The Inflammatory Profile of Exacerbations in Patients With Severe Asthma Receiving Tezepelumab: T… (NCT06666504) | Clinical Trial Compass
CompletedNot Applicable
The Inflammatory Profile of Exacerbations in Patients With Severe Asthma Receiving Tezepelumab: The TezEx Study
United Kingdom150 participantsStarted 2024-12-11
Plain-language summary
Tezepelumab is a treatment that is approved by NICE (National Institute for Health and Care Excellence, https://www.nice.org.uk/) for patients with severe asthma, that remains poorly controlled despite high dose inhaled glucocorticosteroid medication.
The goal of this observational study is to learn why some patients with severe asthma continue to have asthma flare ups despite being on tezepelumab.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who qualify for tezepelumab according to NICE eligibility criteria and yet to begin treatment or those patients within 36 weeks (+/-8 weeks) since their first dose of tezepelumab at the Guy's severe asthma centre.
* Age ≥ 18 and ≤ 80 years at tezepelumab initiation.
* Able and willing to provide written informed consent and to comply with the study protocol, including being able to attend for assessment during a symptomatic deterioration.
Exclusion Criteria:
* Other clinically significant medical disease that is likely, in the opinion of the investigator, to require a change in biologic therapy or impact the ability to participate in the study.
* History of current alcohol, drug, or chemical abuse or past abuse that would impair or risk the subject's full participation in the study, in the opinion of the investigator.
* Other severe eosinophilic lung disease including EGPA, chronic eosinophilic pneumonia and ABPA
* Severe bronchiectasis on CT causing daily sputum production
* Maintenance therapy with an antibiotic including azithromycin or doxycycline
* Inability to give written informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in blood and airway (sputum and nasosorption) levels of T1, T2, T17, or other pro-inflammatory mediators, biomarkers and/or cells including EPX (eosinophil peroxidase) measurements in patients with severe asthma treated with tezepelumab
Timeframe: From enrolment to one year post initiation of tezepelumab