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    Clinical Trial Results:
    The RECONSTRUCT study Reconstructing Disease Mechanisms in Asthma

    Summary
    EudraCT number
    		 2016-003509-33
    Trial protocol
    		 DK  
    Global end of trial date
    01 Apr 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Apr 2021
    First version publication date
    02 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RECONSTRUCT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Lungemedicinsk Forskningsenhed, Bispebjerg Hospital
    Sponsor organisation address
    Bispebjerg bakke 23, indgang 66, København NV, Denmark, 2400
    Public contact
    Lungemedicinsk Forskningsenhed, Lungemedicinsk Forskningsenhed, Bispebjerg Hospital, +45 60770127, morten.hvidtfeldt@regionh.dk
    Scientific contact
    Lungemedicinsk Forskningsenhed, Lungemedicinsk Forskningsenhed, Bispebjerg Hospital, +45 60770127, morten.hvidtfeldt@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
    17 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Apr 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Apr 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the correlation between increase in ASM content of Na+, K+ pumps and reduction in airway hyperresponsiveness to mannitol after six weeks of daily inhalation of glucocorticoid, in patients with asthma and to describe differences in ASM content of Na+, K+ pumps among healthy subjects and patients with non-eosinophilic asthma (NEA) or eosinophilic asthma (EA) respectively. Primary endpoint:
    Protection of trial subjects
    Trial subjects were monitored closely once weekly by phone
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Mar 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    60
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited continuously

    Pre-assignment
    Screening details
    		 Non-smoking patients with asthma and airway hyperresponsiveness to mannitol not currently on inhaled corticosteroids.

    Period 1
    Period 1 title
    Intervention
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Type 2 high asthma
    Arm description
    		 Type 2 high asthma based on FeNO > 25 ppb
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Budesonide
    Investigational medicinal product code
    Other name
    Spirocort
    Pharmaceutical forms
    Inhalation powder, pre-dispensed
    Routes of administration
    Inhalation use
    Dosage and administration details
    1600 ug daily

    Arm title
    		 Type 2 low asthma
    Arm description
    		 Type 2 low asthma based on FeNO < 25 ppb
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Budesonide
    Investigational medicinal product code
    Other name
    Spirocort
    Pharmaceutical forms
    Inhalation powder, pre-dispensed
    Routes of administration
    Inhalation use
    Dosage and administration details
    1600 ug daily

    Number of subjects in period 1 [1]
    		Type 2 high asthma Type 2 low asthma
    Started
    25
    25
    Completed
    25
    21
    Not completed
    0
    4
         Consent withdrawn by subject
    -
    4
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: -
    Period 2
    Period 2 title
    Healthy controls
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Healthy controls
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2 [2]
    		Healthy controls
    Started
    10
    Completed
    10
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 -

    Reporting group values
    		 Intervention Total
    Number of subjects
    		 50 50
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 24 (20 to 28) -
    Gender categorical
    Units: Subjects
        Female
    		 25 25
        Male
    		 25 25
    Subject analysis sets

    Subject analysis set title
    Type 2 high asthma
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Type 2 high asthma with FeNO>25 ppb at baseline

    Subject analysis set title
    Type 2 low asthma
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Type 2 low asthma with FeNO<25 ppb at baseline

    Subject analysis sets values
    		 Type 2 high asthma Type 2 low asthma
    Number of subjects
    25
    25
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    26 (21 to 31)
    23 (19 to 27)
    Gender categorical
    Units: Subjects
        Female
    11
    14
        Male
    14
    11

    End points

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    End points reporting groups
    Reporting group title
    Type 2 high asthma
    Reporting group description
    		 Type 2 high asthma based on FeNO > 25 ppb

    Reporting group title
    Type 2 low asthma
    Reporting group description
    		 Type 2 low asthma based on FeNO < 25 ppb
    Reporting group title
    Healthy controls
    Reporting group description
    		 -

    Subject analysis set title
    Type 2 high asthma
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Type 2 high asthma with FeNO>25 ppb at baseline

    Subject analysis set title
    Type 2 low asthma
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Type 2 low asthma with FeNO<25 ppb at baseline

    Primary: Airway hyperresponsiveness

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    End point title
    		 Airway hyperresponsiveness
    End point description
    Doubling dose of PD15 to mannitol
    End point type
    Primary
    End point timeframe
    Before and after intervention
    End point values
    		 Type 2 high asthma Type 2 low asthma Type 2 high asthma Type 2 low asthma
    Number of subjects analysed
    25
    21
    25
    21
    Units: Doubling dose
        geometric mean (confidence interval 95%)
    3.98 (2.49 to 6.38)
    3.85 (2.51 to 5.91)
    3.98 (2.49 to 6.38)
    3.85 (2.51 to 5.91)
    Statistical analysis title
    		 Difference in change in AHR
    Comparison groups
    Type 2 high asthma v Type 2 low asthma
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.92
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During study period
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 46 (2.17%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    psychiatric admission
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 46 (2.17%)
    Immune system disorders
    Asthma exacerbation, mild
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences all number
    1

    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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