381 Participants Needed

Mitiperstat for COPD

(CRESCENDO Trial)

Recruiting at 97 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: AstraZeneca
Must be taking: Triple therapy, Dual therapy
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have a stable regimen of triple or dual therapy for at least 3 months before joining, which suggests you may need to continue your current COPD treatment.

How does the drug AZD4831 differ from other COPD treatments?

The research provided does not contain specific information about AZD4831 or its unique characteristics compared to other COPD treatments.12345

Eligibility Criteria

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.

Inclusion Criteria

Provision of informed consent
I am between 40 and 80 years old.
I have been diagnosed with moderate to severe COPD.
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Exclusion Criteria

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.
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
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Mitiperstat (AZD4831) or placebo for up to 24 weeks

12-24 weeks
Baseline visit, week 12 visit, and week 24 visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • AZD4831
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Mitiperstat (AZD4831)Experimental Treatment1 Intervention
Approximately 203 participants will be randomised to receive mitiperstat (AZD4831).
Group II: PlaceboPlacebo Group1 Intervention
Approximately 203 participants will be randomised to receive placebo.

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

References

A randomised, placebo-controlled, dose-finding study of AZD9668, an oral inhibitor of neutrophil elastase, in patients with chronic obstructive pulmonary disease treated with tiotropium. [2022]
Adherence to the Swiss guidelines for management of COPD: experience of a Swiss teaching hospital. [2022]
Review of guidelines and the literature in the treatment of acute bronchospasm in chronic obstructive pulmonary disease. [2022]
[Survey of chest physicians regarding COPD diagnosis and treatment]. [2015]
[Chronic obstructive respiratory diseases: diagnosis and therapy]. [2009]