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    Summary
    EudraCT Number:2016-000160-42
    Sponsor's Protocol Code Number:M2016
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-03-22
    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 ConcernedAustria - BASG
    A.2EudraCT number2016-000160-42
    A.3Full title of the trial
    Effect of inhaled budenoside on the incidence and severity of Acute Mountain Sickness at 4559 m
    Effekt von inhalativem Budesonid auf die Inzidenz und den Schweregrad der Akuten Bergkrankheit in 4559 m.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of a inhaled corticoid on the Acute Mountain Sickness at 4559m
    Effekt von inhalativem Kortison auf die Akute Bergkrankheit in 4559m.
    A.3.2Name or abbreviated title of the trial where available
    Inhaled budenoside and AMS
    A.4.1Sponsor's protocol code numberM2016
    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 SponsorUK für Anästhesiologie und allgemeine Intensivmedizin
    B.1.3.4CountryAustria
    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 supportUK für Anästhesiologie und allgemeine Intensivmedizin
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUK für Anästhesiologie und allgemeine Intensivmedizin
    B.5.2Functional name of contact pointSekretariat
    B.5.3 Address:
    B.5.3.1Street AddressMüllner Hauptstraße 48
    B.5.3.2Town/ citySalzburg
    B.5.3.3Post code5020
    B.5.3.4CountryAustria
    B.5.4Telephone number00435725524001
    B.5.5Fax number00435725524199
    B.5.6E-mailma.berger@salk.at
    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 Budenoside 0,1
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameBudesonid 0,1mg
    D.3.4Pharmaceutical form Inhalation powder
    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 INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.9.4EV Substance CodeSUB05955MIG
    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 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 Budenoside 0,4mg
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameBudesonid 0,4mg
    D.3.4Pharmaceutical form Inhalation powder
    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 INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.9.4EV Substance CodeSUB05955MIG
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation powder, hard capsule
    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
    Healthy volunteer trial at 4459m to investigate the effect of inhaled budenoside on the incidence and severity of Acute Mountain Sickness.
    Studie an gesunden Freiwilligen auf 4559m um Effekte von inhalativem Budesonid auf die Inzidenz und den Schweregrad der Akuten Bergkrankheit zu untersuchen.
    E.1.1.1Medical condition in easily understood language
    Acute mountain sickness (AMS) is a constellation of symptoms (headache, nausea, lightheadedness, fatigue, and poor sleep) occurring in unacclimatized mountaineers ascending too fast, too high
    Die Akute Bergkrankheit besteht aus Kopfschmerz, Übelkeit, Verwirrtheit, Müdigkeit und Schlaflosigkeit und tritt bei nicht-akklimatisierten Bergsteigern auf, die zu schnell in zu große Höhe aufsteigen
    E.1.1.2Therapeutic area Body processes [G] - Physical Phenomena [G01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10020045
    E.1.2Term High altitude illness
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Does inhaled budenoside reduce the incidence of AMS after rapid and active ascent to 4559 m?
    Reduziert inhalatives Budesonid die Inzidenz der Akuten Bergkrankheit nach schnellem und aktivem Aufstieg auf 4559m?
    E.2.2Secondary objectives of the trial
    1.Does inhaled budenoside reduce the severity of AMS after rapid and active ascent to 4559 m?
    2.Are the effects of inhaled budenoside on AMS incidence and severity related to its plasma concentration?
    1. Reduziert inhalatives Budesonid den Schweregrad der Akuten Bergkrankheit nach schnellem und aktivem Aufstieg auf 4559m?
    2. Sind die Effekte von inhalativem Budesonid auf Inzidenz und Schweregrad der Akuten Bergkrankheit abhängig von der Plasmakonzentration von Budenosid?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age 18-60 years
    -Good physical condition
    -No relevant pathologies upon the pre-examination prior to the study
    -Written informed consent to participate in the study
    -Males and females are included without prioritization
    -Permanent residency below 1000 m
    -Alter: 18-60 Jahre
    -Guter Gesundheitszustand (geistig/körperlich)
    -Keine klinisch relevanten pathologischen Befunde bei der Voruntersuchung
    -Freiwillig unterzeichnete Einverständniserklärung nach vollständiger Information bezüglich der Studie
    -Bezüglich der Geschlechterverteilung gibt es keine Vorgaben und werden Männer und Frauen gleichermaßen berücksichtigt
    - Wohnhaft unter 1000m
    E.4Principal exclusion criteria
    -Acute and chronic lung diseases
    -Conventional systolic blood pressure (average of two measurements) ≥150 mmHg and conventional diastolic blood pressure ≥95 mmHg in untreated or treated subjects Cardiovascular diseases other than hypertension (coronary heart disease, heart failure, atrial fibrillation, peripheral artery disease)
    -Chronic headache / migraine
    -Diabetes mellitus
    -Smoking (>6 cigarettes/day) or equivalent nicotine substitutes
    -Alcohol (>30 g/d) or drug abuse
    -Obesity (Body Mass Index >30)
    -Other conditions deemed relevant by the investigator (including liver disease, renal disease, thyroid disorders)
    -Sojourn >2000 m within the last 4 weeks before the 1st study day
    -Drug intake within the last 2 moth before the 1st study day if the drug intake could affect the data quality (eg. corticosteroids) or the safety of the participants (eg. anti- coagulants)
    -Blood donation within the last 2 month before the 1st study day
    -Akute und chronische Lungenerkrankungen
    -Koronare Herzerkrankung
    -Systolischer Blutdruck (Durchschnitt von 2 Messungen)≥150 mmHg und diastolischer Blutdruck ≥ 95mmHg bei behandelten und unbehandelten Probanden.
    - pAVK und Gefäßanomalien
    - Chronischer Kopfschmerz / Migräne
    - Diabetes mellitus
    - Leber- und Nierenfunktionsstörungen
    - Nikotinkonsum (>6 Zigaretten/Tag), Nicorette
    - Alkoholabusus (>30 g/Tag), Drogenabusus
    - Adipositas (Body Mass Index >30)
    - Aufenthalt über 2000 m innerhalb der letzten 4 Wochen vor dem Untersuchungsbeginn
    - Medikamenteneinnahme innerhalb der letzten 2 Monate, wenn sie die Probanden-sicherheit oder die Datenqualität beeinflussen könnte
    - Blutspende innerhalb der letzten 2 Monate
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of Acute Mountain Sickness
    Inzidenz der Akuten Bergkrankheit
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 48 h at 4559 m
    Nach 48 Std auf 4559 m
    E.5.2Secondary end point(s)
    1. Severity of Acute Mountain Sickness
    2. Relationship between severity of Acute Mountain Sickness and budenoside plasma levels
    1. Schweregrad der Akuten Bergkrankheit
    2. Quantitative Assoziation zwischen Schweregrad der Akuten Bergkrankheit und Budesonid-Plasmakonzentration
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 48 h at 4559 m
    Nach 48 Std auf 4559 m
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days11
    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: 51
    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 Yes
    F.3.2Patients No
    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 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 state51
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 51
    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)
    After termination of the trial, we will contact the subjects by phone to evaluate the general state of health and potential side-effects.
    Nach Abschluss der Studie werden die Probanden nochmals telefonisch kontaktiert bezüglich Allgemeinzustand und möglichen Nebenwirkungen.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-31
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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