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    Clinical Trial Results:
    The influence of exercise and hydration to the pharmacological response to inhaled terbutalin and salbutamol in men

    Summary
    EudraCT number
    		 2013-000483-29
    Trial protocol
    		 DK  
    Global end of trial date
    28 Aug 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Feb 2017
    First version publication date
    09 Feb 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Wada_2012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bispebjerg University Hospital
    Sponsor organisation address
    Bispebjerg Bakke 23, Copenhagen, Denmark, 2400
    Public contact
    Respiratory Research Unit, Bispebjerg University Hospital, mhostrup@nexs.ku.dk
    Scientific contact
    Respiratory Research Unit, Bispebjerg University Hospital, mhostrup@nexs.ku.dk
    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
    17 Mar 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Aug 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Aug 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the pharmacokinetic effekt of the medicine under physical work and dehydration in healthy men
    Protection of trial subjects
    Safety of the trial subjects was high prioritized. All procedures are well tolerated and at risk periods, the subjects were under surveillance so that a member of staff could intervene if needed. The study was performed under the GCP-guidelines.
    Background therapy
    		 None
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 May 2014
    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
    Denmark: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment started on the 11th of September 2013 and ended on the 01st of july 2014. Recruitment took place in Denmark, mostly in the greater Copenhagen area.

    Pre-assignment
    Screening details
    		 Screening consisted of # Doctors examination # ECG and pulmonary function testing # incremental test

    Pre-assignment period milestones
    Number of subjects started
    		 30
    Number of subjects completed
    		 30

    Period 1
    Period 1 title
    Intervention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Salbutamol
    Arm description
    		 Active substance: salbutamol
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ventoline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    The subjects inhale 2x800 µg ventoline at either V1 or V2. At the other visit the subject recieves placebo. At visit 3 and 4 the subjects inhale 2x800 µg ventoline.

    Arm title
    		 Terbutaline
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Terbutaline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    8x 0.5 mg

    Number of subjects in period 1
    		Salbutamol Terbutaline
    Started
    15
    15
    Completed
    15
    13
    Not completed
    0
    2
         Protocol deviation
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Salbutamol
    Reporting group description
    		 Active substance: salbutamol

    Reporting group title
    Terbutaline
    Reporting group description
    		 -

    Reporting group values
    		 Salbutamol Terbutaline Total
    Number of subjects
    		 15 15 30
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 15 15 30
    Gender categorical
    Units: Subjects
        Male
    		 15 15 30

    End points

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    End points reporting groups
    Reporting group title
    Salbutamol
    Reporting group description
    		 Active substance: salbutamol

    Reporting group title
    Terbutaline
    Reporting group description
    		 -

    Primary: Urine concentrations of terbutaline

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    End point title
    		 Urine concentrations of terbutaline
    End point description
    End point type
    Primary
    End point timeframe
    During whole trial
    End point values
    		 Salbutamol Terbutaline
    Number of subjects analysed
    15
    13
    Units: ng/ml
        number (not applicable)
    15
    13
    Statistical analysis title
    		 Repeated-measures analysis
    Statistical analysis description
    Three factorial repeated-measures analysis of variance mixed linear model
    Comparison groups
    Salbutamol v Terbutaline
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During the whole trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Nathional authority
    Dictionary version
    x
    Reporting groups
    Reporting group title
    Salbutamol
    Reporting group description
    		 Active substance: salbutamol

    Reporting group title
    Terbutaline
    Reporting group description
    		 -

    Serious adverse events
    		 Salbutamol Terbutaline
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Salbutamol Terbutaline
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (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 non-serious adverse events were recorded

    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/27167471
    http://www.ncbi.nlm.nih.gov/pubmed/26044066
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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