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    Clinical Trial Results:
    Effect of Dual Bronchodilatation on Broncholysis Testing in COPD Patients

    Summary
    EudraCT number
    		 2014-002667-15
    Trial protocol
    		 AT  
    Global end of trial date
    17 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Nov 2020
    First version publication date
    21 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    05201401
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Innsbruck
    Sponsor organisation address
    Christoph-Probst-Platz 1, Innrain 52 A, Innsbruck, Austria, 6020
    Public contact
    Katarzyna Wachowicz, Medical university Innsbruck, University Hospital for Internal Medicine II (Pneumology) , +43 51250423258, Katarzyna.Wachowicz@i-med.ac.at
    Scientific contact
    Katarzyna Wachowicz, Medical university Innsbruck, University Hospital for Internal Medicine II (Pneumology) , +43 51250423258, Katarzyna.Wachowicz@i-med.ac.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
    17 Dec 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    A change in the FEV1 parameter (Forced Expiratory Pressure in 1 Second) value in an acute broncholysis testing (pre-brochnolysis versus post-broncholysis) is supposed to distinguish between COPD and asthmatic patients. The aim of this study is to compare the effects of a dual bronchodilator (glycopyrronium 43 µg / indacaterol 85 µg) with a standard short-acting bronchodilator (salbutamol) on changes in the FEV1 values.
    Protection of trial subjects
    N/A
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Sep 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
    Austria: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    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)
    99999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No patients were recruited for this trial. "99999" is a value for 0 participants.

    Pre-assignment
    Screening details
    		 N/A

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

    Arms
    Arm title
    		 Salbutamol/ Ultibro
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ultibro Breezhaler
    Investigational medicinal product code
    Other name
    indacaterol maleate / glycopyrronium bromide
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Inhalation of Glykopyronium 43 microgram / 85 microgram indacaterol

    Investigational medicinal product name
    Salbutamol Sandoz
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Inhalation of salbutamol 0.2 mg (2 puffs - Salbutamol Sandoz 100 micrograms) nebulized with the help of a spacer.

    Number of subjects in period 1
    		Salbutamol/ Ultibro
    Started
    99999
    Completed
    99999

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 99999 99999
    Age categorical
    "99999" is a value for 0 participants.
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 99999 99999
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    "99999" is a value for 0 participants.
    Units: years
        arithmetic mean (standard deviation)
    		 0 ( 0 ) -
    Gender categorical
    "99999" is a value for 0 participants.
    Units: Subjects
        Female
    		 99999 99999
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Salbutamol/ Ultibro
    Reporting group description
    		 -

    Primary: Change of FEV1 compared to baseline

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    End point title
    		 Change of FEV1 compared to baseline [1]
    End point description
    End point type
    Primary
    End point timeframe
    N/A
    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: No subjects were included in this trial, therefore no statistical analysis was done.
    End point values
    		 Salbutamol/ Ultibro
    Number of subjects analysed
    99999 [2]
    Units: FEV
        number (not applicable)
    99999
    Notes
    [2] - "99999" is a value for 0 participants
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    15.9.2014-17.12.2014
    Adverse event reporting additional description
    No patients were included in this trial, therefore o AEs and SAEs were observed.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Salbutamol/ Ultibro
    Reporting group description
    		 -

    Serious adverse events
    		 Salbutamol/ Ultibro
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Salbutamol/ Ultibro
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 99999 (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 patients were included in this trial, therefore no AEs or SAEs were obsered,

    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.
    No subjects were enrolled in this trial. "99999" is a value for 0 participants , as it was not possible to fill in "0" for the number of included patients.
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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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