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Study of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) to Reduce Disease Flare-ups

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Chronic Obstructive Pulmonary Disease (COPD), a long-term lung condition that causes breathing difficulties. The research examines the effectiveness of a medication called tezepelumab, which is given as an injection under the skin, compared to placebo in adults with moderate to very severe forms of the disease.

The main purpose of this study is to determine if tezepelumab can reduce the number of COPD flare-ups (also called exacerbations) in patients. During the study, participants will receive either tezepelumab or placebo through subcutaneous injection using a pre-filled syringe. The treatment period will last for approximately 76 weeks.

The medication being tested, tezepelumab (also known as MEDI9929), is already approved for other uses and is being studied to understand if it can help people with COPD. Throughout the study, doctors will monitor how well the treatment works and check for any side effects. Participants will need to continue using their regular COPD medications during the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening and qualification

    Your eligibility for the study will be assessed based on specific health criteria

    Medical tests will be performed, including lung function tests to measure your FEV1 (amount of air you can exhale in one second)

    Your medical history of COPD (chronic lung disease) will be reviewed

    Blood tests will check your eosinophil level (type of white blood cell)

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either Tezspire or a placebo (inactive substance)

    Neither you nor your doctor will know which treatment you are receiving

    The medication will be given as an injection under the skin (subcutaneous injection)

  3. Step 3

    Treatment period

    The study will last for 76 weeks (approximately 1.5 years)

    You will receive regular injections of either Tezspire 210 mg or placebo

    Your current inhaled medications for COPD will be continued as prescribed

  4. Step 4

    Monitoring and assessments

    Regular clinic visits to check your lung function

    Completion of questionnaires about your symptoms and quality of life

    Monitoring of any breathing problems or COPD flare-ups

    Blood samples will be collected to measure drug levels and check for antibodies

    Your overall health and any side effects will be monitored throughout the study

  5. Step 5

    Final evaluation

    Final assessment of your lung function and symptoms at week 76

    Review of any breathing problems or COPD flare-ups during the study period

    Final blood tests and health checks

    Completion of final quality of life questionnaires

Who can join the trial?

8 criteria

  • Age between 40 and 80 years old at the time of signing consent
  • Must have been diagnosed with COPD (Chronic Obstructive Pulmonary Disease) by a doctor for at least 12 months before first visit
  • Must have specific lung function test results showing: - A reduced ratio of exhaled air volume (FEV1/FVC ratio less than 0.70) - Lung capacity between 20% and 70% of normal predicted value after using bronchodilator medication
  • Must be using prescribed inhalers regularly for at least 3 consecutive months, either: - Three different types combined (steroid + two types of bronchodilators), or - Two different types combined (any combination of steroid and bronchodilators)
  • History of either: - At least 2 moderate COPD flare-ups, or - At least 1 severe COPD flare-up in the past 12 months At least one moderate flare-up must have been treated with steroids
  • Must have a blood test showing eosinophil count of 150 cells or higher during screening
  • Must score 15 or higher on the COPD Assessment Test (CAT), which measures COPD symptoms
  • Must be either: - Current smoker, or - Former smoker who quit at least 6 months before first visit With history of smoking at least 10 pack-years (equivalent to smoking 20 cigarettes daily for 10 years)

Who cannot join the trial?

13 criteria

  • History of asthma or current diagnosis of asthma (a chronic condition that affects breathing and causes wheezing)
  • Current active lung infection or any other significant lung disease besides COPD
  • Use of immunosuppressive medications (drugs that lower the body's immune response) within 3 months before the study
  • History of cancer within the past 5 years, except for successfully treated skin cancer
  • Serious heart conditions or uncontrolled high blood pressure
  • Liver disease or abnormal liver function tests
  • Kidney disease or significantly reduced kidney function
  • Current smokers or those who quit smoking less than 6 months ago
  • Participation in another clinical trial within the past 30 days
  • Previous treatment with tezepelumab or similar medications
  • History of severe allergic reactions to any medications
  • Pregnant women or women planning to become pregnant during the study
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
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Investigated drugs

Tezepelumab is a medication being studied for treating moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). It is designed to reduce the frequency and severity of COPD exacerbations (flare-ups). This medication works by targeting specific proteins in the body that are involved in airway inflammation, potentially helping patients who experience frequent worsening of their COPD symptoms.

What is already known about the treatment

Tezepelumab - A biologic medication administered through subcutaneous injection that represents a novel approach in treating Chronic Obstructive Pulmonary Disease (COPD). This monoclonal antibody works by targeting thymic stromal lymphopoietin (TSLP), a key protein involved in airway inflammation, making it part of the class of biological disease-modifying drugs. Currently undergoing Phase III clinical trials for moderate to very severe COPD, tezepelumab shows promise in reducing COPD exacerbations and improving lung function by blocking inflammatory pathways that contribute to airway obstruction and inflammation. The medication has already demonstrated effectiveness in severe asthma treatment, with research now expanding to evaluate its potential benefits for COPD patients.

Investigated diseases

Chronic Obstructive Pulmonary Disease (COPD) - A progressive lung condition that makes breathing difficult due to narrowed airways and damaged lung tissue. The disease typically develops over many years, causing the airways to become inflamed and the air sacs in the lungs to lose their natural elasticity. People with COPD experience persistent breathing difficulties, frequent coughing, and increased mucus production. The condition often results in repeated episodes called exacerbations, where symptoms become notably worse for several days. COPD commonly affects long-term smokers and can also develop from long-term exposure to harmful air particles or gases.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517457-27-00Protocol codeJOURNEYEstimated enrolment991 patientsSponsorAstraZeneca AB

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