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Study on Reducing Asthma Medication with Tezepelumab in Patients Aged 12 to 80 with Severe Asthma

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying Severe Asthma, a condition where the airways in the lungs become inflamed and narrowed, making it difficult to breathe. The treatment being tested is called Tezepelumab, which is given as an injection using a pre-filled syringe. The purpose of the study is to see if patients with severe asthma can reduce their regular asthma medication while still keeping their asthma under control.

Participants in the study will receive Tezepelumab and will be monitored to see if they can safely lower their daily asthma medication. The study will last for a period of time, during which patients will have regular check-ups to ensure their asthma remains well-managed. Some participants may receive a placebo, which looks like the real medication but does not contain the active ingredient.

The study aims to help understand if Tezepelumab can allow patients to use less of their usual asthma treatments without losing control over their symptoms. This could potentially lead to fewer medications needed for managing severe asthma, improving the quality of life for those affected by this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and screening

    Upon joining the study, you will attend an initial visit where your eligibility will be confirmed. This includes reviewing your medical history and ensuring you meet the study criteria.

    You will be asked to demonstrate proper inhaler technique. If needed, training will be provided to ensure correct usage before the study begins.

    Your current asthma control will be assessed using a questionnaire. This will help determine your starting point for the study.

  2. Step 2

    Beginning of treatment

    At the start of the study, you will begin receiving the medication tezepelumab. This is administered as a subcutaneous injection, which means it is injected under the skin.

    The dosage is 210 mg of tezepelumab, given once every four weeks. This will continue throughout the study duration.

  3. Step 3

    Regular follow-up visits

    You will have regular follow-up visits to monitor your asthma control and overall health. These visits will occur at specified intervals throughout the study.

    During these visits, your asthma symptoms will be assessed, and any changes in your condition will be recorded.

  4. Step 4

    Assessment at week 24

    At week 24, your asthma control will be evaluated to determine if you have achieved control or have low biomarkers. This assessment will help decide the next steps in your treatment plan.

  5. Step 5

    Adjustment of background therapy

    If you have demonstrated asthma control by week 24, there may be an opportunity to reduce your background asthma therapy while maintaining control.

    This phase aims to assess the potential for reducing daily asthma medication without losing control over your asthma symptoms.

  6. Step 6

    Final assessment at week 56

    At the end of the study, around week 56, a final assessment will be conducted to evaluate your asthma control and the effectiveness of the treatment.

    The goal is to determine if you have successfully reduced your daily asthma medication while maintaining control over your symptoms.

Who can join the trial?

11 criteria

  • Must have a documented history of severe asthma diagnosed by a doctor within the last 10 years.
  • Must be between 12 and 80 years old at the time of signing the consent form.
  • Must provide signed and dated written informed consent before any study-specific procedures. If under the age of majority, a legally authorized representative must also provide consent.
  • Women of childbearing potential must agree to use effective contraception methods during the study and for 16 weeks after the last dose of the study medication.
  • Must have a history of asthma that requires continuous treatment with high-dose inhaled corticosteroids (ICS) and a long-acting beta-agonist (LABA) for at least 6 months before the study starts.
  • Must have a documented history of at least one asthma exacerbation (worsening of asthma symptoms) requiring oral corticosteroids or hospitalization within the last 12 months.
  • Must demonstrate proper inhaler technique before starting the study medication. Training will be provided if needed.
  • Must not use excessive short-acting beta-agonists (SABA) or other specified asthma medications beyond the allowed limits.
  • Must have a pre-bronchodilator FEV1 (a measure of lung function) greater than 60% predicted and show reversibility of more than 12% within 6 months before or at the time of screening.
  • Must have an Asthma Control Questionnaire (ACQ-5) score of 1.5 or higher but less than 3 before starting the study medication.
  • Must have a documented medical record history for at least 12 months before the first study visit.

Who cannot join the trial?

10 criteria

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who have had a recent severe asthma attack requiring hospitalization.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of non-compliance with medical treatments.
  • Patients who are pregnant or breastfeeding.
  • Patients with a known allergy to the study medication or its ingredients.
  • Patients who have used certain medications that might interfere with the study results.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients with a history of certain lung diseases other than asthma.
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Investigated drugs

Tezepelumab is a medication used in this clinical trial for patients with severe asthma. It works by blocking a specific protein in the body that can cause inflammation in the airways. This helps to reduce asthma symptoms and improve breathing. The goal of using Tezepelumab in this study is to see if patients can lower their other asthma medications while still keeping their asthma under control. The trial aims to find out if patients can maintain good asthma control and possibly achieve clinical remission, which means having very few or no asthma symptoms, by using Tezepelumab.

What is already known about the treatment

Tezepelumab – Tezepelumab is administered as an injection, typically under the skin, and is currently being studied in clinical trials for its effectiveness in treating severe asthma. It is a promising medication in the medical field, with ongoing research to determine its ability to help patients reduce their other asthma medications while maintaining control over their symptoms. Tezepelumab works by blocking a specific protein in the body that is involved in the inflammation process, which is a key factor in asthma attacks. It is classified as a monoclonal antibody, a type of drug designed to target specific molecules in the body.

Investigated diseases

Severe Asthma – Severe asthma is a chronic respiratory condition characterized by frequent and intense episodes of airway narrowing and inflammation. This leads to symptoms such as wheezing, shortness of breath, chest tightness, and coughing. The disease progresses with persistent symptoms despite high-dose inhaled corticosteroids and other long-term control medications. Patients may experience frequent exacerbations, which are sudden worsening of symptoms that can require additional treatment. Over time, severe asthma can lead to a decline in lung function and increased sensitivity to various triggers, such as allergens, exercise, or respiratory infections. The condition requires ongoing management to maintain control and prevent exacerbations.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512113-41-00Protocol codeD5180C00047Estimated enrolment302 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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