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    Clinical Trial Results:
    An Open Label Oxygen Enhanced Imaging Biomarker Study to Assess the Role of Fluticasone/Formoterol upon Airway Function in Moderate to Severe Persistent Asthma.

    Summary
    EudraCT number
    		 2015-000172-98
    Trial protocol
    		 GB  
    Global end of trial date
    31 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jan 2020
    First version publication date
    03 Jan 2020
    Other versions
    Summary report(s)
    		 study summary data tables
    patient level data

    Trial information

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    Trial identification
    Sponsor protocol code
    2015-000172-98
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Leicester
    Sponsor organisation address
    Gwendolen Road, Leicester, United Kingdom, LE5 4PW
    Public contact
    Salman Siddiqui, University Hospitals of Leicester NHS Trust, 0044 01162586841, ss338@le.ac.uk
    Scientific contact
    Salman Siddiqui, University Hospitals of Leicester NHS Trust, 0044 01162586841, ss338@le.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 Oct 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Inhaled Fluticasone/Formoterol improves both large and small airway function in moderate to severe persistent asthma. The primary objective of this study is to demonstrate a statistically significant change in both OE-MRI imaging biomarkers [oxygen exponential washout time (Tdown) and major airway ventilation (Tvent) time] using dynamic OE-MRI in moderate-to-severe asthmatics, within 30 minutes of administration of two observed inhalations via spacer of Fluticasone/Formoterol [250/10].
    Protection of trial subjects
    All patients were given detailed information on Oe-MRI, had pre MRI safety questionnaires and were in regular communication with the MRI radiographers during the MRI scans.
    Background therapy
    		 Controller medications used for moderate to severe persistent asthma.
    Evidence for comparator
    		 Single MRI analyst blind and open label study
    Actual start date of recruitment
    01 Jan 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: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Single centre recruitment, Glenfield Hospital, Leicester, UK. All patients were identified and recruited from secondary care asthma clinics.

    Pre-assignment
    Screening details
    		 The study population includes male and female symptomatic patients with moderate-to-severe adult asthma (GINA 3-4).In addition patients selected had evidence of fixed spirometric airflow obstruction based upon post bronchodilator spirometry, to maximise the probability of small airways disease.

    Pre-assignment period milestones
    Number of subjects started
    		 16
    Number of subjects completed
    		 16

    Period 1
    Period 1 title
    pre FP/FORM
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Oe-MRI analysts were blinded to MRI scan sequence (pre vs post FP/FORM)

    Arms
    Arm title
    		 pre FP/FORM
    Arm description
    		 pre inhalation of FP/FORM
    Arm type
    		 pre FP/FORM inhalation

    Investigational medicinal product name
    fluticasone prioprionate/formoterol fumarate [FP/FORM, 250/10 μg]
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension and solution for spray
    Routes of administration
    Inhalation use
    Dosage and administration details
    250/10 μg , two inhalations, via an aerochamber

    Number of subjects in period 1
    		pre FP/FORM
    Started
    16
    Completed
    16
    Period 2
    Period 2 title
    30 minutes Post FP/FORM
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Oe-MRI analysts were blinded to MRI scan sequence (pre vs post FP/FORM)

    Arms
    Arm title
    		 Post FP/FORM
    Arm description
    		 30 minutes post inhalation of FP/FORM
    Arm type
    		 Experimental

    Investigational medicinal product name
    fluticasone prioprionate/formoterol fumarate [FP/FORM, 250/10 μg]
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension and solution for spray
    Routes of administration
    Inhalation use
    Dosage and administration details
    250/10 μg , two inhalations, via an aerochamber

    Number of subjects in period 2
    		Post FP/FORM
    Started
    16
    Completed
    16

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    pre FP/FORM
    Reporting group description
    		 -

    Reporting group values
    		 pre FP/FORM Total
    Number of subjects
    		 16 16
    Age categorical
    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)
    		 12 12
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    pre FP/FORM
    Reporting group description
    		 pre inhalation of FP/FORM
    Reporting group title
    Post FP/FORM
    Reporting group description
    		 30 minutes post inhalation of FP/FORM

    Primary: Tvent - whole lung

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    End point title
    		 Tvent - whole lung
    End point description
    whole lung median Tvent
    End point type
    Primary
    End point timeframe
    pre and 30 minutes post FP/FORM inhalation
    End point values
    		 pre FP/FORM Post FP/FORM
    Number of subjects analysed
    16
    16
    Units: seconds
        median (inter-quartile range (Q1-Q3))
    53.3 (47.6 to 60.2)
    50.0 (37.2 to 55.9)
    Attachments
    		 Tvent data
    Statistical analysis title
    		 Tvent analysis
    Statistical analysis description
    pre vs post FP/FORM analysis
    Comparison groups
    pre FP/FORM v Post FP/FORM
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 = 0.05
    Method
    		 Wilcoxon signed-rank test
    Confidence interval
    Notes
    [1] - paired analysis

    Primary: Tdown

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    End point title
    		 Tdown
    End point description
    whole lung median Tdown
    End point type
    Primary
    End point timeframe
    pre and 30 minutes post FP/FORM inhalation
    End point values
    		 pre FP/FORM Post FP/FORM
    Number of subjects analysed
    16
    16
    Units: minutes
        median (inter-quartile range (Q1-Q3))
    1.29 (1.17 to 1.69)
    1.27 (1.08 to 1.43)
    Attachments
    		 Tdown data
    Statistical analysis title
    		 Tvent
    Statistical analysis description
    analysis of the change in Tvent 30 minutes following FP/FORM inhalation
    Comparison groups
    pre FP/FORM v Post FP/FORM
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.17
    Method
    		 Wilcoxon signed-rank test
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All SAEs, except those expected (as defined in the trial protocol) that do not require immediate reporting were required to be reported to the Sponsor within one working day of discovery or notification of the event
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Mannual
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Trial partipants that competed study screening
    Reporting group description
    		 Participant that were screened for the study and an entered the study specific assessments

    Serious adverse events
    		 Trial partipants that competed study screening
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (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
    		 Trial partipants that competed study screening
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 16 (6.25%)
    Respiratory, thoracic and mediastinal disorders
    chest infection
    Additional description: Mild to Moderate chest infection in a single participant, deemed unlikely to be causality related to the IMP. start date: 20-05-2015 end date: 15-06-2016
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Mar 2017
    Sample size was increased from 12 to a minimum of 15 participants to enable meaningful analysis and reporting of additional Oe-MRI secondary endpoints (EoxFb and Kox). Ethical approval was gained to screen an additional 6 participants to allow for screen failures.

    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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