Study on Tezepelumab for Patients with Severe Asthma

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What is this study about?

This clinical trial is focused on studying severe asthma, a condition where the airways in the lungs become inflamed and narrow, making it difficult to breathe. The study will use a treatment called Tezspire, which is a solution for injection containing the active substance tezepelumab. This medication is designed to help reduce inflammation in the airways and improve breathing in people with severe asthma. Some participants will receive a matching placebo, which looks like the medication but does not contain the active substance.

The purpose of the study is to observe changes in the airways of patients with severe asthma over a period of time. Participants will receive either the Tezspire treatment or a placebo for six months. During this time, they will undergo regular CT scans, which are special imaging tests that provide detailed pictures of the airways. These scans will help researchers compare the effects of the treatment on the structure of the airways.

The study will last for up to 12 months, with participants being monitored for changes in their asthma symptoms and overall lung function. The goal is to see if Tezspire can help reverse some of the changes in the airways caused by severe asthma, potentially leading to better breathing and fewer asthma attacks. Participants will have regular check-ups and assessments to track their progress throughout the study.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s objectives and procedures.

The patient will be required to provide informed consent to participate in the trial.

2 initial assessment

The patient will undergo a series of assessments to establish baseline measurements.

These assessments include a computed tomography (CT) scan to measure the bronchial wall area and other lung function tests.

3 treatment phase

The patient will receive either the Tezspire 210 mg solution for injection or a matching placebo.

The medication will be administered as a subcutaneous injection every four weeks for a duration of six months.

4 midpoint evaluation

At the three-month mark, the patient will undergo a follow-up CT scan and lung function tests to monitor changes in the bronchial wall area and other parameters.

5 end of treatment evaluation

After six months of treatment, the patient will have a final CT scan and lung function tests to assess the effects of the treatment.

The primary focus will be on the change in the average percentage bronchial wall area.

6 extended observation

The patient will continue to be monitored for an additional six months to evaluate long-term effects.

This includes periodic CT scans and assessments of lung function and asthma control.

7 completion of study

The study concludes after 12 months, with a final assessment to gather comprehensive data on the treatment’s impact.

The patient will receive a summary of their participation and any relevant findings.

Who Can Join the Study?

You must be at least 18 years old and no older than 85 years old.
If you are taking oral corticosteroids, your daily dose should be no more than 7.5 mg.
Your CT scan should show that the average percentage of the bronchial wall area is more than 65% in certain parts of the lungs.
You need to be able to have a CT scan of your chest and nose while breathing in and out.
Your condition should be stable enough to safely undergo a CT scan.
You must have asthma diagnosed by a doctor following GINA criteria, which are guidelines for asthma care.
Your asthma should have caused at least one severe or two moderate flare-ups in the past year, even with the best treatment available.
You should be on the highest dose of inhaled corticosteroids and at least one other asthma controller medication as per GINA guidelines.
Your lung function test, called FEV1, should show results between 25% and 90% of the expected value after using a bronchodilator, which is a medication that helps open the airways.
Your score on the Asthma Control Questionnaire 6 (ACQ6), which measures asthma control, should be more than 1.5.

Who Cannot Join the Study?

Patients with severe asthma cannot participate. Severe asthma is a type of asthma that is very difficult to control, even with high doses of medication.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Hospital Foch	Suresnes	France
Assistance Publique Hopitaux De Paris	Paris	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Cncmqe Hzorqiqojdt Uxilxqilirned Dh Dastv	Dijon	France
Auvplxbswv Pfxasptk Hdlcueii Dn Mbiijrjsv	Marseille	France
Hjthcpit Ufvflngudybimx Slidxkpdcw &ujalps Hhlosro dt Hzkythctrwr	STRASBOURG, Alsace	France
Cxg Kmjrxia Bbtctup	Le Kremlin-Bicetre	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	27.03.2023

Trial locations

Investigated drugs:

Tezepelumab

Tezepelumab is a medication being studied for its potential to help patients with asthma. It works by targeting specific pathways in the immune system that are involved in inflammation and airway remodeling. The goal of using tezepelumab in this trial is to see if it can reduce the thickening of the walls of the airways, which is a common problem in asthma that can make breathing difficult. This medication is being tested over a period of six months to evaluate its effectiveness in improving the condition of the airways in patients with asthma.

Investigated diseases:

Asthma

Severe Asthma – Severe asthma is a chronic respiratory condition characterized by persistent inflammation and narrowing of the airways, leading to difficulty in breathing. It often involves frequent asthma attacks, which can be triggered by allergens, exercise, or stress. Patients may experience symptoms such as wheezing, coughing, shortness of breath, and chest tightness. Unlike mild or moderate asthma, severe asthma does not respond well to standard treatments and requires more intensive management. Over time, the condition can lead to structural changes in the airways, known as airway remodeling, which can further exacerbate symptoms. Monitoring and managing environmental triggers are crucial in controlling the progression of severe asthma.

Trial ID:

2024-513195-18-00

Protocol code:

RECHMPL22_0123

NCT ID:

NCT05651841

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Tezepelumab for Patients with Severe Asthma

What is this study about?

Who Can Join the Study?

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