What side effects are associated with this type of intervention?

Common treatments for COPD, such as combination therapies with umeclidinium/vilanterol and tiotropium, are generally well-tolerated but can cause mild to moderate side effects like nausea, diarrhea, and weight loss. Theophylline, although not commonly recommended, can improve lung function but does not significantly reduce exacerbations and may have side effects like gastrointestinal discomfort. Mucolytics like NAC can reduce exacerbations but may cause cough or bronchospasm when nebulized. PDE4 inhibitors like roflumilast are associated with mild to moderate adverse events, primarily nausea, diarrhea, and weight loss. Mitiperstat, a myeloperoxidase inhibitor, is still under investigation, and its safety profile is being evaluated.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Obstructive Pulmonary Disease (COPD), including bronchodilators like long-acting beta agonists (LABAs) and long-acting muscarinic antagonists (LAMAs), as well as inhaled corticosteroids (ICS). Combination therapies, such as umeclidinium/vilanterol and tiotropium/olodaterol, have also been approved to improve lung function and reduce exacerbations. While Mitiperstat (a Myeloperoxidase Inhibitor) is still under investigation, it represents a novel approach compared to the existing bronchodilators and corticosteroids. Other related drugs include antibiotics like azithromycin for preventing exacerbations and various vaccines to prevent respiratory infections in COPD patients.

What other types of research exist?

Promising novel alternatives to Mitiperstat for COPD patients include: 1) CXCR2 Antagonist MK-7123, which showed significant improvement in FEV1 and time-to-first exacerbation, though it has a dose-dependent decrease in neutrophil count. 2) Ensifentrine (RPL554), an inhaled dual PDE3/4 inhibitor with bronchodilator and anti-inflammatory activities. 3) Umeclidinium/Vilanterol (UMEC/VI), a combination therapy that has shown efficacy and safety in multiple studies, including in Asian populations.

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MPO Inhibitor

Mitiperstat for COPD (CRESCENDO Trial)

Verified Trial

Phase 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Current diagnosis of asthma or past diagnosis of asthma which persisted beyond the age of 25 years

Clinically important pulmonary disease other than COPD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to week 12 and week 24

Summary

This trial is testing a new drug called Mitiperstat (AZD4831) to see if it can help adults with moderate to severe COPD by improving their lung function and reducing symptoms.

Who is the study for?

Adults aged 40-80 with moderate to severe COPD, who are current or ex-smokers with a significant smoking history. They must have had at least one exacerbation in the past two years or show other signs of high risk for exacerbations and be on a stable regimen of COPD therapy.

What is being tested?

The trial is testing Mitiperstat (AZD4831), an experimental drug, against a placebo to see if it's effective and safe for treating chronic obstructive pulmonary disease (COPD) in adults.

What are the potential side effects?

While specific side effects of Mitiperstat are not listed, common risks may include reactions at the site of administration, potential respiratory issues due to underlying COPD conditions, and general medication-related side effects like nausea or headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 80 years old.

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I have been diagnosed with moderate to severe COPD.

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I have smoked at least 10 packs of cigarettes a year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have asthma or had it after turning 25.

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I have a significant lung condition that is not COPD.

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I haven't had a serious infection needing long-term medication in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to week 12 and week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to week 12 and week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 12 and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

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

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

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

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Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Mitiperstat (AZD4831)Experimental Treatment1 Intervention

Approximately 144 participants will be randomised to receive mitiperstat (AZD4831).

Group II: PlaceboPlacebo Group1 Intervention

Approximately 144 participants will be randomised to receive placebo.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chronic Obstructive Pulmonary Disease (COPD) include bronchodilators, antibiotics, and emerging therapies such as myeloperoxidase inhibitors. Bronchodilators, including long-acting beta agonists (LABAs) and long-acting muscarinic antagonists (LAMAs), work by relaxing the muscles around the airways, thereby improving airflow and reducing symptoms like breathlessness. Antibiotics are used to treat and prevent infections that can exacerbate COPD symptoms, significantly reducing treatment failure and mortality rates. Emerging therapies, such as myeloperoxidase inhibitors like Mitiperstat, target specific inflammatory pathways involved in COPD pathogenesis. These treatments are crucial as they address different aspects of the disease, from symptom relief to reducing exacerbations and targeting underlying inflammation, thereby improving the overall quality of life for COPD patients.

Advances in the management of chronic obstructive pulmonary disease.[Treatment of chronic obstructive pulmonary disease].