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Tezepelumab Effects on TSLP Protein Induction in Adults with Severe Asthma, With and Without Chronic Rhinosinusitis

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

The study focuses on people who have Severe asthma, a condition in which the airways are constantly narrowed and inflamed, making breathing difficult. Some participants also have chronic rhinosinusitis, a long‑lasting inflammation of the nose and sinus cavities that often occurs together with asthma. The medication being tested is tezepelumab, sold under the brand name Tezspire, and it is given by a subcutaneous injection, which means the drug is placed just under the skin using a small needle.

The purpose of the research is to compare how a protein called TSLP is produced in airway cells after they are exposed to a laboratory substance that mimics a virus, known as poly(I:C). Participants will have samples taken from their nose and lungs at the start of the study, receive the study medication, and then provide additional samples at later visits. The collected cells are placed in a lab where they are exposed to the viral mimic, and researchers measure changes in the amount of TSLP protein and its genetic instructions (mRNA). The study also looks at other cells involved in allergy and inflammation, such as eosinophils (a type of white blood cell) and mast cells (cells that release chemicals during allergic reactions), to see how they respond over time.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline visit and first medication dose
After joining the study, attend the baseline visit where the first dose of Tezspire is given as a 210 mg subcutaneous injection. the injection is administered using a pre‑filled pen or syringe as provided by the study.
During the same visit, nasal and bronchial epithelial cells are collected. these cells are exposed in the laboratory to poly(I:C), a substance that mimics a viral infection.
The amount of TSLP protein produced by the cells is measured after 24 hours, and the amount of TSLP mRNA is measured after 3 hours. the results are recorded for comparison.
Step 2
Scheduled follow‑up visits and continued medication
Receive additional doses of Tezspire 210 mg by subcutaneous injection according to the study schedule. each dose follows the same method as the first injection.
Attend follow‑up visits where health status is checked and any side effects are reported.
Step 3
Visit 4 – bronchial biopsy and additional measurements
At the fourth scheduled visit, a bronchial mucosal biopsy is performed. this procedure collects tissue from the airways to evaluate markers of eosinophilic activation and mast cell phenotypes.
The collected tissue is compared with the baseline measurements to assess changes over time.
Step 4
Final assessment and study completion
Complete any remaining study procedures, including final health evaluations and collection of required samples.
The study ends after all scheduled visits and measurements are finished.

Who can join the trial?

6 criteria

You have been diagnosed with severe asthma (a serious form of asthma that is difficult to control).
You are 18 years of age or older.
Your doctor has decided to start treatment with tezepelumab, a medicine used for severe asthma, following all required guidelines.
You can sign a written informed consent form, meaning you understand the study and agree to take part, and you can follow the study visits and procedures.
You have already taken part in the 3TR‑ABC study at the Bispebjerg location and completed the 1‑year follow‑up visit.
You are willing to provide special samples of nasal and/or bronchial epithelial cells (cells from the lining of the nose or lungs) at a time before any other sampling (bio‑naïve baseline).

Who cannot join the trial?

8 criteria

Allergy to the medicine called tezepelumab or any of its inactive ingredients (called excipients). An allergy means your body reacts badly to the drug.
Having taken part in another clinical trial that tests a new treatment, or having used any experimental medicine, within the last 3 months (or for a longer time if the drug stays in the body for a long period, measured by its “half‑life”).
Being involved in any other study that the doctor thinks could affect the results of this research.
Having another serious health problem that is not well‑controlled and might need a change in treatment or make it hard for you to take part in the study.
Not being willing or able to follow the study’s procedures and tests, according to the doctor’s judgment.
Having poor‑quality samples from your airways (the tubes that carry air to and from your lungs) that cannot be used for the planned laboratory tests.
Choosing to withdraw permission for your samples to be used in future research related to the 3TR‑ABC study.
Being pregnant or possibly pregnant, or breastfeeding, at the time of the screening visit. For women who could become pregnant, a urine pregnancy test must be negative before joining the study.

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Verified sites

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Rigshospitalet
Verified
Copenhagen, Denmark

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Investigated drugs

Tezspire
is a medication that contains a laboratory‑made protein designed to block a natural substance in the body called TSLP. TSLP is involved in causing inflammation in the airways of people with severe asthma. By blocking TSLP, Tezspire may help reduce asthma symptoms and inflammation. In this study, the drug is given as a liquid that is injected just under the skin using a pre‑filled pen.
Tezspire
is the same medicine as described above, but in this part of the trial it is administered with a pre‑filled syringe instead of a pen. The injection is also placed just under the skin. The purpose is the same: to see how blocking TSLP affects the airway lining in people with severe asthma, with or without chronic sinus problems.

Tezepelumab

What is already known about the treatment

Tezspire 210 mg solution for injection in pre-filled pen
This medication is given as a subcutaneous injection using a pre‑filled pen, delivering a single dose of 210 mg. It is an approved biologic that has been studied in many clinical trials and is listed in current medical literature. The drug is used to treat severe asthma by blocking a protein called TSLP that triggers airway inflammation. It belongs to the class of monoclonal antibodies that target specific immune signals.
Tezspire 210 mg solution for injection in pre‑filled syringe
This medication is administered as a subcutaneous injection with a pre‑filled syringe, providing a 210 mg dose. It is an approved biologic with extensive research and is recognized in modern medical references. The main use is for severe asthma, where it blocks the TSLP protein to reduce inflammation in the lungs. It is classified as a monoclonal antibody that interferes with a specific immune pathway.

Investigated diseases

Severe asthma
A chronic lung condition characterized by frequent wheezing, shortness of breath, and chest tightness that require high‑dose inhaled or oral medications. The airways become inflamed and narrowed, leading to recurrent flare‑ups. Over time, repeated inflammation can cause thickening of the airway wall and reduced lung function. Symptoms may worsen with exposure to allergens, infections, or exercise. The disease persists despite standard therapy and often limits daily activities.
Chronic rhinosinusitis
A long‑lasting inflammation of the nasal passages and sinus cavities that lasts at least 12 weeks. It causes nasal congestion, thick nasal discharge, facial pressure, and reduced sense of smell. The condition may involve growth of nasal polyps and can flare up repeatedly. Persistent inflammation can lead to structural changes in the sinus lining. Symptoms often fluctuate but tend to become more troublesome over time.