Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002441-18 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Approximately 203 participants will be randomised to receive placebo. |
|
| Mitiperstat (AZD4831) | Experimental | Approximately 203 participants will be randomised to receive mitiperstat (AZD4831). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitiperstat (AZD4831) | Drug | Oral dosage, once daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At week 12 |
| To Assess the Pharmacokinetics (PK) of Mitiperstat (AZD4831) in Patients With Moderate to Severe COPD. |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Newport Beach | California | 92663 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42276801 | Derived | 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. |
| Label | URL |
|---|---|
| D6582C00001 CSR Synopsis | View source |
Not provided
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.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
A total of 381 participants were randomized and received at least one dose of study drug.
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).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mitiperstat | Participants received an oral tablet of mitiperstat 5mg once daily. |
| FG001 | Placebo | Participants receive an oral tablet of placebo matched to mitiperstat once daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 7, 2023 | Jul 17, 2025 |
Not provided
Not provided
Participants will be randomised to receive either Mitiperstat (AZD4831) or placebo.
Not provided
Not provided
Not provided
| Placebo |
| Other |
Oral dosage, once daily. |
|
Measurement of Maximum Plasma Concentration (Cmax) at pre-randomisation (baseline visit) and week 12. |
| At week 12 |
| 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. | From baseline to up to week 24 |
| 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. | From baseline to week 12 |
| 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. | From baseline to week 12 and week 24 |
| 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. | From baseline to week 12 and week 24 |
| 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. | From baseline to week 12 and week 24 |
| 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. | From baseline to Week 12 |
| 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 |
| Research Site | York | YO24 3WX | United Kingdom |
| D6582C00001 CSP Redacted | View source |
| D6582C00001 SAP | View source |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mitiperstat | Participants received an oral tablet of mitiperstat 5mg once daily. |
| BG001 | Placebo | Participants receive an oral tablet of placebo matched to mitiperstat once daily. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Full Analysis Set (FAS) included all randomised participants who received at least one dose of study intervention. 'While on treatment' estimand strategy was followed, which means that if an intercurrent event occurs all subsequent data for that subject was excluded from the evaluation. | Posted | Count of Participants | Participants | From baseline to up to 24 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The PK set 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. | Posted | Median | Full Range | hours | At week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The PK set 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | At week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set (FAS) included all randomised participants who received at least one dose of study intervention. 'While on treatment' estimand strategy was followed, which means that if an intercurrent event occurs all subsequent data for that subject was excluded from the evaluation. | Posted | Count of Participants | Participants | From baseline to up to week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Full Analysis Set (FAS) included all randomised participants who received at least one dose of study intervention. 'While on treatment' estimand strategy was followed, which means that if an intercurrent event occurs all subsequent data for that subject was excluded from the evaluation. | Posted | Least Squares Mean | Standard Error | Litre | From baseline to week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set (FAS) included all randomised participants who received at least one dose of study intervention. 'While on treatment' estimand strategy was followed, which means that if an intercurrent event occurs all subsequent data for that subject was excluded from the evaluation. | Posted | Least Squares Mean | Standard Error | Units on a scale | From baseline to week 12 and week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set (FAS) included all randomised participants who received at least one dose of study intervention. 'While on treatment' estimand strategy was followed, which means that if an intercurrent event occurs all subsequent data for that subject was excluded from the evaluation. | Posted | Least Squares Mean | Standard Error | Units on a scale | From baseline to week 12 and week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set (FAS) included all randomised participants who received at least one dose of study intervention. 'While on treatment' estimand strategy was followed, which means that if an intercurrent event occurs all subsequent data for that subject was excluded from the evaluation. | Posted | Least Squares Mean | Standard Error | Units on a scale | From baseline to week 12 and week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set (FAS) included all randomised participants who received at least one dose of study intervention. 'While on treatment' estimand strategy was followed, which means that if an intercurrent event occurs all subsequent data for that subject was excluded from the evaluation. | Posted | Least Squares Mean | Standard Error | Units on a scale | From baseline to Week 12 |
|
|
From Day 1 to Week 24
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mitiperstat | Participants received an oral tablet of mitiperstat 5mg once daily. | 1 | 189 | 23 | 189 | 53 | 189 |
| EG001 | Placebo | Participants receive an oral tablet of placebo matched to mitiperstat once daily. | 0 | 192 | 13 | 192 | 45 | 192 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tuberculosis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Carcinoid tumour pulmonary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Carotid artery thrombosis | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Portal hypertension | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
AstraZeneca has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca Clinical Study Information Center | +1-877-240-9479 | information.center@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 4, 2024 | Jul 17, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000706810 | AZD4831 |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|