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)

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.

Study Overview

• Status: Completed
• Conditions: Severe Asthma
• Intervention / Treatment: Drug: Tezepelumab

• Study Type: Observational
• Enrollment (Actual): 352

Contacts and Locations

Study Locations

• United Kingdom
  • 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
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• 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

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Annualised exacerbation rate	24 weeks, 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exacerbation rate during the baseline		Baseline (-52 to 0 weeks)
Change from baseline in annual exacerbation rate	Absolute and relative change will be described	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
Dose of mOCS for asthma		Baseline (-52 to 0 weeks), after 24 and 52 weeks
Change from baseline in dose of mOCS for asthma	Absolute and relative change will be described	Baseline (-52 to 0 weeks), after 24 and 52 weeks
Summary measures of Asthma Control Questionnaire (ACQ-6) score		Baseline (-52 to 0 weeks), after 24 and 52 weeks
Change since baseline in ACQ-6 score	Absolute and relative change will be described	Baseline (-52 to 0 weeks) to 52 weeks
Proportion achieving MCID change in ACQ-6		52 weeks
Proportion achieving 2xMCID change in ACQ-6		52 weeks
Quality of life measured by the Asthma Quality of Life Questionnaire (AQLQ)	AQLQ-12 or mini-AQLQ will be measured separately.	Baseline (-52 to 0 weeks), after 24 and 52 weeks
Change from baseline in AQLQ score	Absolute and relative change will be described	Baseline (-52 to 0 weeks) to 52 weeks
Proportion achieving MCID change in AQLQ		52 weeks
Proportion achieving 2xMCID change in AQLQ		52 weeks
Summary measures of forced expiratory volume in 1 second (FEV1)		Baseline (-52 to 0 weeks), after 24 and 52 weeks
Change from baseline in FEV1	Absolute and relative change will be described	Baseline (-52 to 0 weeks) and 52 weeks
Summary measures of % predicted FEV1		Baseline (-52 to 0 weeks), after 24 and 52 weeks
Summary measures of FEV1/FVC		Baseline (-52 to 0 weeks), after 24 and 52 weeks
Summary measures of fractional exhaled nitric oxide (FeNO, ppb)		Baseline (-52 to 0 weeks), after 24 and 52 weeks
Change from baseline in FeNO	Absolute and relative change will be described	Baseline (-52 to 0 weeks) and 52 weeks
Hightest FeNO level (ppb) recorded in patient record		Any time prior to tezepelumab initiation
Summary measures of blood eosinophil count		Baseline (-52 to 0 weeks), after 24 and 52 weeks
Change from baseline in blood eosinophil count (BEC)	Absolute and relative change will be described	Baseline (-52 to 0 weeks) and 52 weeks
Hightest blood eosinophil count recorded in patient record		Any time prior to tezepelumab initiation
Summary measures of IgE		Baseline (-52 to 0 weeks), after 24 and 52 weeks
Change from baseline in IgE	Absolute and relative change will be described	Baseline (-52 to 0 weeks) and 52 weeks
Hightest IgE level recorded in patient record		Any time prior to tezepelumab initiation
Proportion of patients recieving treatment with LABA, LAMA or ICS	Asthma related treatment with LABA, LAMA and/or ICS will be described	Baseline (-52 to 0 weeks), 24 weeks and 52 weeks
Summary measures of inhaled corticosteroid (ICS) dose	Asthma-related ICS use will be described	Baseline (-52 to 0 weeks), after 24 and 52 weeks
Proportion of patients with previous biologic use		Baseline (-52 to 0 weeks)
Number of previous biologics prior to tezepelumab initiation		Any time prior to tezepelumab initiation
Reason for tezepelumab initiation		Baseline (-52 to 0 weeks)
Time to tezepelumab discontinuation		Baseline (-52 to 0 weeks) to 52 weeks
Number, type and rate of asthma related hospitalisation events		Baseline (-52 to 0 weeks) to 52 weeks
Number and rate of asthma related A&E visits		Baseline (-52 to 0 weeks) to 52 weeks
Number and rate of asthma related ICU admissions		Baseline (-52 to 0 weeks) to 52 weeks
Number and rate of asthma related ventilator use		Baseline (-52 to 0 weeks) to 52 weeks
Number and rate of asthma related outpatient visits		Baseline (-52 to 0 weeks) to 52 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2024
• Primary Completion (Actual): November 25, 2025
• Study Completion (Actual): November 25, 2025

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; tezepelumab
• Other Study ID Numbers: D5180R00027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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
• IPD Sharing 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.