Patient Characteristics, Treatment Patterns and Outcomes of Patients With Severe Asthma Treated With Tezepelumab in the Real World; a Retrospective, Observational Medical Chart Review Conducted in UK Severe Asthma Centres
TRAILBLAZE
1 other identifier
observational
352
1 country
6
Brief Summary
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 up to eleven NHS trusts. Approximately 350 patients with an index date (defined as the date of administration of the first dose of tezepelumab) between 1st January 2023 and 19th July 2023 (patients enrolled in the patient access programme), and between 20th July 2023 and 31st March 2024 (patients receiving tezepelumab in routine care), and meet the study eligibility criteria will be included in 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2024
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2024
CompletedStudy Start
First participant enrolled
April 22, 2024
CompletedFirst Posted
Study publicly available on registry
June 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2025
CompletedJanuary 21, 2026
January 1, 2026
1.6 years
March 1, 2024
January 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Annualised exacerbation rate
24 weeks, 52 weeks
Secondary Outcomes (39)
Exacerbation rate during the baseline
Baseline (-52 to 0 weeks)
Change from baseline in annual exacerbation rate
Baseline (-52 to 0 weeks) to 52 weeks
Exacerbation rate by season
52 weeks
Time to first exacerbation
52 weeks
Proportion of patients recieving maintenance oral corticosteroids (mOCS) for asthma (y/n)
Baseline (-52 to 0 weeks), after 24 and 52 weeks
- +34 more secondary outcomes
Interventions
tezepelumab treatment initiated between 1st January 2023 and 31st March 2024
Eligibility Criteria
Patients with SA treated with tezepelumab as part of the TPAP (who received their first dose between 1st January 2023 and 19th July 2023) or post-TPAP (between 20th July 2023 and 31st March 2024) will be included in the study.
You may qualify if:
- Patients who received their first dose of tezepelumab between 1st January 2023 and 19th July 2023 (TPAP cohort) or between 20th July 2023 and 31st March 2024 (post-TPAP cohort)
- Patients aged ≥18 years at index
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (6)
Research Site
Birmingham, United Kingdom
Research Site
Liverpool, United Kingdom
Research Site
London, United Kingdom
Research Site
Newcastle, United Kingdom
Research Site
Plymouth, United Kingdom
Research Site
Southampton, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2024
First Posted
June 12, 2024
Study Start
April 22, 2024
Primary Completion
November 25, 2025
Study Completion
November 25, 2025
Last Updated
January 21, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.