Severe AsthmaTRAILBLAZENCT06455462
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
An observational study of Severe Asthma, run by AstraZeneca at 6 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Severe Asthma
- What is being tested?
- Tezepelumab
- How many people
- 352 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 22 Apr 2024to 25 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Research Site
Birmingham
Research Site
Liverpool
Research Site
London
Research Site
Newcastle
Research Site
Plymouth
Research Site
Southampton
About this study
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.
Read more
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.
- Conditions
- Severe Asthma
- Being tested
- Tezepelumab
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TezepelumabDrug
tezepelumab treatment initiated between 1st January 2023 and 31st March 2024
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualised exacerbation rate
Measured: 24 weeks, 52 weeks
Secondary outcomes (39)
Exacerbation rate during the baseline
Measured: Baseline (-52 to 0 weeks)
Change from baseline in annual exacerbation rate
Absolute and relative change will be described
Measured: Baseline (-52 to 0 weeks) to 52 weeks
Exacerbation rate by season
Measured: 52 weeks
Time to first exacerbation
Measured: 52 weeks
Proportion of patients recieving maintenance oral corticosteroids (mOCS) for asthma (y/n)
Measured: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Dose of mOCS for asthma
Measured: 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
Measured: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Summary measures of Asthma Control Questionnaire (ACQ-6) score
Measured: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Change since baseline in ACQ-6 score
Absolute and relative change will be described
Measured: Baseline (-52 to 0 weeks) to 52 weeks
Proportion achieving MCID change in ACQ-6
Measured: 52 weeks
Proportion achieving 2xMCID change in ACQ-6
Measured: 52 weeks
Quality of life measured by the Asthma Quality of Life Questionnaire (AQLQ)
AQLQ-12 or mini-AQLQ will be measured separately.
Measured: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Change from baseline in AQLQ score
Absolute and relative change will be described
Measured: Baseline (-52 to 0 weeks) to 52 weeks
Proportion achieving MCID change in AQLQ
Measured: 52 weeks
Proportion achieving 2xMCID change in AQLQ
Measured: 52 weeks
Summary measures of forced expiratory volume in 1 second (FEV1)
Measured: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Change from baseline in FEV1
Absolute and relative change will be described
Measured: Baseline (-52 to 0 weeks) and 52 weeks
Summary measures of % predicted FEV1
Measured: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Summary measures of FEV1/FVC
Measured: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Summary measures of fractional exhaled nitric oxide (FeNO, ppb)
Measured: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Change from baseline in FeNO
Absolute and relative change will be described
Measured: Baseline (-52 to 0 weeks) and 52 weeks
Hightest FeNO level (ppb) recorded in patient record
Measured: Any time prior to tezepelumab initiation
Summary measures of blood eosinophil count
Measured: 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
Measured: Baseline (-52 to 0 weeks) and 52 weeks
Hightest blood eosinophil count recorded in patient record
Measured: Any time prior to tezepelumab initiation
Summary measures of IgE
Measured: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Change from baseline in IgE
Absolute and relative change will be described
Measured: Baseline (-52 to 0 weeks) and 52 weeks
Hightest IgE level recorded in patient record
Measured: 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
Measured: Baseline (-52 to 0 weeks), 24 weeks and 52 weeks
Summary measures of inhaled corticosteroid (ICS) dose
Asthma-related ICS use will be described
Measured: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Proportion of patients with previous biologic use
Measured: Baseline (-52 to 0 weeks)
Number of previous biologics prior to tezepelumab initiation
Measured: Any time prior to tezepelumab initiation
Reason for tezepelumab initiation
Measured: Baseline (-52 to 0 weeks)
Time to tezepelumab discontinuation
Measured: Baseline (-52 to 0 weeks) to 52 weeks
Number, type and rate of asthma related hospitalisation events
Measured: Baseline (-52 to 0 weeks) to 52 weeks
Number and rate of asthma related A&E visits
Measured: Baseline (-52 to 0 weeks) to 52 weeks
Number and rate of asthma related ICU admissions
Measured: Baseline (-52 to 0 weeks) to 52 weeks
Number and rate of asthma related ventilator use
Measured: Baseline (-52 to 0 weeks) to 52 weeks
Number and rate of asthma related outpatient visits
Measured: Baseline (-52 to 0 weeks) to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start22 Apr 2024
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455462
- Sponsor's protocol ID
- D5180R00027
- Acronym
- TRAILBLAZE
- Status last verified
- Jan 2026
- First submitted
- 1 Mar 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06455462
- Acronym / sponsor ID
- TRAILBLAZE / D5180R00027
- Conditions
- Severe Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tezepelumabtezepelumab treatment initiated between 1st January 2023 and 31st March 2024 | Drug | – |
Primary outcome
Annualised exacerbation rate
Time frame: 24 weeks, 52 weeks
39 secondary outcomes
Exacerbation rate during the baseline
Time frame: Baseline (-52 to 0 weeks)
Change from baseline in annual exacerbation rate
Time frame: Baseline (-52 to 0 weeks) to 52 weeks
Exacerbation rate by season
Time frame: 52 weeks
Time to first exacerbation
Time frame: 52 weeks
Proportion of patients recieving maintenance oral corticosteroids (mOCS) for asthma (y/n)
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Dose of mOCS for asthma
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Change from baseline in dose of mOCS for asthma
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Summary measures of Asthma Control Questionnaire (ACQ-6) score
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Change since baseline in ACQ-6 score
Time frame: Baseline (-52 to 0 weeks) to 52 weeks
Proportion achieving MCID change in ACQ-6
Time frame: 52 weeks
Proportion achieving 2xMCID change in ACQ-6
Time frame: 52 weeks
Quality of life measured by the Asthma Quality of Life Questionnaire (AQLQ)
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Change from baseline in AQLQ score
Time frame: Baseline (-52 to 0 weeks) to 52 weeks
Proportion achieving MCID change in AQLQ
Time frame: 52 weeks
Proportion achieving 2xMCID change in AQLQ
Time frame: 52 weeks
Summary measures of forced expiratory volume in 1 second (FEV1)
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Change from baseline in FEV1
Time frame: Baseline (-52 to 0 weeks) and 52 weeks
Summary measures of % predicted FEV1
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Summary measures of FEV1/FVC
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Summary measures of fractional exhaled nitric oxide (FeNO, ppb)
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Change from baseline in FeNO
Time frame: Baseline (-52 to 0 weeks) and 52 weeks
Hightest FeNO level (ppb) recorded in patient record
Time frame: Any time prior to tezepelumab initiation
Summary measures of blood eosinophil count
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Change from baseline in blood eosinophil count (BEC)
Time frame: Baseline (-52 to 0 weeks) and 52 weeks
Hightest blood eosinophil count recorded in patient record
Time frame: Any time prior to tezepelumab initiation
Summary measures of IgE
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Change from baseline in IgE
Time frame: Baseline (-52 to 0 weeks) and 52 weeks
Hightest IgE level recorded in patient record
Time frame: Any time prior to tezepelumab initiation
Proportion of patients recieving treatment with LABA, LAMA or ICS
Time frame: Baseline (-52 to 0 weeks), 24 weeks and 52 weeks
Summary measures of inhaled corticosteroid (ICS) dose
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Proportion of patients with previous biologic use
Time frame: Baseline (-52 to 0 weeks)
Number of previous biologics prior to tezepelumab initiation
Time frame: Any time prior to tezepelumab initiation
Reason for tezepelumab initiation
Time frame: Baseline (-52 to 0 weeks)
Time to tezepelumab discontinuation
Time frame: Baseline (-52 to 0 weeks) to 52 weeks
Number, type and rate of asthma related hospitalisation events
Time frame: Baseline (-52 to 0 weeks) to 52 weeks
Number and rate of asthma related A&E visits
Time frame: Baseline (-52 to 0 weeks) to 52 weeks
Number and rate of asthma related ICU admissions
Time frame: Baseline (-52 to 0 weeks) to 52 weeks
Number and rate of asthma related ventilator use
Time frame: Baseline (-52 to 0 weeks) to 52 weeks
Number and rate of asthma related outpatient visits
Time frame: Baseline (-52 to 0 weeks) to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Asthma, run by AstraZeneca at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualised exacerbation rate (time frame: 24 weeks, 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.