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

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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)

ClinicalTrials.gov ID

NCT05492877

Acronym / sponsor ID

CRESCENDO / D6582C00001

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

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

Phase

Phase 2

Study type

Interventional

Recruitment status

Completed

Enrolment

381 participants (actual)

Lead sponsor

AstraZenecaIndustry (pharma, biotech, devices)

Study start

14 Nov 2022 (actual)

Primary completion

12 Aug 2024 (actual)

Study completion

12 Aug 2024 (actual)

First posted

9 Aug 2022 (actual)

Results

Posted 29 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Quadruple blind (participant, care provider, investigator, outcomes assessor)

Number of arms

2

Model description

Participants will be randomised to receive either Mitiperstat (AZD4831) or placebo.

Who may qualify

Ages

40 to 80 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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.

   Time frame: 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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 42661940Kat R, van der Veen W, Gerritsma YH, Leving MT, Dott W, Elizarova O, Hughes R, Jonstrand C, Kristensson C, Nowojewski A, Wheal A, Kocks JWH. Participant Experience, Acceptability and Feasibility of Virtual and Digitally Supported Visits in a Phase IIa COPD Trial. J Patient Exp. 2026 Aug 26;13:23743735261461849. doi: 10.1177/23743735261461849. eCollection 2026.
• Derived from this study: PubMed 42276801Dijk 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.
• D6582C00001 CSR SynopsisLink provided by the sponsor.
• D6582C00001 CSP RedactedLink provided by the sponsor.
• D6582C00001 SAPLink provided by the sponsor.
• Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

101 sites in 14 countries: see every site and its status.