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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05492877
Recruitment Status : Recruiting
First Posted : August 9, 2022
Last Update Posted : April 5, 2023
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
This is a research study to evaluate the efficacy and safety of the investigational drug AZD4831 in adult participants with chronic obstructive pulmonary disease.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: AZD4831 Other: Placebo Phase 2

Detailed Description:

Study D6582C00001 is a phase IIa randomised, double blind placebo controlled, parallel arm study to evaluate the efficacy and safety of AZD4831 in adult participants with moderate to severe chronic obstructive pulmonary disease.

Approximately 101 sites globally will participate in this study. Approximately 288 participants will be randomised to two treatment groups (AZD4831 vs placebo) in a 1:1 ratio.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomised to receive either AZD4831 or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a Randomised, Double Blind, Placebo Controlled, Parallel Arm, Multi-Centre Study to Evaluate the Efficacy and Safety of AZD4831 in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Actual Study Start Date : November 14, 2022
Estimated Primary Completion Date : May 13, 2024
Estimated Study Completion Date : May 13, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Approximately 144 participants will be randomised to receive placebo.
 Other: Placebo
Oral dosage, once daily.
Experimental: AZD4831
Approximately 144 participants will be randomised to receive AZD4831.
 Drug: AZD4831
Oral dosage, once daily.


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the effect of AZD4831 as compared to placebo on the time to first COPD Composite Exacerbation (CompEx) event. [ Time Frame: From baseline to up to 24 weeks ]
    All participants randomised to either active or placebo arm.


Secondary Outcome Measures :
  1. To assess the pharmacokinetics (PK) of AZD4831 in participants with moderate to severe COPD. [ Time Frame: Baseline and week 12 (or at early discontinuation visit due to rash) ]
    Measurement of Maximum Plasma Concentration (Cmax) at pre-randomisation (baseline visit) and week 12 (or at early discontinuation visit due to rash).

  2. To assess the PK of AZD4831 in participants with moderate to severe COPD [ Time Frame: Baseline and week 12 (or at early discontinuation visit due to rash) ]
    Measurement of Time to Reach Maximum Plasma Concentration (Tmax) at pre-randomisation (baseline visit) and week 12 (or at early discontinuation visit due to rash).

  3. To evaluate the effect of AZD4831 as compared to placebo on the time to first moderate or severe exacerbation. [ Time Frame: From baseline to up to week 24 ]
    All participants randomised to either active or placebo arms.

  4. To assess the effects of AZD4831 as compared to placebo on post-bronchodilator (BD) forced expiratory volume in the first second (FEV1) in participants with moderate to severe COPD. [ Time Frame: From baseline to week 12 ]
    All participants randomised to either active or placebo arms. Change in post-BD FEV1.

  5. To assess the effect of AZD4831 compared to placebo on respiratory symptoms in participants with moderate to severe COPD. [ Time Frame: From baseline to week 12 and week 24 ]
    All participants randomised to either active or placebo arms. 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.

  6. To assess the effect of AZD4831 compared to placebo on respiratory symptoms in participants with moderate to severe COPD. [ Time Frame: From baseline to week 12 and week 24 ]
    All participants randomised to either active or placebo arms. Change from baseline in Breathlessness, Cough and Sputum Score (BCSS) with the 5-point Likert scale ranging from 0 (no symptoms) to 4 (severe symptoms).

  7. To assess the effect of AZD4831 compared to placebo on respiratory symptoms in participants with moderate to severe COPD. [ Time Frame: From baseline to week 12 and week 24 ]
    All participants randomised to either active or placebo arms. Change from baseline in cough Visual Analogue Scale (cough VAS) with the 100-point linear scale ranging from 0 (no cough) to 100 (worst cough).

  8. To assess the effect of AZD4831 compared to placebo in disease impact in participants with moderate to severe COPD. [ Time Frame: From baseline to Week 12 ]
    All participants randomised to either active or placebo arms. Change from baseline in total COPD Assessment Test (CAT) with the 5-point Likert scale ranging from 0 (no symptoms/no impact) to 5 (severe symptoms/impact).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • Participants with a significant Coronavirus Disease 2019 (COVID-19) illness within 6 months of enrolment.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05492877


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Sponsors and Collaborators
AstraZeneca
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05492877    
Other Study ID Numbers: D6582C00001
First Posted: August 9, 2022    Key Record Dates
Last Update Posted: April 5, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
AZD4831
Myeloperoxidase
MPO
Myeloperoxidase inhibitor
 COPD
Chronic Obstructive Pulmonary Disease
Lung function
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
 Chronic Disease
Disease Attributes
Pathologic Processes