NCT06455462CompletedNot Applicable
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
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 352
- Locations
- 1
- Primary Endpoint
- Annualised exacerbation rate
Study Overview
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 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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Annualised exacerbation rate
Time Frame: 24 weeks, 52 weeks
Secondary Outcomes
- 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)
- Change from baseline in blood eosinophil count (BEC)(Baseline (-52 to 0 weeks) and 52 weeks)
- 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)
- 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)
- Change from baseline in annual exacerbation rate(Baseline (-52 to 0 weeks) to 52 weeks)
- 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)
- Proportion achieving MCID change in AQLQ(52 weeks)
- Change from baseline in FEV1(Baseline (-52 to 0 weeks) and 52 weeks)
- 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)
- 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)
- Change from baseline in AQLQ score(Baseline (-52 to 0 weeks) to 52 weeks)
- 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)
- Proportion of patients with previous biologic use(Baseline (-52 to 0 weeks))
- Change from baseline in FeNO(Baseline (-52 to 0 weeks) and 52 weeks)
- 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)
- 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)
Investigators
Study Sites (1)
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