Recruiting

Study of Tezepelumab effects on airway barrier function in patients with severe asthma, with or without chronic rhinosinusitis with nasal polyps

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 study focuses on patients with severe asthma, including those who also have chronic rhinosinusitis with nasal polyps. The research examines how a medication called tezepelumab affects the protective barriers in both the upper and lower airways. Chronic rhinosinusitis with nasal polyps is a condition where the sinuses become inflamed and growths develop in the nasal passages, while severe asthma is a breathing condition that causes airway inflammation and breathing difficulties.

The treatment involves receiving tezepelumab through injection. The medication will be given in doses up to 210 milligrams, with the total treatment period lasting up to 4 months. The total amount of medication received during the study will not exceed 840 milligrams.

The purpose of this study is to understand how tezepelumab affects the protective barrier of the airways in patients who have severe asthma, both with and without nasal polyps. The research will examine how the airways respond to various substances that can cause irritation. This will help researchers better understand how the medication works to protect the airways in these conditions.

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
Initial evaluation
Your eligibility for the study will be confirmed based on your severe asthma diagnosis and medical history.
A medical assessment will verify if you meet the criteria, including having uncontrolled asthma despite current treatment or requiring high doses of medication to control symptoms.
Your lung function will be tested to confirm that it is below 80% of predicted values.
Blood tests will check for specific markers, including a level of eosinophils (type of white blood cells) that meets study requirements.
Step 2
Medical examination
Your airways will be examined to assess mucus levels.
If you are in the polyp group, your nasal polyps will be confirmed through endoscopy or CT scan.
A CT scan will be performed to evaluate mucus buildup in your airways.
Step 3
Treatment administration
Tezepelumab will be administered through injection.
The treatment period will involve regular monitoring of your response to the medication.
Cell samples will be collected from your airways to study how the treatment affects the protective barrier of your respiratory system.
Step 4
Ongoing assessments
Regular tests will measure inflammation levels in your airways.
Samples will be analyzed to study changes in your airway cell composition.
The protective barrier function of your airway cells will be monitored throughout the study.
The study will continue until January 2027.

Who can join the trial?

15 criteria

Must provide written informed consent before any study procedures begin
Must be between 18 and 99 years old and willing to participate in the study
Must have a diagnosed asthma condition
Must be receiving treatment for severe asthma at treatment step 4 or 5
Must have at least one of these conditions:
- Asthma Control Test score less than 20 or Asthma Control Questionnaire score above 0.75
- Two courses of oral corticosteroids for at least 3 days in the past 12 months due to severe asthma
- One hospitalization due to asthma in the past 12 months
- Lung function test (FEV1) less than 80% of predicted value
- Must have a nitric oxide level in exhaled breath of 20 parts per billion or higher
- Must have either:
  - 250 or more eosinophils (type of white blood cell) per microliter in blood, or
  - 150 or more eosinophils during reduction of medication, or
  - More than 2% eosinophils in sputum or bronchial samples
  - For patients with nasal polyps: must have confirmation through nasal examination or CT scan
  - Must have a mucus score of 1 or higher
  - If previously treated with biological medications for asthma or polyps, must have stopped treatment for at least 3 months or 3 half-lives of the medication, whichever is longer

Who cannot join the trial?

15 criteria

Age below 18 years or above 65 years
Pregnancy or breastfeeding
Current smokers or those who quit smoking less than 6 months ago
Recent respiratory tract infection (within 4 weeks before the study)
Use of systemic corticosteroids (steroid medications taken as pills or injections) in the past 4 weeks
History of chronic lung diseases other than asthma
Uncontrolled high blood pressure
Significant heart, liver, or kidney disease
History of cancer in the past 5 years
Current participation in other clinical trials
Known allergies to Tezepelumab or similar medications
History of serious allergic reactions to any medications
Inability to perform breathing tests properly
Mental conditions that could interfere with following study procedures
Active autoimmune diseases (conditions where the immune system attacks the body's own tissues)

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Verified sites

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Verified
Medical University Of Vienna
Vienna, Austria

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Investigated drugs

Tezepelumab is a medication that helps treat severe asthma. It works by targeting a specific protein in the body that plays a role in airway inflammation. This medication is designed to help improve the protective barrier function in both the upper and lower airways, particularly in patients who have severe asthma with or without nasal polyps. It's given as a treatment to help reduce inflammation and improve breathing in people with severe asthma who may also have chronic sinus problems.

Tezepelumab

What is already known about the treatment

Tezepelumab - A biological medication administered through subcutaneous injection that represents a significant advancement in treating severe asthma and chronic rhinosinusitis with nasal polyps. This monoclonal antibody works by targeting thymic stromal lymphopoietin (TSLP), a key protein involved in airway inflammation, effectively blocking its interaction with immune cells and reducing inflammatory responses in the airways. As a member of the biological therapy class, Tezepelumab has demonstrated promising results in clinical trials for patients with severe asthma, particularly those with elevated T2 biomarkers, and has shown potential in improving respiratory barrier function and reducing asthma exacerbations.

Investigated diseases

Severe Asthma
A chronic respiratory condition characterized by inflammation and narrowing of the airways, making breathing difficult. The airways become extra sensitive to various triggers, leading to recurring episodes of wheezing, breathlessness, chest tightness, and coughing. In severe asthma, these symptoms are more intense and frequent than in mild or moderate asthma, occurring despite regular use of standard medications. The condition can fluctuate in intensity over time, with periods of relative stability interrupted by episodes of worsening symptoms.
Chronic Rhinosinusitis with Nasal Polyps
A persistent inflammatory condition of the nose and sinuses lasting 12 weeks or longer, characterized by the presence of soft, painless growths (polyps) in the nasal passages and sinuses. The condition causes nasal congestion, reduced sense of smell, excessive mucus production, and facial pressure. The polyps can gradually increase in size and number, leading to further blockage of the nasal passages and sinuses. The ongoing inflammation affects the normal drainage of the sinuses and can impact breathing through the nose.