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The Inflammatory Profile of Exacerbations in Patients With Severe Asthma Receiving Tezepelumab: The TezEx Study

CompletedN/A

Sponsor: Guy's and St Thomas' NHS Foundation Trust

Conditions: Severe Asthma

Interventions: Prospective Data Analysis

Countries: United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (1)

London, London, United Kingdom