free days in the 30 days after end of study sedation for subjects sedated with isoflurane compared to propofol.
    ICU length of stay and ICU-free days in the 30 days after end of study sedation for subjects sedated with isoflurane compared to propofol.
    Time to extubation of subjects being extubated during study for subjects sedated with isoflurane compared to propofol.





    E.5.2.1Timepoint(s) of evaluation of this end point
    From start of study sedation up to study end i.e. at the latest 48 hours. For adverse events it is up to after end of study sedation.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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) Yes
    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 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) Yes
    E.8.2.2Placebo No
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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 years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2019-06-12. Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Unconscious ICU patients cannot provide informed consent. For them the informed consent process will follow the instructions in the country-specific protocol




    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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 Decision2019-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-02-11
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