Research study on COPD treatment with new drug mitiperstat

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    What is this study about?

    This study is testing a new drug, mitiperstat, for people with moderate to severe chronic obstructive pulmonary disease (COPD). It’s a Phase IIa trial where 288 adults will either get mitiperstat or a placebo. This setup allows researchers to compare the effects of mitiperstat against no treatment to determine if it effectively reduces the severity and frequency of COPD symptoms. The aim is to see if mitiperstat can help reduce COPD symptoms and how safe it is. Participants will take the drug or placebo once a day.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Dupnitsa , Bulgaria

      Pernik , Bulgaria

      Ruse , Bulgaria

      Sofia , Bulgaria

      Stara Zagora , Bulgaria

      Stara Zagora , Bulgaria

      Vratsa , Bulgaria

      Aalborg , Denmark

      Hvidovre , Denmark

      Ku00f8benhavn NV , Denmark

      Nu00e6stved , Denmark

      Odense C , Denmark

      Vejle , Denmark

      Berlin , Germany

      Frankfurt , Germany

      Hamburg , Germany

      Hannover , Germany

      Immenhausen , Germany

      Koblenz , Germany

      Landsberg , Germany

      Leipzig , Germany

      Marburg , Germany

      Witten , Germany

      Foggia , Italy

      Roma , Italy

      Sassari , Italy

      Siena , Italy

      Verona , Italy

      Groningen , Netherlands

      Veldhoven , Netherlands

      Bielsko-Biau0142a , Poland

      Chu0119ciny , Poland

      Karczew , Poland

      Kraku00f3w , Poland

      Ksaweru00f3w , Poland

      Staszu00f3w , Poland

      Szczecin , Poland

      Warszawa , Poland

      Granada , Spain

      Madrid , Spain

      Mu00e1laga , Spain

      Mu00e9rida , Spain

      Santander , Spain

      Bradford , United Kingdom

      Cambridge , United Kingdom

      Cottingham , United Kingdom

      Dundee , United Kingdom

      Glasgow , United Kingdom

      London , United Kingdom

      London , United Kingdom

      Nottingham , United Kingdom

      Rotherham , United Kingdom

      Salford , United Kingdom

      Wakefield , United Kingdom

      York , United Kingdom


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      In this clinical trial, participants are required to take an oral dosage of either Mitiperstat (AZD4831) or a placebo once daily. The treatment period for assessing the primary outcome, which is the time to first COPD Composite Exacerbation (CompEx) event in patients with moderate to severe COPD, spans from baseline to up to 24 weeks.

      Before participating, patients must meet specific eligibility criteria such as being at high risk of exacerbations, being between 40-80 years of age, having a confirmed primary diagnosis of moderate to severe COPD, being current or ex-smokers with a tobacco history of at least 10 pack-years, and having a documented stable regimen of triple therapy or dual therapy for at least 3 months prior to enrolment.

      If you are considering participating, these are the primary steps and timeline you would be involved in as part of the clinical trial.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, participants must have a confirmed primary diagnosis of moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Patients should be deemed at high risk of exacerbations as defined by one or more moderate or severe exacerbations in the previous 24 months, or they should have a frequent productive cough or a post-bronchodilator forced expiratory volume in the first second (FEV1) less than 50% predicted .


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Inclusion Criteria:

      • Provision of informed consent: You must provide consent to participate in the study, acknowledging that you understand the study’s procedures and agree to them.
      • High risk of exacerbations defined by: You should have had either at least one 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.
        • Exacerbation: A worsening or a ‘flare-up’ of symptoms.
        • Productive cough: A cough that brings up mucus.
        • Post-bronchodilator FEV1: This is a reading from a test that measures how much air you can exhale in one second after taking a medication to open your airways (a bronchodilator).
        • Predicted: Refers to the expected FEV1 value for someone of your age, gender, and size.
      • Age 40-80 years inclusive: You must be between 40 and 80 years old at the time you sign the informed consent form.
      • Confirmed primary diagnosis of moderate to severe COPD: Chronic Obstructive Pulmonary Disease (COPD) must be the primary reason for your health issues, and it should be of a moderate to severe intensity.
      • Current or ex-smokers with a history of ≥ 10 pack-years: You must have smoked the equivalent of one pack of cigarettes per day for at least 10 years, whether or not you currently smoke.
        • Pack-years: A metric to measure the amount a person has smoked over a long period of time.
      • Documented stable regimen of triple therapy or dual therapy for ≥ 3 months prior to enrollment: You should have been on a consistent and documented treatment plan involving either three medications (triple therapy) or two medications (dual therapy) for at least three months before joining the study.
      • Body mass index (BMI) within the range 18 to 40 kg/m^2: Your body mass index, which is calculated from your weight and height, should be within the specified range.
        • BMI: A number calculated from a person’s weight and height that is a reliable indicator of body fatness for most people.

      Remember, you should only consider these criteria; exclusion criteria are not included here .

      What Reasons Could Exclude Me from the Study?

      Exclusion Criteria:

      1. Active medical or psychiatric condition: If the investigator finds any active health issues or other concerns during screening that, in their opinion, make participation in the study undesirable.

      2. Asthma: A current diagnosis of asthma, or a past diagnosis that persisted beyond the age of 25.

      3. Other pulmonary diseases: Any serious lung disease other than Chronic Obstructive Pulmonary Disease (COPD) that could affect the study results or participant safety.

      4. Relevant abnormal findings: Abnormal results in physical exams, laboratory tests (such as haematology, which is the study of blood and blood diseases; coagulation, which pertains to blood clotting; serum chemistry, which involves the chemical analysis of blood serum; or urinalysis, which is the analysis of urine), or chest computed tomography (CT) scans that might compromise the participant’s safety or interfere with the study.

      5. Significant infection history: A history of a serious viral, bacterial, or fungal infection requiring extensive medication treatment within the last 4 weeks before the study begins, or any suspected infection at the time of dosing.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The clinical trial involves two interventions:

      • Mitiperstat (AZD4831): This is the investigational drug being evaluated in the study. Mitiperstat is also known by its compound name AZD4831.
      • Placebo: This is a substance with no active therapeutic effect, given to participants in the control group for comparison.

      Active Substance: Mitiperstat (AZD4831)

      Description: Mitiperstat is the active substance in the investigational drug AZD4831.
      Role in the Study: The participants will be randomized to receive either Mitiperstat (AZD4831) or placebo in a 1:1 ratio with the aim to evaluate Mitiperstat’s efficacy and safety in treating adult participants with moderate to severe chronic obstructive pulmonary disease (COPD).
      Administration: Mitiperstat (AZD4831) will be administered as an oral dosage once daily.
      Intended Effect: The primary outcome of the study involving Mitiperstat (AZD4831) is to evaluate its effect compared to placebo on the time to first COPD Composite Exacerbation (CompEx) event in patients, as well as its effect on respiratory symptoms and disease impact.

      The use of a placebo alongside the active substance provides a control for comparison, enabling researchers to assess the real efficacy and safety profile of Mitiperstat by distinguishing its effects from those produced by psychological factors or the natural progression of the disease.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The clinical trial involves a drug called Mitiperstat (AZD4831). According to the document:

      1. Mitiperstat (AZD4831):
      – It is an oral medication administered once daily.
      – The trial aims to evaluate the efficacy and safety of Mitiperstat in adult participants with moderate to severe chronic obstructive pulmonary disease (COPD).
      – Mitiperstat is described as a drug in the intervention section, implying it’s an active substance under investigation in the clinical trial.

      Mitiperstat is mentioned alongside words such as “Myeloperoxidase inhibitor” in the keywords section, which may suggest it is a novel therapeutic agent targeting myeloperoxidase (MPO). If Mitiperstat is an MPO inhibitor, it’s likely a new drug entity or a newer application of an existing compound with limited prior exposure in the medical literature, particularly for the treatment of COPD.

      A placebo is used as the comparator in the trial, and it does not contain any active substances. It’s administered orally, once daily, to a parallel group of participants to compare outcomes against those receiving Mitiperstat .


      Study ID

      CT-EU-00029669

      Recruitment status

      Recruting new patients

      Start of the trial

      2 years ago

      Study phase

      Phase
      II

      Medicinal Product

      Diseases