Clinical trial 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-06-12
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Annualised exacerbation rate
timeFrame: 24 weeks, 52 weeks
Secondary outcomes:
measure: Exacerbation rate during the baseline
timeFrame: Baseline (-52 to 0 weeks)
measure: Change from baseline in annual exacerbation rate
timeFrame: Baseline (-52 to 0 weeks) to 52 weeks
measure: Exacerbation rate by season
timeFrame: 52 weeks
measure: Time to first exacerbation
timeFrame: 52 weeks
measure: Proportion of patients recieving maintenance oral corticosteroids (mOCS) for asthma (y/n)
timeFrame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
measure: Dose of mOCS for asthma
timeFrame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
measure: Change from baseline in dose of mOCS for asthma
timeFrame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
measure: Summary measures of Asthma Control Questionnaire (ACQ-6) score
timeFrame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
measure: Change since baseline in ACQ-6 score
timeFrame: Baseline (-52 to 0 weeks) to 52 weeks
measure: Proportion achieving MCID change in ACQ-6
timeFrame: 52 weeks
measure: Proportion achieving 2xMCID change in ACQ-6
timeFrame: 52 weeks
measure: Quality of life measured by the Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
measure: Change from baseline in AQLQ score
timeFrame: Baseline (-52 to 0 weeks) to 52 weeks
measure: Proportion achieving MCID change in AQLQ
timeFrame: 52 weeks
measure: Proportion achieving 2xMCID change in AQLQ
timeFrame: 52 weeks
measure: Summary measures of forced expiratory volume in 1 second (FEV1)
timeFrame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
measure: Change from baseline in FEV1
timeFrame: Baseline (-52 to 0 weeks) and 52 weeks
measure: Summary measures of % predicted FEV1
timeFrame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
measure: Summary measures of FEV1/FVC
timeFrame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
measure: Summary measures of fractional exhaled nitric oxide (FeNO, ppb)
timeFrame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
measure: Change from baseline in FeNO
timeFrame: Baseline (-52 to 0 weeks) and 52 weeks
measure: Hightest FeNO level (ppb) recorded in patient record
timeFrame: Any time prior to tezepelumab initiation
measure: Summary measures of blood eosinophil count
timeFrame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
measure: Change from baseline in blood eosinophil count (BEC)
timeFrame: Baseline (-52 to 0 weeks) and 52 weeks
measure: Hightest blood eosinophil count recorded in patient record
timeFrame: Any time prior to tezepelumab initiation
measure: Summary measures of IgE
timeFrame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
measure: Change from baseline in IgE
timeFrame: Baseline (-52 to 0 weeks) and 52 weeks
measure: Hightest IgE level recorded in patient record
timeFrame: Any time prior to tezepelumab initiation
measure: Proportion of patients recieving treatment with LABA, LAMA or ICS
timeFrame: Baseline (-52 to 0 weeks), 24 weeks and 52 weeks
measure: Summary measures of inhaled corticosteroid (ICS) dose
timeFrame: Baseline (-52 to 0 weeks), after 24 and 52 weeks
measure: Proportion of patients with previous biologic use
timeFrame: Baseline (-52 to 0 weeks)
measure: Number of previous biologics prior to tezepelumab initiation
timeFrame: Any time prior to tezepelumab initiation
measure: Reason for tezepelumab initiation
timeFrame: Baseline (-52 to 0 weeks)
measure: Time to tezepelumab discontinuation
timeFrame: Baseline (-52 to 0 weeks) to 52 weeks
measure: Number, type and rate of asthma related hospitalisation events
timeFrame: Baseline (-52 to 0 weeks) to 52 weeks
measure: Number and rate of asthma related A&E visits
timeFrame: Baseline (-52 to 0 weeks) to 52 weeks
measure: Number and rate of asthma related ICU admissions
timeFrame: Baseline (-52 to 0 weeks) to 52 weeks
measure: Number and rate of asthma related ventilator use
timeFrame: Baseline (-52 to 0 weeks) to 52 weeks
measure: Number and rate of asthma related outpatient visits
timeFrame: Baseline (-52 to 0 weeks) to 52 weeks
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Newcastle
country: United Kingdom
facility: Research Site
city: Plymouth
country: United Kingdom
facility: Research Site
city: Southampton
country: United Kingdom
facility: Research Site
Study officials:
References: