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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 12 and week 24
Awards & highlights
CRESCENDO Trial Summary
This trial will test a drug to see if it can help adults with COPD feel better and be safe.
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.Check my eligibility
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.See study design
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.
CRESCENDO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
CRESCENDO Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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.
+3 moreCRESCENDO 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.
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Who is running the clinical trial?
AstraZenecaLead Sponsor
4,286 Previous Clinical Trials
288,619,762 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 40 and 80 years old.I have been diagnosed with moderate to severe COPD.I don't have any health issues that could make the study unsafe for me or affect the results.I have a significant lung condition that is not COPD.I have smoked at least 10 packs of cigarettes a year.I have asthma or had it after turning 25.Your body mass index (BMI) is between 18 and 40.I am at high risk of lung issues due to frequent coughs or severe breathing test results.I haven't had a serious infection needing long-term medication in the last 4 weeks.I have been on a stable medication regimen for my condition for at least 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Mitiperstat (AZD4831)
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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