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    Clinical Trial Results:
    Effect of inhaled budenoside on the incidence and severity of Acute Mountain Sickness at 4559 m

    Summary
    EudraCT number
    		 2016-000160-42
    Trial protocol
    		 AT  
    Global end of trial date
    29 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Sep 2019
    First version publication date
    21 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M2016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UK für Anästhesiologie und allgemeine Intensivmedizin
    Sponsor organisation address
    Müllner Hauptstr. 48, Salzburg, Austria, 5020
    Public contact
    Sekretariat, UK für Anästhesiologie und allgemeine Intensivmedizin, 0043 5725524001, ma.berger@salk.at
    Scientific contact
    Sekretariat, UK für Anästhesiologie und allgemeine Intensivmedizin, 0043 5725524001, ma.berger@salk.at
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Dec 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Does inhaled budenoside reduce the incidence of AMS after rapid and active ascent to 4559 m?
    Protection of trial subjects
    Daily assessment of health status, 24/7 availability of investigators for subjects
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 May 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    50
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 physical fitness (VO2max)

    Pre-assignment period milestones
    Number of subjects started
    		 51 [1]
    Number of subjects completed
    		 51

    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 1 dropout due to personal reasons after pre-investigation was completed
    Period 1
    Period 1 title
    High Altitude Part
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    PL1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo T.I.D.

    Arm title
    		 B200
    Arm description
    		 Budesonide 200µg
    Arm type
    		 Active comparator

    Investigational medicinal product name
    PR1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    200µg T.I.D.

    Arm title
    		 B800
    Arm description
    		 Budesonide 800µg
    Arm type
    		 Active comparator

    Investigational medicinal product name
    PR2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Budesonide 800µg T.I.D.

    Number of subjects in period 1
    		Placebo B200 B800
    Started
    17
    17
    17
    Starting high altitude part
    17
    17
    17
    Completed
    17
    16
    17
    Not completed
    0
    1
    0
         Personal reasons
    -
    1
    -
    Period 2
    Period 2 title
    Pre-investigation
    Is this the baseline period?
    		 Yes [2]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    PL1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo T.I.D.

    Arm title
    		 B200
    Arm description
    		 PR1
    Arm type
    		 Active comparator

    Investigational medicinal product name
    PR1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Budesonide 200µg T.I.D.

    Arm title
    		 B800
    Arm description
    		 B800/PR2
    Arm type
    		 Active comparator

    Investigational medicinal product name
    PR2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Budesonide 800µg T.I.D.

    Notes
    [2] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: We mixed up the order while entering the data. We entered the high altitude data prior to the baseline investigation data.
    Number of subjects in period 2
    		Placebo B200 B800
    Started
    17
    16
    17
    Completed
    17
    16
    17

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    B200
    Reporting group description
    		 PR1

    Reporting group title
    B800
    Reporting group description
    		 B800/PR2

    Reporting group values
    		 Placebo B200 B800 Total
    Number of subjects
    		 17 16 17 50
    Age categorical
    Adults 18-65
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 17 16 17 50
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36 ± 12 38 ± 11 38 ± 11 -
    Gender categorical
    Units: Subjects
        Female
    		 6 4 6 16
        Male
    		 11 12 11 34
    VO2max
    Watt/kg
    Units: Subjects
        VO2max
    		 17 16 17 50
    AMS
    Acute Mountain Sickness
    Units: not applicable
        arithmetic mean (standard deviation)
    		 ± ± ± -
    Subject analysis sets

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo

    Subject analysis set title
    B200
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Budesonide 200µg

    Subject analysis set title
    B800
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Budesonide 800µg

    Subject analysis sets values
    		 Placebo B200 B800
    Number of subjects
    17
    16
    17
    Age categorical
    Adults 18-65
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    17
    16
    17
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    36 ± 12
    38 ± 11
    38 ± 11
    Gender categorical
    Units: Subjects
        Female
    6
    4
    6
        Male
    11
    12
    11
    VO2max
    Watt/kg
    Units: Subjects
        VO2max
    17
    16
    17
    AMS
    Acute Mountain Sickness
    Units: not applicable
        arithmetic mean (standard deviation)
    0.03 ± 0.14
    0.84 ± 0.89
    ±

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    B200
    Reporting group description
    		 Budesonide 200µg

    Reporting group title
    B800
    Reporting group description
    		 Budesonide 800µg
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    B200
    Reporting group description
    		 PR1

    Reporting group title
    B800
    Reporting group description
    		 B800/PR2

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo

    Subject analysis set title
    B200
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Budesonide 200µg

    Subject analysis set title
    B800
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Budesonide 800µg

    Primary: AMS - Incidence

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    End point title
    		 AMS - Incidence
    End point description
    End point type
    Primary
    End point timeframe
    during 3 days at high altitude
    End point values
    		 Placebo B200 B800
    Number of subjects analysed
    17
    16
    17
    Units: full numbers
        AMS positive
    9
    9
    13
        AMS negative
    8
    7
    4
    Statistical analysis title
    		 Incidence AMS
    Comparison groups
    Placebo v B200 v B800
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared corrected
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    whole study duration
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    B200
    Reporting group description
    		 Budesonide 200µg

    Reporting group title
    B800
    Reporting group description
    		 Budesonide 800µg

    Serious adverse events
    		 Placebo B200 B800
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Placebo B200 B800
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse events to report.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28890439
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