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    Clinical Trial Results:
    TARGETING OF THE SMALL AIRWAYS IN PATIENTS WITH COPD: AIRWAY EFFECTS OF TIOTROPIUM -Respimat vs. Handihaler

    Summary
    EudraCT number
    		 2015-001615-13
    Trial protocol
    		 GB  
    Global end of trial date
    11 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Oct 2019
    First version publication date
    19 Oct 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    151C2697
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02683668
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    South Kensington Campus, London, United Kingdom, SW7 2AZ
    Public contact
    Dr Omar Usmani, Imperial College London, +44 (0)20 7351 8051, o.usmani@imperial.ac.uk
    Scientific contact
    Dr Omar Usmani, Imperial College London, +44 (0)20 7351 8051, o.usmani@imperial.ac.uk
    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
    07 Jan 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Jan 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Our principle objective is to investigate the effect of tiotropium (a long-acting inhaled bronchodilator), delivered from different devices, on a panel of small (IOS, MBNW, DLCO, FVC) and large airway (FEV1, PEF) responses in patients with mild-moderate COPD. We will compare equivalent doses of Titropium from Respimat (Tiotropium Respimat 5 micrograms once daily), a small particle soft mist inhaler (SMI) compared to delivering it from Handihaler (18 micrograms once daily), a standard large particle dry powder inhaler (DPI). Respimat is a novel inhaler platform that has small particles and a slow inhalation allowing deeper lung drug delivery. We will be using easily performed non-invasive breathing tests to measure response: • Impulse Oscillometry (IOS) parameters • Multiple Nitrogen Washout parameters (MBNW) • Lung function test (LFT) parameters: We will also assess the safety and tolerability, as determined by vital signs of heart rate and blood pressure.
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2015
    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
    United Kingdom: 44
    Worldwide total number of subjects
    44
    EEA total number of subjects
    44
    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)
    12
    From 65 to 84 years
    32
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participant were recruited at Royal Brompton Hospital between February 2016 and January 2018

    Pre-assignment
    Screening details
    		 A total of 47 participant were screened, 3 excluded due to not meet the inclusion criteria

    Period 1
    Period 1 title
    Phase 0
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All participant
    Arm description
    		 All participants treated with HandiHaler 18mcg Tiotropium, no training for the participants
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tiotropium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    18ug daily

    Number of subjects in period 1
    		All participant
    Started
    44
    Completed
    44
    Period 2
    Period 2 title
    Phase 1
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All participant
    Arm description
    		 All participant treated with HandiHaler 18ug Tiotropium daily. training provided for participants
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tiotropium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    18ug daily

    Number of subjects in period 2
    		All participant
    Started
    44
    Completed
    43
    Not completed
    1
         Consent withdrawn by subject
    1
    Period 3
    Period 3 title
    phase 2
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All participant
    Arm description
    		 All participants treated with Respimat 5mcg Tiotropium, no training for the participants
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tiotropium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    5ug daily

    Number of subjects in period 3
    		All participant
    Started
    43
    Completed
    43

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Phase 0
    Reporting group description
    		 -

    Reporting group values
    		 Phase 0 Total
    Number of subjects
    		 44 44
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 12 12
        From 65-84 years
    		 32 32
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 69.1 ( 8.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 21 21
        Male
    		 23 23
    R5-R20 Peripheral Airways Resistance
    Units: kPal/s
        arithmetic mean (standard deviation)
    		 0.608 ( 0.207 ) -

    End points

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    End points reporting groups
    Reporting group title
    All participant
    Reporting group description
    		 All participants treated with HandiHaler 18mcg Tiotropium, no training for the participants
    Reporting group title
    All participant
    Reporting group description
    		 All participant treated with HandiHaler 18ug Tiotropium daily. training provided for participants
    Reporting group title
    All participant
    Reporting group description
    		 All participants treated with Respimat 5mcg Tiotropium, no training for the participants

    Primary: R5-R20

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    End point title
    		 R5-R20 [1]
    End point description
    End point type
    Primary
    End point timeframe
    6 months
    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: Statistical analyses ongoing, end date is January 2020.
    End point values
    		 All participant All participant All participant
    Number of subjects analysed
    44
    43
    43
    Units: kPal/s
        arithmetic mean (standard deviation)
    0.608 ( 0.207 )
    0.589 ( 0.169 )
    0.497 ( 0.148 )
    No statistical analyses for this end point

    Primary: Sacin

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    End point title
    		 Sacin [2]
    End point description
    After treatment IMPULSE Oscillometry
    End point type
    Primary
    End point timeframe
    14 days
    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: Statistical analyses ongoing, end date is January 2020.
    End point values
    		 All participant All participant All participant
    Number of subjects analysed
    44
    43
    43
    Units: kPal\s
        arithmetic mean (standard deviation)
    0.333 ( 0.103 )
    0.339 ( 0.119 )
    0.345 ( 0.134 )
    No statistical analyses for this end point

    Primary: Lung function FEV1

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    End point title
    		 Lung function FEV1 [3]
    End point description
    End point type
    Primary
    End point timeframe
    14 days
    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: Statistical analyses ongoing, end date is January 2020.
    End point values
    		 All participant All participant All participant
    Number of subjects analysed
    44
    43
    43
    Units: litre(s)
        arithmetic mean (standard deviation)
    1.575 ( 0.483 )
    1.571 ( 0.523 )
    1.651 ( 0.497 )
    No statistical analyses for this end point

    Secondary: Multi-Breath Washout Test (MBW)

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    End point title
    		 Multi-Breath Washout Test (MBW)
    End point description
    End point type
    Secondary
    End point timeframe
    14 days
    End point values
    		 All participant All participant All participant
    Number of subjects analysed
    44
    43
    43
    Units: kPal/s
        arithmetic mean (standard deviation)
    0.047 ( 0.042 )
    0.042 ( 0.032 )
    0.036 ( 0.032 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    3 months
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    All participant
    Reporting group description
    		 -

    Serious adverse events
    		 All participant
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 44 (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
    		 All participant
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 44 (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 event were detected on the trial.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Nov 2015
    Modify Participant consent form, Participant information sheet (PIS).
    01 Sep 2016
    We request a change in one of the exclusion criteria of our study protocol.

    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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