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    Clinical Trial Results:
    A Phase IIa Randomised, Double Blind, Placebo Controlled, Parallel Arm, Multi-Centre Study to Evaluate the Efficacy and Safety of Mitiperstat (AZD4831), for 12-24 Weeks, in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

    Summary
    EudraCT number
    		 2022-002441-18
    Trial protocol
    		 DK   ES   NL   IT   BG   DE  
    Global end of trial date
    30 Oct 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Aug 2025
    First version publication date
    14 Aug 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D6582C00001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05492877
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    151 85, Södertälje, Sweden,
    Public contact
    Global Clinical Lead, AstraZeneca Clinical Study Information Center, +1 8772409479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca Clinical Study Information Center, +1 8772409479, 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
    12 May 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Aug 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Oct 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first COPDCompEx event in patients with moderate to severe COPD.
    Protection of trial subjects
    The study was performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with International Council for Harmonisation (ICH)/Good Clinical Practice (GCP), and applicable regulatory requirements. All participant must meet all inclusion criteria and not meet any exclusion criteria before receiving investigational product. IDMC was formed to monitor potential risk in the study
    Background therapy
    		 Participants need to be on stable regimen of triple therapy or dual therapy for ≥ 3 months prior to enrolment (change of inhaler device or change of medication in the same drug class is allowed). Triple therapy may consist of an appropriate combination of ICS + LABA + LAMA. Dual therapy consists of either inhaled ICS + LABA or LABA + LAMA where the treating physician deems the participant unsuitable for ICS (eg, blood eosinophil count ≤ 100 cells/μL on 2 separate occasions, or on the basis of previous or perceived risk of significant AEs from ICS-based therapy, such as previous episodes of pneumonia or significant oral candidiasis).
    Evidence for comparator
    		 Not applicable as there was no comparator arm in the study
    Actual start date of recruitment
    14 Nov 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 24
    Country: Number of subjects enrolled
    United States: 41
    Country: Number of subjects enrolled
    Bulgaria: 28
    Country: Number of subjects enrolled
    Poland: 30
    Country: Number of subjects enrolled
    Türkiye: 20
    Country: Number of subjects enrolled
    Denmark: 34
    Country: Number of subjects enrolled
    Italy: 9
    Country: Number of subjects enrolled
    Netherlands: 7
    Country: Number of subjects enrolled
    Spain: 31
    Country: Number of subjects enrolled
    United Kingdom: 52
    Country: Number of subjects enrolled
    Argentina: 26
    Country: Number of subjects enrolled
    Mexico: 14
    Country: Number of subjects enrolled
    South Africa: 10
    Country: Number of subjects enrolled
    Germany: 55
    Worldwide total number of subjects
    381
    EEA total number of subjects
    194
    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)
    158
    From 65 to 84 years
    223
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 101 centers in 14 countries (Argentina, Bulgaria, Canada, Denmark, Germany, Italy, Mexico, Netherlands, Poland, South Africa, Spain, Turkey, UK and USA).

    Pre-assignment
    Screening details
    		 A total of 381 participants were randomized and received at least one dose of study drug.

    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
    		 Investigator, Monitor, Carer, Data analyst, Assessor, Subject
    Blinding implementation details
    Participant was randomised using an interactive web response system to receive either 5mg mitiperstat or placebo. Participants, investigators and the sponsors are blinded with regard to the actual dose information.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Mitiperstat
    Arm description
    		 Participants received an oral tablet of mitiperstat 5mg once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mitiperstat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg once daily

    Arm title
    		 Placebo
    Arm description
    		 Participants receive an oral tablet of placebo matched to mitiperstat once daily.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily

    Number of subjects in period 1
    		Mitiperstat Placebo
    Started
    189
    192
    Treated
    189
    192
    Completed
    165
    170
    Not completed
    24
    22
         Adverse event, serious fatal
    1
    -
         Physician decision
    1
    2
         Consent withdrawn by subject
    3
    7
         Adverse event, non-fatal
    11
    7
         Lost to follow-up
    1
    1
         Reason not specified
    6
    4
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mitiperstat
    Reporting group description
    		 Participants received an oral tablet of mitiperstat 5mg once daily.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants receive an oral tablet of placebo matched to mitiperstat once daily.

    Reporting group values
    		 Mitiperstat Placebo Total
    Number of subjects
    		 189 192 381
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 75 83 158
        From 65-84 years
    		 114 109 223
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 66.2 ( 6.65 ) 65.7 ( 7.03 ) -
    Sex: Female, Male
    Units:
        Female
    		 77 74 151
        Male
    		 112 118 230
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 26 27 53
        Not Hispanic or Latino
    		 163 165 328
        Unknown or Not Reported
    		 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 1 1 2
        Asian
    		 1 1 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 2 1 3
        White
    		 182 183 365
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 3 6 9

    End points

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    End points reporting groups
    Reporting group title
    Mitiperstat
    Reporting group description
    		 Participants received an oral tablet of mitiperstat 5mg once daily.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants receive an oral tablet of placebo matched to mitiperstat once daily.

    Primary: To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first COPD Composite Exacerbation (CompEx) event in patients with moderate to severe COPD.

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    End point title
    		 To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first COPD Composite Exacerbation (CompEx) event in patients with moderate to severe COPD.
    End point description
    COPDCompEx is a composite endpoint of exacerbations and events defined from participant e-Diaries and peak expiratory flow (PEF). COPDCompEx defined exacerbations as one or more of the following: hospitalization, emergency room visit, treatment with systemic corticosteroids (injected and/or oral), or treatment with antibiotics. Diary COPDCompEx events are defined by threshold and slope criteria being met for >= 2 consecutive days using the following diary and home spirometry variables: overall symptom rating, night-time awakenings due to symptoms, reliever medication use, PEF. COPDCompEx also includes patient withdrawals for treatment failure. The analysis population used was the Full Analysis Set, which included all randomized participants who received at least one dose of study intervention. The 'while on treatment' estimand strategy was followed, meaning that if an intercurrent event occurred, all subsequent data for that subject was excluded from the evaluation
    End point type
    Primary
    End point timeframe
    From baseline to up to 24 weeks
    End point values
    		 Mitiperstat Placebo
    Number of subjects analysed
    189
    192
    Units: Participants
        Count of Participants with a COPDCompEx event
    125
    125
    Statistical analysis title
    		 Cox proportional hazard model
    Comparison groups
    Mitiperstat v Placebo
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.599 [1]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.071
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.869
         upper limit
    		 1.32
    Notes
    [1] - The p-value was based on a 2-sided log rank test stratified by region

    Secondary: To assess the PK of mitiperstat (AZD4831) in patients with moderate to severe COPD

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    End point title
    		 To assess the PK of mitiperstat (AZD4831) in patients with moderate to severe COPD [2]
    End point description
    Measurement of Time to Reach Maximum Plasma Concentration (Tmax) at week 12. The analysis population used was the PK set which included all participants who had received mitiperstat and had evaluable PK data for mitiperstat, with no important protocol deviations that were thought to have impacted the analysis of the PK data.
    End point type
    Secondary
    End point timeframe
    At week 12
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There is no PK data for placebo arm. There is no PK data at baseline
    End point values
    		 Mitiperstat
    Number of subjects analysed
    36
    Units: hours
        median (full range (min-max))
    1.292 (0.42 to 2.92)
    No statistical analyses for this end point

    Secondary: To assess the pharmacokinetics (PK) of mitiperstat (AZD4831) in patients with moderate to severe COPD.

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    End point title
    		 To assess the pharmacokinetics (PK) of mitiperstat (AZD4831) in patients with moderate to severe COPD. [3]
    End point description
    Measurement of Maximum Plasma Concentration (Cmax) at week 12. The analysis population used was the PK set which included all participants who had received mitiperstat and had evaluable PK data for mitiperstat, with no important protocol deviations that were thought to have impacted the analysis of the PK data.
    End point type
    Secondary
    End point timeframe
    At week 12
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There is no PK data for placebo arm. There is no PK data at baseline
    End point values
    		 Mitiperstat
    Number of subjects analysed
    36
    Units: nmol/L
        geometric mean (geometric coefficient of variation)
    38.786 ( 39.5 )
    No statistical analyses for this end point

    Secondary: To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first moderate or severe exacerbation.

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    End point title
    		 To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first moderate or severe exacerbation.
    End point description
    A COPD exacerbation was considered moderate if it required treatment with systemic corticosteroids and/or antibiotics for at least 3 days or resulted in emergency room visit< 24 hours requiring intensive treatment; and did not result in hospitalization or death. A COPD exacerbation was considered severe if it resulted in hospitalization (defined as an inpatient admission ≥ 24 hours in the hospital, an observation area, the emergency department, or other equivalent healthcare facility depending on the country and healthcare system) or death due to COPD. The analysis population used was the Full Analysis Set (FAS), which included all randomized participants who received at least one dose of study intervention. The 'while on treatment' estimand strategy was followed, meaning that if an intercurrent event occurred, all subsequent data for that subject was excluded from the evaluation.
    End point type
    Secondary
    End point timeframe
    From baseline to up to week 24
    End point values
    		 Mitiperstat Placebo
    Number of subjects analysed
    189
    192
    Units: Participants
        Count of participants with an exacerbation event
    53
    44
    Statistical analysis title
    		 Cox proportional hazard model
    Comparison groups
    Mitiperstat v Placebo
    Number of subjects included in analysis
    381
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.234
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.882
         upper limit
    		 1.726

    Secondary: To assess the effects of mitiperstat (AZD4831) as compared to placebo on post-bronchodilator (BD) forced expiratory volume in the first second (FEV1) in patients with moderate to severe COPD.

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    End point title
    		 To assess the effects of mitiperstat (AZD4831) as compared to placebo on post-bronchodilator (BD) forced expiratory volume in the first second (FEV1) in patients with moderate to severe COPD.
    End point description
    The mean change from baseline in Post-BD FEV1 at Week 12 was estimated using a repeated measures mixed effects analysis of covariance. Only subjects with non-missing covariates are included in the analysis. FEV1 was measured by spirometry at clinic. The analysis population used was the Full Analysis Set (FAS), which included all randomized participants who received at least one dose of study intervention. The 'while on treatment' estimand strategy was followed, meaning that if an intercurrent event occurred, all subsequent data for that subject was excluded from the evaluation.
    End point type
    Secondary
    End point timeframe
    From baseline to week 12
    End point values
    		 Mitiperstat Placebo
    Number of subjects analysed
    130
    136
    Units: Litre
        least squares mean (standard error)
    -0.049 ( 0.0178 )
    -0.031 ( 0.0175 )
    No statistical analyses for this end point

    Secondary: To assess the effect of mitiperstat (AZD4831) compared to placebo on respiratory symptoms in patients with moderate to severe COPD - EXACT.

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    End point title
    		 To assess the effect of mitiperstat (AZD4831) compared to placebo on respiratory symptoms in patients with moderate to severe COPD - EXACT.
    End point description
    Change from baseline in EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) which is a 14-item ePRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. It has a theoretical range of 0 to 100, with higher values indicating a more severe condition. The EXACT will be performed at on-site visits using the e-Diary. The analysis population used was the Full Analysis Set (FAS), which included all randomized participants who received at least one dose of study intervention. The 'while on treatment' estimand strategy was followed, meaning that if an intercurrent event occurred, all subsequent data for that subject was excluded from the evaluation.
    End point type
    Secondary
    End point timeframe
    From baseline to week 12 and week 24
    End point values
    		 Mitiperstat Placebo
    Number of subjects analysed
    189
    192
    Units: Units on a scale
    least squares mean (standard error)
        Week 12
    0.1 ( 0.97 )
    -2.4 ( 0.95 )
        Week 24
    -1.9 ( 1.32 )
    -3.7 ( 1.36 )
    No statistical analyses for this end point

    Secondary: To assess the effect of mitiperstat (AZD4831) compared to placebo on respiratory symptoms in patients with moderate to severe COPD - BCSS.

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    End point title
    		 To assess the effect of mitiperstat (AZD4831) compared to placebo on respiratory symptoms in patients with moderate to severe COPD - BCSS.
    End point description
    Change from baseline to Week 12 and week 24 in mean Breathlessness, Cough and Sputum Scale (BCSS) score is reported. The BCSS was a 3-item daily diary that assesses the severity of the 3 symptoms: breathlessness, sputum, and cough, each on a 5-point Likert scale ranging from 0 (no symptoms) to 4 (severe symptoms). Item scores were summed to yield a total score ranging from 0 to 12; wherein higher total score indicated more severe symptoms. The BCSS was captured each evening via eDiary. The analysis population used was the Full Analysis Set (FAS), which included all randomized participants who received at least one dose of study intervention. The 'while on treatment' estimand strategy was followed, meaning that if an intercurrent event occurred, all subsequent data for that subject was excluded from the evaluation.
    End point type
    Secondary
    End point timeframe
    From baseline to week 12 and week 24
    End point values
    		 Mitiperstat Placebo
    Number of subjects analysed
    189
    192
    Units: Units on a scale
    least squares mean (standard error)
        Week 12
    0.16 ( 0.130 )
    0.15 ( 0.127 )
        Week 24
    0.11 ( 0.166 )
    -0.17 ( 0.172 )
    No statistical analyses for this end point

    Secondary: To assess the effect of mitiperstat (AZD4831) compared to placebo in disease impact in patients with moderate to severe COPD.

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    End point title
    		 To assess the effect of mitiperstat (AZD4831) compared to placebo in disease impact in patients with moderate to severe COPD.
    End point description
    Change from baseline to Week 12 and week 24 in cough Visual Analogue Scale (VAS) score is reported. Participants were asked to complete a cough severity VAS (100-point linear scale marked with a horizontal line by the participant, with 0 representing ''no cough'' and 100 representing "worst cough") that measured subjective assessment by the participant of the prior 24 hrs for severity of cough symptoms. It was completed each evening in the eDiary. The analysis population used was the Full Analysis Set (FAS), which included all randomized participants who received at least one dose of study intervention. The 'while on treatment' estimand strategy was followed, meaning that if an intercurrent event occurred, all subsequent data for that subject was excluded from the evaluation.
    End point type
    Secondary
    End point timeframe
    From baseline to week 12 and week 24
    End point values
    		 Mitiperstat Placebo
    Number of subjects analysed
    189
    192
    Units: Units on a scale
    least squares mean (standard error)
        Week 12
    -1.25 ( 1.183 )
    -3.05 ( 1.160 )
        Week 24
    -2.64 ( 1.540 )
    -3.48 ( 1.562 )
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 12 in total COPD Assessment Test (CAT)

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    End point title
    		 Change from baseline to Week 12 in total COPD Assessment Test (CAT)
    End point description
    COPD Assessment Test (CAT) is designed to measure how COPD impacts on a patient’s daily life and how this might change over time. It consists of 8 questions that ask the patient to rate items relating to symptoms and impact on quality of life (such as normal activity and sleep). Each question is performed on a 5-point Likert scale from 0 (no symptoms/no impact) to 5 (severe symptoms/impact). The CAT will be completed by participants at on-site visits using the e-Diary. The analysis population used was the Full Analysis Set (FAS), which included all randomized participants who received at least one dose of study intervention. The 'while on treatment' estimand strategy was followed, meaning that if an intercurrent event occurred, all subsequent data for that subject was excluded from the evaluation.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 12
    End point values
    		 Mitiperstat Placebo
    Number of subjects analysed
    134
    134
    Units: Units on a scale
        least squares mean (standard error)
    -1.2 ( 0.62 )
    -1.2 ( 0.64 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug until the end of the follow-up period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    PLACEBO
    Reporting group description
    		 -

    Reporting group title
    AZD4831
    Reporting group description
    		 -

    Serious adverse events
    		 PLACEBO AZD4831
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 192 (6.77%)
    23 / 189 (12.17%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Carcinoid tumour pulmonary
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 189 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 192 (0.52%)
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Carotid artery thrombosis
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    5 / 192 (2.60%)
    14 / 189 (7.41%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 189 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    2 / 192 (1.04%)
    0 / 189 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 189 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal hypertension
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 189 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    3 / 192 (1.56%)
    5 / 189 (2.65%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 189 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 189 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    		 PLACEBO AZD4831
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 192 (23.44%)
    52 / 189 (27.51%)
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    36 / 192 (18.75%)
    45 / 189 (23.81%)
         occurrences all number
    55
    62
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    12 / 192 (6.25%)
    10 / 189 (5.29%)
         occurrences all number
    14
    10

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jun 2022
    Clinical Study Protocol Version 2. Version 1 of the protocol was not published or used. Version 2 was the first version to be submitted to any Health Authority/Ethics committee
    13 Jan 2023
    Clinical Study Protocol Version 3. Exclusion criterion which excluded participants with a positive diagnostic lateral flow test for SARS-CoV-2 at screening was removed (exclusion criterion 1). Changes were made in response to the requirements of various health authorities. For example, contraceptive requirements.
    28 Apr 2023
    Clinical Study Protocol Version 4. To add the optional substudies which affect only selected sites in selected countries where the substudies will be conducted. A substantial change was made to remove history of treatment with cardiotoxic medications from the list of exclusion criteria (exclusion criterion 22).
    07 Dec 2023
    Clinical Study Protocol Version 5. To increase the sample size, due to changes in statistical assumptions.

    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 significant methodological limitations, protocol deviations or study conduct changes were identified that may have impacted upon the validity or interpretation of the results
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