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    Clinical Trial Results:
    Bronkial respons på inhaleret Mannitol

    Summary
    EudraCT number
    		 2007-003765-40
    Trial protocol
    		 DK  
    Global end of trial date
    01 Jul 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Aug 2022
    First version publication date
    17 Aug 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2007-003765-40
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bispebjerg Hospital
    Sponsor organisation address
    Bispebjerg Bakke 23, Copenhagen, Denmark, 2400
    Public contact
    Asger Sverrild, Bispebjerg Hospital Department of Respiratory Medicine and Infectious Diseases, 45 26259961, asger.sverrild@regionh.dk
    Scientific contact
    Asger Sverrild, Bispebjerg Hospital Department of Respiratory Medicine and Infectious Diseases, 45 26259961, asger.sverrild@regionh.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
    08 Aug 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jul 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jul 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. Frequency of asthma 2. Frequency of AHR to mannitol and methacholine 3. Association between AHR to mannitol and methacholine
    Protection of trial subjects
    Subjects were examined in a hospital setting following international clinical practices for all investigations
    Background therapy
    		 None specific required
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Feb 2007
    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: 238
    Worldwide total number of subjects
    238
    EEA total number of subjects
    238
    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)
    91
    Adults (18-64 years)
    147
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was a population study - An unselected sample of 1000 young adults between the ages of 14 and 24 years was randomly drawn from the civil registration list

    Pre-assignment
    Screening details
    		 This was a population study - An unselected sample of 1000 young adults between the ages of 14 and 24 years was randomly drawn from the civil registration list

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 full population
    Arm description
    		 all participants in the trial had the same investigations perfomred studying the performance of inhaled mannitol as a diagnostic tool for astma
    Arm type
    		 Experimental

    Investigational medicinal product name
    mannitol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    FEV1 recorded after inhalation of a 0-mg placebo capsule constituted baseline lung function. The challenge was stopped at a decrease in FEV1 of 15% or greater from baseline values or when the maximum cumulative dose of 635 mg had been administered

    Number of subjects in period 1
    		full population
    Started
    238
    Completed
    238

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    full population
    Reporting group description
    		 all participants in the trial had the same investigations perfomred studying the performance of inhaled mannitol as a diagnostic tool for astma

    Subject analysis set title
    Diagnostic properties of inhaled mannitol and methacholine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Diagnostic properties of AHR to inhaled mannitol and methacholine in the assessment of asthma in an unselected sample of young adults

    Primary: Asthma prevalence

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    End point title
    		 Asthma prevalence [1]
    End point description
    Asthma prevalence in an unselected samples of Danish young adults
    End point type
    Primary
    End point timeframe
    5th of Feb 2007 to 5th of April 2008
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: patients with a diagnosis of asthma out of the whole study population
    End point values
    		 Diagnostic properties of inhaled mannitol and methacholine
    Number of subjects analysed
    238
    Units: percent
        number (not applicable)
    21.4
    No statistical analyses for this end point

    Primary: Sensitivity - inhaled mannitol

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    End point title
    		 Sensitivity - inhaled mannitol [2]
    End point description
    Sensitivity and Specificity of inhaled mannitol in diagnosing asthma in a random population sample
    End point type
    Primary
    End point timeframe
    5th of Feb 2007 to 5th of April 2008
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: A receiver operating characteristic (ROC) curve was constructed, plotting RDRs to mannitol and methacholine against the diagnosis of asthma. The overall accuracy of the test was measured as the area under the ROC curve. Sensitivity and Specificity were calculated
    End point values
    		 Diagnostic properties of inhaled mannitol and methacholine
    Number of subjects analysed
    238
    Units: percent
        number (confidence interval 95%)
    58.8 (50.7 to 62.6)
    No statistical analyses for this end point

    Primary: Sensitivity - methacholine

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    End point title
    		 Sensitivity - methacholine [3]
    End point description
    Sensitivity and Specificity of inhaled methacholine in an unselected sample of Danish young adults
    End point type
    Primary
    End point timeframe
    5th of Feb 2007 to 5th of April 2008
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: A receiver operating characteristic (ROC) curve was constructed, plotting RDRs to mannitol and methacholine against the diagnosis of asthma. The overall accuracy of the test was measured as the area under the ROC curve. Sensitivity and Specificity were calculated
    End point values
    		 Diagnostic properties of inhaled mannitol and methacholine
    Number of subjects analysed
    238
    Units: percent
        number (confidence interval 95%)
    69 (57 to 78)
    No statistical analyses for this end point

    Primary: Specificity - inhaled mannitol

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    End point title
    		 Specificity - inhaled mannitol [4]
    End point description
    Specificity of inhaled mannitol in diagnosing asthma in a random population sample of young adults
    End point type
    Primary
    End point timeframe
    5th of Feb 2007 to 5th of April 2008
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: A receiver operating characteristic (ROC) curve was constructed, plotting RDRs to mannitol and methacholine against the diagnosis of asthma. The overall accuracy of the test was measured as the area under the ROC curve. Sensitivity and Specificity were calculated
    End point values
    		 Diagnostic properties of inhaled mannitol and methacholine
    Number of subjects analysed
    238
    Units: percent
        number (confidence interval 95%)
    98.4 (96.2 to 99.4)
    No statistical analyses for this end point

    Primary: Specificity - methacholine

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    End point title
    		 Specificity - methacholine [5]
    End point description
    Specificity of methacholine in diagnosing asthma in a random population sample of young adults
    End point type
    Primary
    End point timeframe
    5th of Feb 2007 to April 2008
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: A receiver operating characteristic (ROC) curve was constructed, plotting RDRs to mannitol and methacholine against the diagnosis of asthma. The overall accuracy of the test was measured as the area under the ROC curve. Sensitivity and Specificity were calculated.
    End point values
    		 Diagnostic properties of inhaled mannitol and methacholine
    Number of subjects analysed
    238
    Units: percent
        number (confidence interval 95%)
    80 (77 to 83)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    5th of Feb 2007 to 4th of April 2008
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.1
    Frequency threshold for reporting non-serious adverse events: 5%
    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: Cough was repored as an expected non-serious adverse event in the majority

    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
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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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