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Patient Characteristics, Treatment Patterns and Outcomes of Patients Enrolled in the Tezepelumab Patient Access Programme; a Retrospective, Observational Medical Chart Review Conducted in UK Severe Asthma Centres

Recruiting
18 - 100 years of age
Both
Phase N/A

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Overview

This is a retrospective, observational chart review that will include patients with severe asthma (SA) who have participated in the tezepelumab patient access programme (TPAP). Electronic case report forms (eCRFs) will be used for data abstraction of clinical information from the health records of patients enrolled in the TPAP from eight NHS acute trusts.

Approximately 200 patients with SA who took part in the TPAP with an index date (defined as the date of administration of the first dose of tezepelumab) between 1st January 2023 and 19th July 2023, and who meet the study eligibility criteria will be recruited to the study. Participation in the study does not affect the patients' treatment decisions since all data will be collected retrospectively from medical records. Key study definitions include:

  • Index date - the date of tezepelumab initiation (i.e., the date of first dose).
  • Pre-index period - defined as any time prior to tezepelumab initiation
  • Baseline period - defined as the 52 weeks prior to the index date
  • Outcomes period - defined as the 52 weeks post-index date.

Patients will be followed up from their index date until the first of the following events (whichever is first): reach 52 weeks post-index, they switch to a different biologic treatment, die, or are otherwise lost to follow-up.

Eligibility

Inclusion Criteria:

  • Patients enrolled on the TPAP who received their first dose of tezepelumab between 1st January 2023 and 19th July 2023
  • Patients aged ≥18 years at index

Exclusion Criteria:

  • Patients who received any biologic drug for the treatment of asthma in a clinical trial at any time during the 52 weeks prior to the index date.

Study details

Severe Asthma

NCT06455462

AstraZeneca

15 June 2024

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