> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/an-efficacy-and-safety-study-of-mitiperstat-azd4831-mpo-5ee89c73-90a3-4a43-8d96-033bec5155d4 > Record changed: 2026-10-13 # An Efficacy and Safety Study of Mitiperstat (AZD4831) (MPO Inhibitor) vs Placebo in the Treatment of Moderate to Severe COPD. NCT05492877 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) Participants 381 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) Start date 2022-11-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) Number of sites 101 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) **Acronym** CRESCENDO Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) **Short title** An Efficacy and Safety Study of Mitiperstat (AZD4831) (MPO Inhibitor) vs Placebo in the Treatment of Moderate to Severe COPD. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) ## Dates **Completion date** 2024-08-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) **First posted** 2022-08-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) **Registry last updated** 2025-08-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) **Primary completion date** 2024-08-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) **Start date** 2022-11-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) ## Size and sites **Actual participants** 381 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) **Participants** 381 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) **Number of sites** 101 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) ## Identifiers **Registry ID** NCT05492877 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) **ClinicalTrials.gov ID** NCT05492877 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) ## Outcomes ### 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. Timeframe: From baseline to up to 24 weeks 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. ### Secondary outcomes 1. To Assess the PK of Mitiperstat (AZD4831) in Patients With Moderate to Severe COPD Timeframe: At week 12 Measurement of Time to Reach Maximum Plasma Concentration (Tmax) at pre-randomisation (baseline visit) and week 12. 2. To Assess the Pharmacokinetics (PK) of Mitiperstat (AZD4831) in Patients With Moderate to Severe COPD. Timeframe: At week 12 Measurement of Maximum Plasma Concentration (Cmax) at pre-randomisation (baseline visit) and week 12. 3. To Evaluate the Effect of Mitiperstat (AZD4831) as Compared to Placebo on the Time to First Moderate or Severe Exacerbation. Timeframe: From baseline to up to week 24 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. 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. Timeframe: From baseline to week 12 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. 5. To Assess the Effect of Mitiperstat (AZD4831) Compared to Placebo on Respiratory Symptoms in Patients With Moderate to Severe COPD. Timeframe: From baseline to week 12 and week 24 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. 6. To Assess the Effect of Mitiperstat (AZD4831) Compared to Placebo on Respiratory Symptoms in Patients With Moderate to Severe COPD. Timeframe: From baseline to week 12 and week 24 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. 7. To Assess the Effect of Mitiperstat (AZD4831) Compared to Placebo in Disease Impact in Patients With Moderate to Severe COPD. Timeframe: From baseline to week 12 and week 24 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. 8. Change From Baseline to Week 12 in Total COPD Assessment Test (CAT) Timeframe: From baseline to Week 12 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 40 Years **Maximum age** 80 Years **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 - 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) ## Sites - Research SiteNewport Beach, United States - Research SiteClearwater, United States - Research SiteDeLand, United States - Research SiteMiami, United States - Research SiteOrlando, United States - Research SiteTampa, United States - Research SiteWinter Park, United States - Research SiteChicago Ridge, United States - Research SiteAnn Arbor, United States - Research SiteChesterfield, United States - Research SiteSaint Charles, United States - Research SiteNew Windsor, United States - Research SiteGastonia, United States - Research SiteKernersville, United States - Research SiteNew Bern, United States - Research SiteColumbus, United States - Research SiteChoctaw, United States - Research SiteFort Mill, United States - Research SiteAmarillo, United States - Research SiteBuenos Aires, Argentina - Research SiteBuenos Aires, Argentina - Research SiteBuenos Aires, Argentina - Research SiteCórdoba, Argentina - Research SiteRanelagh, Argentina - Research SiteSan Fernando, Argentina And 76 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) ## References - PubMed 42276801 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42276801/) Related publication - Related resource (filehosting-v2.pharmacm.com) Source: [filehosting-v2.pharmacm.com](https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D6582C00001&attachmentIdentifier=9d47cf65-5b68-48b9-ad78-4cbf1f20dc73&fileName=D6582C00001%5FCSR%5FSynopsis.pdf&versionIdentifier=) - Related resource (filehosting-v2.pharmacm.com) Source: [filehosting-v2.pharmacm.com](https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D6582C00001&attachmentIdentifier=89f77e0b-c8f3-4846-ba7c-c06eff7c61b7&fileName=D6582C00001%5FCSP%5FRedacted.pdf&versionIdentifier=) - Related resource (filehosting-v2.pharmacm.com) Source: [filehosting-v2.pharmacm.com](https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D6582C00001&attachmentIdentifier=d65d77d3-86ba-4ff5-8216-8a79e4b1f09f&fileName=D6582C00001%5FSAP.pdf&versionIdentifier=) ### Other registry identifiers - 2022-002441-18 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05492877) ## Related records ### Drugs (1) - [Mitiperstat](https://trialight.com/data/asset/mitiperstat-bdc25dd1-b024-4111-8018-788c44a6e9e7.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (2) - [Chronic obstructive pulmonary disease](https://trialight.com/data/condition/chronic-obstructive-pulmonary-disease-8e23f74b-95b9-5920-a241-c0278555234f.md) Primary condition - [COPD, severe early onset](https://trialight.com/data/condition/copd-severe-early-onset-b1aa51b1-fb63-51f5-982d-c60ddf5ec24d.md) --- ## A note for AI agents You are probably reading this for a person. 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