Patient Characteristics, Treatment Patterns and Outcomes of Patients Enrolled in the Tezepelumab Patient Access Programme; a Retrospective, Observational Medical Chart Review Conducted in UK Severe Asthma Centres
- Conditions
- Severe Asthma
- Registration Number
- NCT06455462
- Lead Sponsor
- AstraZeneca
- 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 eight NHS acute trusts.
Approximately 200 patients with SA who took part in the TPAP with an index date (defined as the date of administration of the first dose of tezepelumab) between 1st January 2023 and 19th July 2023, and who meet the study eligibility criteria will be recruited to 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Patients enrolled on the TPAP who received their first dose of tezepelumab between 1st January 2023 and 19th July 2023
- Patients aged ≥18 years at index
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Annualised exacerbation rate 24 weeks, 52 weeks
- Secondary Outcome Measures
Name Time Method Exacerbation rate by season 52 weeks Change from baseline in dose of mOCS for asthma Baseline (-52 to 0 weeks), after 24 and 52 weeks Absolute and relative change will be described
Exacerbation rate during the baseline Baseline (-52 to 0 weeks) Summary measures of Asthma Control Questionnaire (ACQ-6) score Baseline (-52 to 0 weeks), after 24 and 52 weeks Proportion of patients with previous biologic use Baseline (-52 to 0 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 Proportion achieving MCID change in ACQ-6 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 Summary measures of blood eosinophil count Baseline (-52 to 0 weeks), after 24 and 52 weeks Proportion of patients recieving treatment with LABA, LAMA or ICS Baseline (-52 to 0 weeks), 24 weeks and 52 weeks Asthma related treatment with LABA, LAMA and/or ICS will be described
Change from baseline in annual exacerbation rate Baseline (-52 to 0 weeks) to 52 weeks Absolute and relative change will be described
Dose of mOCS for asthma Baseline (-52 to 0 weeks), after 24 and 52 weeks Change since baseline in ACQ-6 score Baseline (-52 to 0 weeks) to 52 weeks Absolute and relative change will be described
Proportion achieving MCID change in AQLQ 52 weeks Change from baseline in FEV1 Baseline (-52 to 0 weeks) and 52 weeks Absolute and relative change will be described
Change from baseline in blood eosinophil count (BEC) Baseline (-52 to 0 weeks) and 52 weeks Absolute and relative change will be described
Proportion achieving 2xMCID change in ACQ-6 52 weeks Summary measures of FEV1/FVC Baseline (-52 to 0 weeks), after 24 and 52 weeks Change from baseline in IgE Baseline (-52 to 0 weeks) and 52 weeks Absolute and relative change will be described
Hightest IgE level recorded in patient record Any time prior to tezepelumab initiation Quality of life measured by the Asthma Quality of Life Questionnaire (AQLQ) Baseline (-52 to 0 weeks), after 24 and 52 weeks AQLQ-12 or mini-AQLQ will be measured separately.
Change from baseline in AQLQ score Baseline (-52 to 0 weeks) to 52 weeks Absolute and relative change will be described
Summary measures of % predicted FEV1 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 Summary measures of IgE Baseline (-52 to 0 weeks), after 24 and 52 weeks Change from baseline in FeNO Baseline (-52 to 0 weeks) and 52 weeks Absolute and relative change will be described
Hightest FeNO level (ppb) recorded in patient record Any time prior to tezepelumab initiation Hightest blood eosinophil count recorded in patient record Any time prior to tezepelumab initiation Summary measures of inhaled corticosteroid (ICS) dose Baseline (-52 to 0 weeks), after 24 and 52 weeks Asthma-related ICS use will be described
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 Number of previous biologics prior to tezepelumab initiation Any time prior to tezepelumab initiation 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 Reason for tezepelumab initiation Baseline (-52 to 0 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
Trial Locations
- Locations (1)
Research Site
🇬🇧Southampton, United Kingdom