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    Clinical Trial Results:
    A Randomized, Double-blind, Two Treatment, Two Period, Chronic Dosing (4 weeks), Cross-Over, Multi-Center Pilot Study to Evaluate the Effects of Budesonide/Glycopyrronium/Formoterol Fumarate and Glycopyrronium/Formoterol Fumarate on Specific Image-based Airway Volumes and Resistance in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease

    Summary
    EudraCT number
    		 2018-001704-10
    Trial protocol
    		 NL   BE  
    Global end of trial date
    11 Nov 2019

    Results information
    Results version number
    		 v2(current)
    This version publication date
    10 Feb 2021
    First version publication date
    27 Nov 2020
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    D5980C00019
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    Pepparedsleden 1, Molndal, Sweden,
    Public contact
    Magnus Aurivillius, AstraZeneca AB, magnus.aurivillius@astrazeneca.com
    Scientific contact
    Magnus Aurivillius, AstraZeneca AB, magnus.aurivillius@astrazeneca.com
    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
    16 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Nov 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effects of BGF MDI and GFF MDI on specific image-based airway volumes and resistance in subjects with moderate to severe COPD following chronic twice daily (BID) dosing after approximately 4 weeks of treatment.
    Protection of trial subjects
    Ventolin HFA was provided throughout the study for subjects to take as needed for relief of symptoms.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Feb 2019
    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
    Belgium: 7
    Country: Number of subjects enrolled
    Netherlands: 16
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    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)
    9
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study randomized 23 subjects at 4 study centers (1 center in Belgium and 3 centers in the Netherlands) from 26 February 2019 to 11 November 2019.

    Pre-assignment
    Screening details
    		 Subjects were randomized into 1 of 2 treatment sequences. Sequence 1 received BGF MDI in Period 1 followed by GFF MDI in Period 2. Sequence 2 received GFF MDI in Period 1 followed by BGF MDI in Period 2.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor
    Blinding implementation details
    All Subjects Randomized

    Arms
    Arm title
    		 Overall Study
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pressurised inhalation, suspension
    Routes of administration
    Inhalation use
    Dosage and administration details
    BGF MDI 320/14.4/9.6 μg

    Investigational medicinal product name
    Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pressurised inhalation, suspension
    Routes of administration
    Inhalation use
    Dosage and administration details
    GFF MDI 14.4/9.6 μg

    Number of subjects in period 1
    		Overall Study
    Started
    23
    Completed
    21
    Not completed
    2
         Adverse event, non-fatal
    1
         Protocol deviation
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 All Subjects Randomized

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 23 23
    Age Categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age <37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (≥40-<65 years)
    		 9 9
        Adults (≥65-<80 years)
    		 14 14
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.9 ( 7.6 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 18 18
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 0 0
        White
    		 23 23
        More than one race
    		 0 0
        Unknown or Not Reported
    		 0 0
    Subject analysis sets

    Subject analysis set title
    BGF MDI
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All Subjects Randomized

    Subject analysis set title
    GFF MDI
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All Subjects Randomized

    Subject analysis sets values
    		 BGF MDI GFF MDI
    Number of subjects
    22
    23
    Age Categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age <37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (≥40-<65 years)
    9
    9
        Adults (≥65-<80 years)
    13
    14
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    64.8 ( 7.8 )
    64.9 ( 7.6 )
    Gender Categorical
    Units: Subjects
        Female
    5
    5
        Male
    17
    18
    Race
    Units: Subjects
        American Indian or Alaska Native
    0
    0
        Asian
    0
    0
        Native Hawaiian or Other Pacific Islander
    0
    0
        Black or African American
    0
    0
        White
    22
    23
        More than one race
    0
    0
        Unknown or Not Reported
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 -

    Subject analysis set title
    BGF MDI
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All Subjects Randomized

    Subject analysis set title
    GFF MDI
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All Subjects Randomized

    Primary: Specific Image-based Airway Volume (siVaw)

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    End point title
    		 Specific Image-based Airway Volume (siVaw) [1]
    End point description
    Specific Image-based Airway Volume (siVaw) measured in mL/L. Average across lobes, adjusted for lobe volume. Reported as ratio to baseline.
    End point type
    Primary
    End point timeframe
    Baseline, Day 29
    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: According to the protocol, the primary analysis in this study was not a comparison between treatments, it was a comparison to baseline within each treatment. Therefore, no statistical analysis is included in this form as to only name a single treatment arm for each analysis generated validation errors. The estimates and confidence intervals for each comparison to baseline are however provided.
    End point values
    		 BGF MDI GFF MDI
    Number of subjects analysed
    20
    21
    Units: Ratio to baseline
        geometric mean (confidence interval 95%)
    1.72 (1.38 to 2.13)
    1.53 (1.28 to 1.83)
    No statistical analyses for this end point

    Primary: Specific Image-based Airway Resistance (siRaw)

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    End point title
    		 Specific Image-based Airway Resistance (siRaw) [2]
    End point description
    Specific Image-based Airway Resistance (siRaw) measured in kPa∙s. Average across lobes, adjusted for lobe volume. Reported as ratio to baseline.
    End point type
    Primary
    End point timeframe
    Baseline, Day 29
    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: According to the protocol, the primary analysis in this study was not a comparison between treatments, it was a comparison to baseline within each treatment. Therefore, no statistical analysis is included in this form as to only name a single treatment arm for each analysis generated validation errors. The estimates and confidence intervals for each comparison to baseline are however provided.
    End point values
    		 BGF MDI GFF MDI
    Number of subjects analysed
    20
    21
    Units: Ratio to baseline
        geometric mean (confidence interval 95%)
    0.50 (0.39 to 0.63)
    0.52 (0.40 to 0.67)
    No statistical analyses for this end point

    Secondary: Image-based Airway Volume (iVaw)

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    End point title
    		 Image-based Airway Volume (iVaw)
    End point description
    Image-based Airway Volume (iVaw) measured in mL. Average across lobes, without adjustment for lobe volume. Reported as ratio to baseline.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 29
    End point values
    		 BGF MDI GFF MDI
    Number of subjects analysed
    20
    21
    Units: Ratio to baseline
        geometric mean (confidence interval 95%)
    1.70 (1.37 to 2.11)
    1.51 (1.26 to 1.80)
    No statistical analyses for this end point

    Secondary: Image-based Airway Resistance (iRaw)

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    End point title
    		 Image-based Airway Resistance (iRaw)
    End point description
    Image-based Airway Resistance (iRaw) measured in kPa∙s/L. Average across lobes, without adjustment for lobe volume. Reported as ratio to baseline.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 29
    End point values
    		 BGF MDI GFF MDI
    Number of subjects analysed
    20
    21
    Units: Ratio to baseline
        geometric mean (confidence interval 95%)
    0.50 (0.40 to 0.63)
    0.52 (0.40 to 0.68)
    No statistical analyses for this end point

    Secondary: Forced Expiratory Volume in 1 Second (Post-dose FEV1)

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    End point title
    		 Forced Expiratory Volume in 1 Second (Post-dose FEV1)
    End point description
    Change from baseline in Forced Expiratory Volume in One Second (Post-dose FEV1)
    End point type
    Secondary
    End point timeframe
    Baseline, Day 29
    End point values
    		 BGF MDI GFF MDI
    Number of subjects analysed
    21
    21
    Units: Liters
        arithmetic mean (confidence interval 95%)
    0.346 (0.182 to 0.509)
    0.273 (0.140 to 0.405)
    No statistical analyses for this end point

    Secondary: Image-based Functional Residual Capacity (FRC)

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    End point title
    		 Image-based Functional Residual Capacity (FRC)
    End point description
    Change from baseline in Functional Residual Capacity (FRC).
    End point type
    Secondary
    End point timeframe
    Baseline, Day 29
    End point values
    		 BGF MDI GFF MDI
    Number of subjects analysed
    22
    21
    Units: Liters
        arithmetic mean (confidence interval 95%)
    -0.28 (-0.77 to 0.21)
    -0.50 (-0.81 to -0.18)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from Visit 2 throughout the treatment period and including the follow-up period telephone call.
    Adverse event reporting additional description
    The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment and for whom any post-dose data were available. Serious adverse events were collected from Visit 2 throughout the treatment period and including the follow-up period telephone call.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    BGF MDI
    Reporting group description
    		 Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation

    Reporting group title
    GFF MDI
    Reporting group description
    		 Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation

    Serious adverse events
    		 BGF MDI GFF MDI
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 23 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BGF MDI GFF MDI
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 23 (8.70%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2

    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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