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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:
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tezepelumab | Drug | tezepelumab treatment initiated between 1st January 2023 and 31st March 2024 |
| Measure | Description | Time Frame |
|---|---|---|
| Annualised exacerbation rate | 24 weeks, 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Exacerbation rate during the baseline | Baseline (-52 to 0 weeks) | |
| Change from baseline in annual exacerbation rate | Absolute and relative change will be described | Baseline (-52 to 0 weeks) to 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | United Kingdom | ||||
| Research Site |
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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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| Exacerbation rate by season | 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 |
| Dose of mOCS for asthma | 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 | Baseline (-52 to 0 weeks), after 24 and 52 weeks |
| Summary measures of Asthma Control Questionnaire (ACQ-6) score | Baseline (-52 to 0 weeks), after 24 and 52 weeks |
| Change since baseline in ACQ-6 score | Absolute and relative change will be described | Baseline (-52 to 0 weeks) to 52 weeks |
| Proportion achieving MCID change in ACQ-6 | 52 weeks |
| Proportion achieving 2xMCID change in ACQ-6 | 52 weeks |
| Quality of life measured by the Asthma Quality of Life Questionnaire (AQLQ) | AQLQ-12 or mini-AQLQ will be measured separately. | Baseline (-52 to 0 weeks), after 24 and 52 weeks |
| Change from baseline in AQLQ score | Absolute and relative change will be described | Baseline (-52 to 0 weeks) to 52 weeks |
| Proportion achieving MCID change in AQLQ | 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 |
| Change from baseline in FEV1 | Absolute and relative change will be described | Baseline (-52 to 0 weeks) and 52 weeks |
| Summary measures of % predicted FEV1 | Baseline (-52 to 0 weeks), after 24 and 52 weeks |
| Summary measures of FEV1/FVC | 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 |
| Change from baseline in FeNO | Absolute and relative change will be described | Baseline (-52 to 0 weeks) and 52 weeks |
| Hightest FeNO level (ppb) recorded in patient record | Any time prior to tezepelumab initiation |
| Summary measures of blood eosinophil count | 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 | Baseline (-52 to 0 weeks) and 52 weeks |
| Hightest blood eosinophil count recorded in patient record | Any time prior to tezepelumab initiation |
| Summary measures of IgE | Baseline (-52 to 0 weeks), after 24 and 52 weeks |
| Change from baseline in IgE | Absolute and relative change will be described | Baseline (-52 to 0 weeks) and 52 weeks |
| Hightest IgE level recorded in patient record | 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 | Baseline (-52 to 0 weeks), 24 weeks and 52 weeks |
| Summary measures of inhaled corticosteroid (ICS) dose | Asthma-related ICS use will be described | Baseline (-52 to 0 weeks), after 24 and 52 weeks |
| Proportion of patients with previous biologic use | Baseline (-52 to 0 weeks) |
| Number of previous biologics prior to tezepelumab initiation | Any time prior to tezepelumab initiation |
| Reason for tezepelumab initiation | Baseline (-52 to 0 weeks) |
| 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 |
| 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 |
| 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 |
| Liverpool |
| United Kingdom |
| Research Site | London | United Kingdom |
| Research Site | Newcastle | United Kingdom |
| Research Site | Plymouth | United Kingdom |
| Research Site | Southampton | United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000622721 | tezepelumab |
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