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Completed

NCT Number: NCT06455462

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Birmingham, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tezepelumab

Drug

tezepelumab treatment initiated between 1st January 2023 and 31st March 2024

Primary outcomes

  1. Annualised exacerbation rate

    Time frame: 24 weeks, 52 weeks

Secondary outcomes

  1. Exacerbation rate during the baseline

    Time frame: Baseline (-52 to 0 weeks)

  2. Change from baseline in annual exacerbation rate

    Time frame: Baseline (-52 to 0 weeks) to 52 weeks

    Absolute and relative change will be described

  3. Exacerbation rate by season

    Time frame: 52 weeks

  4. Time to first exacerbation

    Time frame: 52 weeks

  5. Proportion of patients recieving maintenance oral corticosteroids (mOCS) for asthma (y/n)

    Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks

  6. Dose of mOCS for asthma

    Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks

  7. Change from baseline in dose of mOCS for asthma

    Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks

    Absolute and relative change will be described

  8. Summary measures of Asthma Control Questionnaire (ACQ-6) score

    Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks

  9. Change since baseline in ACQ-6 score

    Time frame: Baseline (-52 to 0 weeks) to 52 weeks

    Absolute and relative change will be described

  10. Proportion achieving MCID change in ACQ-6

    Time frame: 52 weeks

  11. Proportion achieving 2xMCID change in ACQ-6

    Time frame: 52 weeks

  12. Quality of life measured by the Asthma Quality of Life Questionnaire (AQLQ)

    Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks

    AQLQ-12 or mini-AQLQ will be measured separately.

  13. Change from baseline in AQLQ score

    Time frame: Baseline (-52 to 0 weeks) to 52 weeks

    Absolute and relative change will be described

  14. Proportion achieving MCID change in AQLQ

    Time frame: 52 weeks

  15. Proportion achieving 2xMCID change in AQLQ

    Time frame: 52 weeks

  16. Summary measures of forced expiratory volume in 1 second (FEV1)

    Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks

  17. Change from baseline in FEV1

    Time frame: Baseline (-52 to 0 weeks) and 52 weeks

    Absolute and relative change will be described

  18. Summary measures of % predicted FEV1

    Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks

  19. Summary measures of FEV1/FVC

    Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks

  20. Summary measures of fractional exhaled nitric oxide (FeNO, ppb)

    Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks

  21. Change from baseline in FeNO

    Time frame: Baseline (-52 to 0 weeks) and 52 weeks

    Absolute and relative change will be described

  22. Hightest FeNO level (ppb) recorded in patient record

    Time frame: Any time prior to tezepelumab initiation

  23. Summary measures of blood eosinophil count

    Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks

  24. Change from baseline in blood eosinophil count (BEC)

    Time frame: Baseline (-52 to 0 weeks) and 52 weeks

    Absolute and relative change will be described

  25. Hightest blood eosinophil count recorded in patient record

    Time frame: Any time prior to tezepelumab initiation

  26. Summary measures of IgE

    Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks

  27. Change from baseline in IgE

    Time frame: Baseline (-52 to 0 weeks) and 52 weeks

    Absolute and relative change will be described

  28. Hightest IgE level recorded in patient record

    Time frame: Any time prior to tezepelumab initiation

  29. Proportion of patients recieving treatment with LABA, LAMA or ICS

    Time frame: Baseline (-52 to 0 weeks), 24 weeks and 52 weeks

    Asthma related treatment with LABA, LAMA and/or ICS will be described

  30. Summary measures of inhaled corticosteroid (ICS) dose

    Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks

    Asthma-related ICS use will be described

  31. Proportion of patients with previous biologic use

    Time frame: Baseline (-52 to 0 weeks)

  32. Number of previous biologics prior to tezepelumab initiation

    Time frame: Any time prior to tezepelumab initiation

  33. Reason for tezepelumab initiation

    Time frame: Baseline (-52 to 0 weeks)

  34. Time to tezepelumab discontinuation

    Time frame: Baseline (-52 to 0 weeks) to 52 weeks

  35. Number, type and rate of asthma related hospitalisation events

    Time frame: Baseline (-52 to 0 weeks) to 52 weeks

  36. Number and rate of asthma related A&E visits

    Time frame: Baseline (-52 to 0 weeks) to 52 weeks

  37. Number and rate of asthma related ICU admissions

    Time frame: Baseline (-52 to 0 weeks) to 52 weeks

  38. Number and rate of asthma related ventilator use

    Time frame: Baseline (-52 to 0 weeks) to 52 weeks

  39. Number and rate of asthma related outpatient visits

    Time frame: Baseline (-52 to 0 weeks) to 52 weeks

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: TRAILBLAZE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 12, 2024
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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