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CompletedNCT05492877CRESCENDOUpdated Aug 29, 2025Results posted

An Efficacy and Safety Study of Mitiperstat (AZD4831) (MPO Inhibitor) vs Placebo in the Treatment of Moderate to Severe COPD.

A Phase 2 interventional study of Mitiperstat (AZD4831) and Placebo in Chronic Obstructive Pulmonary Disease (COPD), sponsored by AstraZeneca. Completed at 101 sites in 14 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-29.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
381
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

This is a research study to evaluate the efficacy and safety of the investigational drug Mitiperstat (AZD4831) in adult patients with chronic obstructive pulmonary disease.

Read the detailed description

Study D6582C00001 is a phase IIa randomised, double blind, placebo controlled, parallel arm study to evaluate the efficacy and safety of Mitiperstat (AZD4831) in adult participants with moderate to severe chronic obstructive pulmonary disease.

Approximately 100 sites globally will participate in this study. Approximately 406 participants will be randomised to two treatment groups; Mitiperstat (AZD4831) vs placebo in a 1:1 ratio.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease (COPD)

Keywords

  • Mitiperstat
  • AZD4831
  • Myeloperoxidase
  • MPO
  • Myeloperoxidase inhibitor
  • COPD
  • Chronic Obstructive Pulmonary Disease
  • Lung function
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's enrollment of 381 is above the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Provision of informed consent.
  • Participants must be deemed as high risk of exacerbations as defined by: >= 1 moderate or severe exacerbation in the previous 24 months; or frequent productive cough; or post-bronchodilator (BD) forced expiratory volume in the first second (FEV1) \< 50% predicted.
  • Participants must be 40-80 years of age inclusive, at the time of signing informed consent form (ICF).
  • Participants who have a confirmed primary diagnosis of moderate to severe COPD.
  • Participants who are current or ex-smokers with a tobacco history of ≥ 10 pack-years.

  • Participants who have a documented stable regimen of triple therapy or dual therapy for

    ≥ 3 months prior to enrolment.

  • Body mass index within the range 18 to 40 kg/m2 (inclusive).

Exclusion criteria

Exclusion Criteria:

  • As judged by the investigator, any evidence of any active medical or psychiatric condition or other reason (at SV1 [screening] and SV3 [pre-dose]) which in the investigator's opinion makes it undesirable for the participant to participate in the study.
  • Current diagnosis of asthma or past diagnosis of asthma which persisted beyond the age of 25 years.
  • Clinically important pulmonary disease other than COPD.
  • Any other clinically relevant abnormal findings on physical examination, laboratory testing including haematology, coagulation, serum chemistry, or urinalysis; or chest CT scan at screening or randomisation, which in the opinion of the investigator or medical monitor may compromise the safety of the participant in the study or interfere with evaluation of the study intervention or reduce the participant's ability to participate in the study.
  • History of a clinically significant infection (viral, bacterial, or fungal; defined as requiring systemic antibiotics, antiviral, or antifungal medication for > 7 days) within 4 weeks prior to SV3 (Day 1) (including unexplained diarrhoea) or clinical suspicion of infection at time of dosing.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
381 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Approximately 203 participants will be randomised to receive placebo.

    Other: Placebo

  • Experimental
    Mitiperstat (AZD4831)

    Approximately 203 participants will be randomised to receive mitiperstat (AZD4831).

    Drug: Mitiperstat (AZD4831)

Interventions

  • DrugMitiperstat (AZD4831)

    Oral dosage, once daily.

  • OtherPlacebo

    Oral dosage, once daily.

06

What researchers measure

Primary outcomes

  1. 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.

    COPDCompEx is a composite endpoint of exacerbations and events defined from participant e-Diaries and peak expiratory flow (PEF). COPDCompEx defined exacerbations included episodes leading to 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.

    Time frame: From baseline to up to 24 weeks

Secondary outcomes

  1. To Assess the PK of Mitiperstat (AZD4831) in Patients With Moderate to Severe COPD

    Measurement of Time to Reach Maximum Plasma Concentration (Tmax) at pre-randomisation (baseline visit) and week 12.

    Time frame: At week 12

  2. To Assess the Pharmacokinetics (PK) of Mitiperstat (AZD4831) in Patients With Moderate to Severe COPD.

    Measurement of Maximum Plasma Concentration (Cmax) at pre-randomisation (baseline visit) and week 12.

    Time frame: At week 12

  3. To Evaluate the Effect of Mitiperstat (AZD4831) as Compared to Placebo on the Time to First Moderate or Severe Exacerbation.

    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.

    Time frame: From baseline to up to week 24

  4. 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.

    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.

    Time frame: From baseline to week 12

  5. To Assess the Effect of Mitiperstat (AZD4831) Compared to Placebo on Respiratory Symptoms in Patients With Moderate to Severe COPD.

    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.

    Time frame: From baseline to week 12 and week 24

  6. To Assess the Effect of Mitiperstat (AZD4831) Compared to Placebo on Respiratory Symptoms in Patients With Moderate to Severe COPD.

    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.

    Time frame: From baseline to week 12 and week 24

  7. To Assess the Effect of Mitiperstat (AZD4831) Compared to Placebo in Disease Impact in Patients With Moderate to Severe COPD.

    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.

    Time frame: From baseline to week 12 and week 24

  8. Change From Baseline to Week 12 in Total COPD Assessment Test (CAT)

    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.

    Time frame: From baseline to Week 12

07

Results

Posted Aug 29, 2025

Participant flow

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).

Participant flow — Overall Study
MilestoneMitiperstatPlacebo
Started189192
Treated189192
Completed165170
Not completed2422
Withdrew: Adverse event117
Withdrew: Death10
Withdrew: Lost to follow-up11
Withdrew: Physician decision12
Withdrew: Protocol violation11
Withdrew: Withdrawal by subject37
Withdrew: Reason not specified64

Outcome measures

PrimaryTo 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.

COPDCompEx is a composite endpoint of exacerbations and events defined from participant e-Diaries and peak expiratory flow (PEF). COPDCompEx defined exacerbations included episodes leading to 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.

Time frame:
From baseline to up to 24 weeks
Reported as:
Count of participants · Participants
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.
ParticipantsMitiperstatPlacebo
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.125125
Statistical analysis
  • Mitiperstat vs Placebo · Regression, Cox · p = 0.599 · Hazard ratio (hr): 1.071 · 90% CI 0.869 to 1.320
SecondaryTo Assess the PK of Mitiperstat (AZD4831) in Patients With Moderate to Severe COPD

Measurement of Time to Reach Maximum Plasma Concentration (Tmax) at pre-randomisation (baseline visit) and week 12.

Time frame:
At week 12
Reported as:
Median · hours
To Assess the PK of Mitiperstat (AZD4831) in Patients With Moderate to Severe COPD
hoursMitiperstat
To Assess the PK of Mitiperstat (AZD4831) in Patients With Moderate to Severe COPD1.292 (0.42 to 2.92)
SecondaryTo Assess the Pharmacokinetics (PK) of Mitiperstat (AZD4831) in Patients With Moderate to Severe COPD.

Measurement of Maximum Plasma Concentration (Cmax) at pre-randomisation (baseline visit) and week 12.

Time frame:
At week 12
Reported as:
Geometric mean · nmol/L
To Assess the Pharmacokinetics (PK) of Mitiperstat (AZD4831) in Patients With Moderate to Severe COPD.
nmol/LMitiperstat
To Assess the Pharmacokinetics (PK) of Mitiperstat (AZD4831) in Patients With Moderate to Severe COPD.38.786 ± 39.5
SecondaryTo Evaluate the Effect of Mitiperstat (AZD4831) as Compared to Placebo on the Time to First Moderate or Severe Exacerbation.

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.

Time frame:
From baseline to up to week 24
Reported as:
Count of participants · Participants
To Evaluate the Effect of Mitiperstat (AZD4831) as Compared to Placebo on the Time to First Moderate or Severe Exacerbation.
ParticipantsMitiperstatPlacebo
To Evaluate the Effect of Mitiperstat (AZD4831) as Compared to Placebo on the Time to First Moderate or Severe Exacerbation.5344
Statistical analysis
  • Mitiperstat vs Placebo · Regression, Cox · Hazard ratio (hr): 1.234 · 90% CI 0.882 to 1.726
SecondaryTo 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.

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.

Time frame:
From baseline to week 12
Reported as:
Least squares mean · Litre
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.
LitreMitiperstatPlacebo
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.-0.049 ± 0.0178-0.031 ± 0.0175
SecondaryTo Assess the Effect of Mitiperstat (AZD4831) Compared to Placebo on Respiratory Symptoms in Patients With Moderate to Severe COPD.

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.

Time frame:
From baseline to week 12 and week 24
Reported as:
Least squares mean · Units on a scale
To Assess the Effect of Mitiperstat (AZD4831) Compared to Placebo on Respiratory Symptoms in Patients With Moderate to Severe COPD.
Units on a scaleMitiperstatPlacebo
Week 120.1 ± 0.97-2.4 ± 0.95
Week 24-1.9 ± 1.32-3.7 ± 1.36
SecondaryTo Assess the Effect of Mitiperstat (AZD4831) Compared to Placebo on Respiratory Symptoms in Patients With Moderate to Severe COPD.

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.

Time frame:
From baseline to week 12 and week 24
Reported as:
Least squares mean · Units on a scale
To Assess the Effect of Mitiperstat (AZD4831) Compared to Placebo on Respiratory Symptoms in Patients With Moderate to Severe COPD.
Units on a scaleMitiperstatPlacebo
Week 120.16 ± 0.1300.15 ± 0.127
Week 240.11 ± 0.166-0.17 ± 0.172
SecondaryTo Assess the Effect of Mitiperstat (AZD4831) Compared to Placebo in Disease Impact in Patients With Moderate to Severe COPD.

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.

Time frame:
From baseline to week 12 and week 24
Reported as:
Least squares mean · Units on a scale
To Assess the Effect of Mitiperstat (AZD4831) Compared to Placebo in Disease Impact in Patients With Moderate to Severe COPD.
Units on a scaleMitiperstatPlacebo
Week 12-1.25 ± 1.183-3.05 ± 1.160
Week 24-2.64 ± 1.540-3.48 ± 1.562
SecondaryChange From Baseline to Week 12 in Total COPD Assessment Test (CAT)

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.

Time frame:
From baseline to Week 12
Reported as:
Least squares mean · Units on a scale
Change From Baseline to Week 12 in Total COPD Assessment Test (CAT)
Units on a scaleMitiperstatPlacebo
Change From Baseline to Week 12 in Total COPD Assessment Test (CAT)-1.2 ± 0.62-1.2 ± 0.64

Adverse events

Collected over From Day 1 to Week 24. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Mitiperstat1/189 (0.5%)23/189 (12.2%)53/189 (28%)
Placebo0/192 (0%)13/192 (6.8%)45/192 (23.4%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventMitiperstatPlacebo
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders14/1895/192
PneumoniaInfections and infestations5/1893/192
Pulmonary embolismRespiratory, thoracic and mediastinal disorders0/1892/192
Squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1891/192
Carotid artery thrombosisNervous system disorders1/1890/192
Respiratory failureRespiratory, thoracic and mediastinal disorders1/1890/192
Aortic aneurysmVascular disorders1/1890/192
Atrial fibrillationCardiac disorders1/1890/192
Cardiac failure acuteCardiac disorders1/1890/192
ConstipationGastrointestinal disorders1/1890/192
Most frequent other events
Most frequent other events
EventMitiperstatPlacebo
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders45/18936/192
NasopharyngitisInfections and infestations11/18912/192

Baseline characteristics

Age, Continuous
Age, Continuous(Years)MitiperstatPlaceboTotal
Mean66.2 ± 6.6565.7 ± 7.0366 ± 6.84
Sex: Female, Male
Sex: Female, Male(Participants)MitiperstatPlaceboTotal
Female7774151
Male112118230
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)MitiperstatPlaceboTotal
Hispanic or Latino262753
Not Hispanic or Latino163165328
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)MitiperstatPlaceboTotal
American Indian or Alaska Native112
Asian112
Native Hawaiian or Other Pacific Islander000
Black or African American213
White182183365
More than one race000
Unknown or Not Reported369
08

Study locations

101 sites
  • Research Site
    Newport Beach, California 92663, United States
  • Research Site
    Clearwater, Florida 33765, United States
  • Research Site
    DeLand, Florida 32720, United States
  • Research Site
    Miami, Florida 33186, United States
  • Research Site
    Orlando, Florida 32825, United States
  • Research Site
    Tampa, Florida 33606, United States
  • Research Site
    Winter Park, Florida 32789, United States
  • Research Site
    Chicago Ridge, Illinois 60415, United States
  • Research Site
    Ann Arbor, Michigan 48109, United States
  • Research Site
    Chesterfield, Missouri 63017, United States
  • Research Site
    Saint Charles, Missouri 63301, United States
  • Research Site
    New Windsor, New York 12553, United States
  • Research Site
    Gastonia, North Carolina 28054, United States
  • Research Site
    Kernersville, North Carolina 27284, United States
  • Research Site
    New Bern, North Carolina 28562, United States
  • Research Site
    Columbus, Ohio 43215, United States
  • Research Site
    Choctaw, Oklahoma 73020, United States
  • Research Site
    Fort Mill, South Carolina 29707, United States
  • Research Site
    Amarillo, Texas 79106, United States
  • Research Site
    Buenos Aires, C1121ABE, Argentina
  • Research Site
    Buenos Aires, C1414AIF, Argentina
  • Research Site
    Buenos Aires, C1425BEN, Argentina
  • Research Site
    Córdoba, X5003DCE, Argentina
  • Research Site
    Ranelagh, 1886, Argentina
  • Research Site
    San Fernando, B1646EBJ, Argentina
  • Research Site
    Dupnitsa, 2602, Bulgaria
  • Research Site
    Haskovo, 6305, Bulgaria
  • Research Site
    Pernik, 2300, Bulgaria
  • Research Site
    Rousse, 7000, Bulgaria
  • Research Site
    Sofia, 1756, Bulgaria
  • Research Site
    Stara Zagora, 6000, Bulgaria
  • Research Site
    Stara Zagora, 6003, Bulgaria
  • Research Site
    Vratsa, 3000, Bulgaria
  • Research Site
    Calgary, Alberta T3B 0M3, Canada
  • Research Site
    Québec, Quebec G1V 4G5, Canada
  • Research Site
    Québec, Quebec G3K 2P8, Canada
  • Research Site
    Saint-Charles-Borromée, Quebec J6E 2B4, Canada
  • Research Site
    Trois-Rivières, Quebec G8T 7A1, Canada
  • Research Site
    Aalborg, 9000, Denmark
  • Research Site
    Hvidovre, 2650, Denmark
  • Research Site
    København NV, 2400, Denmark
  • Research Site
    Næstved, 4700, Denmark
  • Research Site
    Odense C, 5000, Denmark
  • Research Site
    Vejle, 7100, Denmark
  • Research Site
    Berlin, 10119, Germany
  • Research Site
    Frankfurt, 60596, Germany
  • Research Site
    Immenhausen, 34376, Germany
  • Research Site
    Koblenz, 56068, Germany
  • Research Site
    Landsberg, 86899, Germany
  • Research Site
    Leipzig, 04299, Germany
  • Research Site
    Marburg, 35037, Germany
  • Research Site
    Witten, 58452, Germany
  • Research Site
    Foggia, 71100, Italy
  • Research Site
    Roma, 00168, Italy
  • Research Site
    Sassari, 07100, Italy
  • Research Site
    Siena, 53100, Italy
  • Research Site
    Verona, 37134, Italy
  • Research Site
    Culiacán, 80200, Mexico
  • Research Site
    Guadalajara, 44670, Mexico
  • Research Site
    Monterrey, 64310, Mexico
  • Research Site
    Monterrey, 64465, Mexico
  • Research Site
    Veracruz, 91910, Mexico
  • Research Site
    Zapopan, 45138, Mexico
  • Research Site
    Groningen, 9713 GH, Netherlands
  • Research Site
    Veldhoven, 5504 DB, Netherlands
  • Research Site
    Bielsko-Biala, 43-300, Poland
  • Research Site
    Chęciny, 26-060, Poland
  • Research Site
    Karczew, 05-480, Poland
  • Research Site
    Krakow, 31-011, Poland
  • Research Site
    Ksawerów, 95-054, Poland
  • Research Site
    Staszów, 28-200, Poland
  • Research Site
    Szczecin, 70-111, Poland
  • Research Site
    Warsaw, 01-456, Poland
  • Research Site
    Cape Town, 7700, South Africa
  • Research Site
    Durban, 4001, South Africa
  • Research Site
    Durban, 4093, South Africa
  • Research Site
    Tygervalley, 7530, South Africa
  • Research Site
    Vereeniging, 1935, South Africa
  • Research Site
    Granada, 18014, Spain
  • Research Site
    Madrid, 28007, Spain
  • Research Site
    Málaga, 29010, Spain
  • Research Site
    Mérida, 06800, Spain
  • Research Site
    Santander, 39008, Spain
  • Research Site
    Adana, 01330, Turkey (Türkiye)
  • Research Site
    Ankara, 06620, Turkey (Türkiye)
  • Research Site
    Istanbul, 34854, Turkey (Türkiye)
  • Research Site
    Istanbul, 34890, Turkey (Türkiye)
  • Research Site
    Izmir, 35360, Turkey (Türkiye)
  • Research Site
    Mersin, 33343, Turkey (Türkiye)
  • Research Site
    Bradford, BD9 6RJ, United Kingdom
  • Research Site
    Cambridge, CB2 0QQ, United Kingdom
  • Research Site
    Cottingham, HU16 5JQ, United Kingdom
  • Research Site
    Dundee, DD1 9SY, United Kingdom
  • Research Site
    Glasgow, G12 0YN, United Kingdom
  • Research Site
    London, EC1M 6BQ, United Kingdom
  • Research Site
    London, NW3 2QG, United Kingdom
  • Research Site
    Manchester, M8 5RB, United Kingdom
  • Research Site
    Nottingham, NG5 1PB, United Kingdom
  • Research Site
    Rotherham, S65 2QL, United Kingdom
  • Research Site
    Wakefield, WF1 4DG, United Kingdom

Showing the first 100 of 101 sites across 14 countries.

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References and documents

Publications

  • Dijk L, Driessen MMG, Gerritsma YH, Bolton C, Da Silva C, Kocks JWH. How do acute worsening events influence daily life and healthcare-seeking behaviour in patients with COPD: an international multicountry qualitative study. BMJ Open. 2026 Jun 11;16(6):e104245. doi: 10.1136/bmjopen-2025-104245. PubMed 42276801 ↗

Study documents

  • Study protocol · Dec 7, 2023
  • Statistical analysis plan · Oct 4, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting information: Study protocol, Sap

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05492877
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Aug 9, 2022
Start date
Nov 14, 2022
Primary completion
Aug 12, 2024
Completion
Aug 12, 2024
Results posted
Aug 29, 2025
Last update
Aug 29, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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