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    Clinical Trial Results:
    A Randomized, Double-Blind, 12-Week (with an Extension to 52 Weeks in a subset of Participants), Multi-Center Study to Assess the Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO Compared to BGF delivered by MDI HFA in Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

    Summary
    EudraCT number
    		 2022-001476-33
    Trial protocol
    		 DE   PL   BG  
    Global end of trial date
    26 Mar 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Apr 2025
    First version publication date
    11 Apr 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D5985C00003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    151, 85 Södertälje, Sweden,
    Public contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@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
    10 Jun 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Mar 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Mar 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA over 12 to 52 weeks in participants with moderate to very severe COPD.
    Protection of trial subjects
    Immediate safety concerns should be discussed with the Sponsor immediately upon occurrence or awareness to determine if the participant should continue or discontinue study intervention.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Sep 2022
    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
    Argentina: 69
    Country: Number of subjects enrolled
    Canada: 72
    Country: Number of subjects enrolled
    Mexico: 18
    Country: Number of subjects enrolled
    United States: 111
    Country: Number of subjects enrolled
    Bulgaria: 55
    Country: Number of subjects enrolled
    Germany: 140
    Country: Number of subjects enrolled
    Poland: 71
    Country: Number of subjects enrolled
    Türkiye: 5
    Country: Number of subjects enrolled
    United Kingdom: 18
    Worldwide total number of subjects
    559
    EEA total number of subjects
    266
    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)
    177
    From 65 to 84 years
    382
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 874 [1]
    Number of subjects completed
    		 559

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screen failures: 311
    Reason: Number of subjects
    		 Not randomised and not screen failed: 4
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Pre-assignment is the screening period, and the number screened is not expected to equal the number enrolled/randomised.
    Period 1
    Period 1 title
    Randomisation
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BGF MDI HFO 320/14.4/9.6 μg
    Arm description
    		 Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Budesonide/ Glycopyrronium/ Formoterol fumarate pressurized inhalation suspension, HFO
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    160/7.2/4.8 μg per actuation. 2 inhalations BID.

    Arm title
    		 BGF MDI HFA 320/14.4/9.6 μg
    Arm description
    		 Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Budesonide/ Glycopyrronium/ Formoterol fumarate pressurized inhalation suspension, HFA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    160/7.2/4.8 μg per actuation. 2 inhalations BID.

    Number of subjects in period 1
    		BGF MDI HFO 320/14.4/9.6 μg BGF MDI HFA 320/14.4/9.6 μg
    Started
    280
    279
    Completed
    280
    279
    Period 2
    Period 2 title
    12-week treatment period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BGF MDI HFO 320/14.4/9.6 μg
    Arm description
    		 Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Budesonide/ Glycopyrronium/ Formoterol fumarate pressurized inhalation suspension, HFO
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    160/7.2/4.8 μg per actuation. 2 inhalations BID.

    Arm title
    		 BGF MDI HFA 320/14.4/9.6 μg
    Arm description
    		 Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Budesonide/ Glycopyrronium/ Formoterol fumarate pressurized inhalation suspension, HFA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    160/7.2/4.8 μg per actuation. 2 inhalations BID.

    Number of subjects in period 2
    		BGF MDI HFO 320/14.4/9.6 μg BGF MDI HFA 320/14.4/9.6 μg
    Started
    280
    279
    Started treatment
    280
    278
    Completed
    235
    257
    Not completed
    45
    22
         Consent withdrawn by subject
    8
    5
         Physician decision
    1
    2
         Adverse event, non-fatal
    20
    9
         Protocol-specified withdrawal criterion met
    1
    -
         Lost to follow-up
    2
    -
         Randomised, not treated
    -
    1
         Discontinued intervention - other reason
    10
    4
         Protocol deviation
    3
    1
    Period 3
    Period 3 title
    52-week treatment period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BGF MDI HFO 320/14.4/9.6 μg
    Arm description
    		 Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Budesonide/ Glycopyrronium/ Formoterol fumarate pressurized inhalation suspension, HFO
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    160/7.2/4.8 μg per actuation. 2 inhalations BID.

    Arm title
    		 BGF MDI HFA 320/14.4/9.6 μg
    Arm description
    		 Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Budesonide/ Glycopyrronium/ Formoterol fumarate pressurized inhalation suspension, HFA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    160/7.2/4.8 μg per actuation. 2 inhalations BID.

    Number of subjects in period 3 [2]
    		BGF MDI HFO 320/14.4/9.6 μg BGF MDI HFA 320/14.4/9.6 μg
    Started
    120
    120
    Assigned 52 weeks and started treatment
    120
    120
    Completed
    86
    94
    Not completed
    34
    26
         Adverse event, serious fatal
    1
    1
         Consent withdrawn by subject
    9
    5
         Physician decision
    2
    2
         Adverse event, non-fatal
    11
    8
         Lost to follow-up
    1
    1
         Discontinued intervention - other reason
    9
    8
         Protocol deviation
    1
    1
    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: All participants randomised were enrolled in the 12-week study. Of these, 120 participants in each arm were assigned (on first-in-study basis) to continue in the extended 52-week study. This is why the number who started the 52-week treatment period is less than the number who completed the 12-week period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BGF MDI HFO 320/14.4/9.6 μg
    Reporting group description
    		 Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze)

    Reporting group title
    BGF MDI HFA 320/14.4/9.6 μg
    Reporting group description
    		 Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA

    Reporting group values
    		 BGF MDI HFO 320/14.4/9.6 μg BGF MDI HFA 320/14.4/9.6 μg Total
    Number of subjects
    		 280 279 559
    Age Categorical
    Units: participants
        <=18 years
    		 0 0 0
        Between 18 and 65 years
    		 86 91 177
        >=65 years
    		 194 188 382
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 67.1 ( 7.7 ) 67.0 ( 7.0 ) -
    Sex: Female, Male
    Units:
        Female
    		 112 131 243
        Male
    		 168 148 316
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 2 2
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 7 4 11
        White
    		 273 272 545
        More than one race
    		 0 1 1
        Unknown or Not Reported
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 43 50 93
        Not Hispanic or Latino
    		 237 228 465
        Unknown or Not Reported
    		 0 1 1
    Age Continuous
    Units: years
        median (full range (min-max))
    		 68.5 (41 to 80) 68.0 (45 to 80) -

    End points

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    End points reporting groups
    Reporting group title
    BGF MDI HFO 320/14.4/9.6 μg
    Reporting group description
    		 Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze)

    Reporting group title
    BGF MDI HFA 320/14.4/9.6 μg
    Reporting group description
    		 Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA
    Reporting group title
    BGF MDI HFO 320/14.4/9.6 μg
    Reporting group description
    		 Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze)

    Reporting group title
    BGF MDI HFA 320/14.4/9.6 μg
    Reporting group description
    		 Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA
    Reporting group title
    BGF MDI HFO 320/14.4/9.6 μg
    Reporting group description
    		 Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze)

    Reporting group title
    BGF MDI HFA 320/14.4/9.6 μg
    Reporting group description
    		 Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA

    Primary: Number and percentage of participants with serious adverse events during the 12-week treatment period

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    End point title
    		 Number and percentage of participants with serious adverse events during the 12-week treatment period [1]
    End point description
    To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
    End point type
    Primary
    End point timeframe
    Over 12 weeks
    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: It is a safety study, and no hypothesis testing was pre-specified
    End point values
    		 BGF MDI HFO 320/14.4/9.6 μg BGF MDI HFA 320/14.4/9.6 μg
    Number of subjects analysed
    280
    278
    Units: Participants
        Any serious adverse event
    15
    12
        No serious adverse events
    265
    266
    No statistical analyses for this end point

    Primary: Number and percentage of participants with serious adverse events during the 52-week treatment period

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    End point title
    		 Number and percentage of participants with serious adverse events during the 52-week treatment period [2]
    End point description
    To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
    End point type
    Primary
    End point timeframe
    Over 52 weeks
    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: It is a safety study, and no hypothesis testing was pre-specified
    End point values
    		 BGF MDI HFO 320/14.4/9.6 μg BGF MDI HFA 320/14.4/9.6 μg
    Number of subjects analysed
    120
    120
    Units: Participants
        Any serious adverse event
    17
    16
        No serious adverse events
    103
    104
    No statistical analyses for this end point

    Primary: Number and percentage of participants with non-serious adverse events >5% during the 12-week treatment period

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    End point title
    		 Number and percentage of participants with non-serious adverse events >5% during the 12-week treatment period [3]
    End point description
    To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
    End point type
    Primary
    End point timeframe
    Over 12 weeks
    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: It is a safety study, and no hypothesis testing was pre-specified
    End point values
    		 BGF MDI HFO 320/14.4/9.6 μg BGF MDI HFA 320/14.4/9.6 μg
    Number of subjects analysed
    280
    278
    Units: Participants
        Any non-serious adverse event at greater than 5%
    46
    47
        No non-serious adverse events at greater than 5%
    234
    231
    No statistical analyses for this end point

    Primary: Number and percentage of participants with non-serious adverse events >5% during the 52-week treatment period

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    End point title
    		 Number and percentage of participants with non-serious adverse events >5% during the 52-week treatment period [4]
    End point description
    To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
    End point type
    Primary
    End point timeframe
    Over 52 weeks
    Notes
    [4] - 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: It is a safety study, and no hypothesis testing was pre-specified
    End point values
    		 BGF MDI HFO 320/14.4/9.6 μg BGF MDI HFA 320/14.4/9.6 μg
    Number of subjects analysed
    120
    120
    Units: Participants
        Any non-serious adverse event at greater than 5%
    46
    67
        No non-serious adverse events at greater than 5%
    74
    53
    No statistical analyses for this end point

    Primary: Number and percentage of participants with adverse events of special interest during the 12-week treatment period

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    End point title
    		 Number and percentage of participants with adverse events of special interest during the 12-week treatment period [5]
    End point description
    To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD. Adverse events of special interest in this study are respiratory events such as dysphonia, cough, dyspnea, wheezing, paradoxical bronchospasm, bronchospasm, and COPD exacerbations.
    End point type
    Primary
    End point timeframe
    Over 12 weeks
    Notes
    [5] - 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: It is a safety study, and no hypothesis testing was pre-specified
    End point values
    		 BGF MDI HFO 320/14.4/9.6 μg BGF MDI HFA 320/14.4/9.6 μg
    Number of subjects analysed
    280
    278
    Units: Participants
        Any adverse event of special interest
    52
    55
        No adverse events of special interest
    228
    223
    No statistical analyses for this end point

    Primary: Number and percentage of participants with adverse events of special interest during the 52-week treatment period

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    End point title
    		 Number and percentage of participants with adverse events of special interest during the 52-week treatment period [6]
    End point description
    To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD. Adverse events of special interest in this study are respiratory events such as dysphonia, cough, dyspnea, wheezing, paradoxical bronchospasm, bronchospasm, and COPD exacerbations.
    End point type
    Primary
    End point timeframe
    Over 52 weeks
    Notes
    [6] - 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: It is a safety study, and no hypothesis testing was pre-specified
    End point values
    		 BGF MDI HFO 320/14.4/9.6 μg BGF MDI HFA 320/14.4/9.6 μg
    Number of subjects analysed
    120
    120
    Units: Participants
        Any adverse event of special interest
    40
    47
        No adverse events of special interest
    80
    73
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    52 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    BGF MDI HFA 320/14.4/9.6 μg
    Reporting group description
    		 Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA

    Reporting group title
    BGF MDI HFO 320/14.4/9.6 μg
    Reporting group description
    		 Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze)

    Serious adverse events
    		 BGF MDI HFA 320/14.4/9.6 μg BGF MDI HFO 320/14.4/9.6 μg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    24 / 278 (8.63%)
    25 / 280 (8.93%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    1
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tongue neoplasm malignant stage unspecified
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 280 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 280 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 280 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 280 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 280 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 280 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 280 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    9 / 278 (3.24%)
    6 / 280 (2.14%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 280 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 280 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Traumatic haemothorax
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 280 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 278 (0.36%)
    1 / 280 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 280 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    2 / 278 (0.72%)
    0 / 280 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 278 (0.36%)
    2 / 280 (0.71%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 280 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 280 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 280 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 278 (0.00%)
    2 / 280 (0.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 280 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Trigeminal palsy
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 280 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 280 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 280 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ear and labyrinth disorders
    Vertigo positional
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 280 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 280 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric varices
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 280 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 280 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 280 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 280 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fibromyalgia
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 280 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral lateral recess stenosis
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 280 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 278 (0.00%)
    2 / 280 (0.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 280 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia haemophilus
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 280 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 278 (0.36%)
    2 / 280 (0.71%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 280 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 280 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 280 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia streptococcal
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 280 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 280 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    0 / 278 (0.00%)
    1 / 280 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 278 (0.36%)
    0 / 280 (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 HFA 320/14.4/9.6 μg BGF MDI HFO 320/14.4/9.6 μg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    80 / 278 (28.78%)
    64 / 280 (22.86%)
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    60 / 278 (21.58%)
    52 / 280 (18.57%)
         occurrences all number
    75
    68
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    30 / 278 (10.79%)
    20 / 280 (7.14%)
         occurrences all number
    39
    24

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Dec 2023
    The CSP was amended primarily to comply with EU CTR requirements for drug abuse and misuse handling, SAE reporting, data archiving and breach reporting, and study results submissions to trial registries. The CSP was also revised to remove the planned clinical data lock after 12 weeks of treatment. The study will now be unblinded only once at the end of the study (after the last subject completes the 52-week treatment period). Both the 12-week analysis and the 52-week analysis will be completed after unblinding occurs at the end of the 52-week treatment period.

    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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