Tezepelumab
Drugtezepelumab treatment initiated between 1st January 2023 and 31st March 2024
NCT Number: NCT06455462
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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Notify Me18 year–100 year
All sexes
Observational
Research Site, Birmingham, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
tezepelumab treatment initiated between 1st January 2023 and 31st March 2024
Time frame: 24 weeks, 52 weeks
Time frame: Baseline (-52 to 0 weeks)
Time frame: Baseline (-52 to 0 weeks) to 52 weeks
Absolute and relative change will be described
Time frame: 52 weeks
Time frame: 52 weeks
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Absolute and relative change will be described
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Time frame: Baseline (-52 to 0 weeks) to 52 weeks
Absolute and relative change will be described
Time frame: 52 weeks
Time frame: 52 weeks
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
AQLQ-12 or mini-AQLQ will be measured separately.
Time frame: Baseline (-52 to 0 weeks) to 52 weeks
Absolute and relative change will be described
Time frame: 52 weeks
Time frame: 52 weeks
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Time frame: Baseline (-52 to 0 weeks) and 52 weeks
Absolute and relative change will be described
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Time frame: Baseline (-52 to 0 weeks) and 52 weeks
Absolute and relative change will be described
Time frame: Any time prior to tezepelumab initiation
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Time frame: Baseline (-52 to 0 weeks) and 52 weeks
Absolute and relative change will be described
Time frame: Any time prior to tezepelumab initiation
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Time frame: Baseline (-52 to 0 weeks) and 52 weeks
Absolute and relative change will be described
Time frame: Any time prior to tezepelumab initiation
Time frame: Baseline (-52 to 0 weeks), 24 weeks and 52 weeks
Asthma related treatment with LABA, LAMA and/or ICS will be described
Time frame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
Asthma-related ICS use will be described
Time frame: Baseline (-52 to 0 weeks)
Time frame: Any time prior to tezepelumab initiation
Time frame: Baseline (-52 to 0 weeks)
Time frame: Baseline (-52 to 0 weeks) to 52 weeks
Time frame: Baseline (-52 to 0 weeks) to 52 weeks
Time frame: Baseline (-52 to 0 weeks) to 52 weeks
Time frame: Baseline (-52 to 0 weeks) to 52 weeks
Time frame: Baseline (-52 to 0 weeks) to 52 weeks
Time frame: Baseline (-52 to 0 weeks) to 52 weeks
AstraZeneca
Industry
Acronym: TRAILBLAZE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)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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