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

Severe Asthma Clinical Trial

— TPAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06455462
• Other study ID #: D5180R00027
• Status: Recruiting
• Start date: April 22, 2024
• Est. completion date: September 23, 2024

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 23, 2024
• Est. primary completion date: September 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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

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.

Related Conditions & MeSH terms

• Asthma
• Severe Asthma

Intervention

Drug:
• Tezepelumab
tezepelumab treatment initiated as part of the tezepelumab patient access programme (TPAP) between 1st January 2023 and 19th July 2023

Locations

Country	Name	City	State
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Liverpool
United Kingdom	Research Site	London
United Kingdom	Research Site	Plymouth
United Kingdom	Research Site	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annualised exacerbation rate		24 weeks, 52 weeks
Secondary	Exacerbation rate during the baseline		Baseline (-52 to 0 weeks)
Secondary	Change from baseline in annual exacerbation rate	Absolute and relative change will be described	Baseline (-52 to 0 weeks) to 52 weeks
Secondary	Exacerbation rate by season		52 weeks
Secondary	Time to first exacerbation		52 weeks
Secondary	Proportion of patients recieving maintenance oral corticosteroids (mOCS) for asthma (y/n)		Baseline (-52 to 0 weeks), after 24 and 52 weeks
Secondary	Dose of mOCS for asthma		Baseline (-52 to 0 weeks), after 24 and 52 weeks
Secondary	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
Secondary	Summary measures of Asthma Control Questionnaire (ACQ-6) score		Baseline (-52 to 0 weeks), after 24 and 52 weeks
Secondary	Change since baseline in ACQ-6 score	Absolute and relative change will be described	Baseline (-52 to 0 weeks) to 52 weeks
Secondary	Proportion achieving MCID change in ACQ-6		52 weeks
Secondary	Proportion achieving 2xMCID change in ACQ-6		52 weeks
Secondary	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
Secondary	Change from baseline in AQLQ score	Absolute and relative change will be described	Baseline (-52 to 0 weeks) to 52 weeks
Secondary	Proportion achieving MCID change in AQLQ		52 weeks
Secondary	Proportion achieving 2xMCID change in AQLQ		52 weeks
Secondary	Summary measures of forced expiratory volume in 1 second (FEV1)		Baseline (-52 to 0 weeks), after 24 and 52 weeks
Secondary	Change from baseline in FEV1	Absolute and relative change will be described	Baseline (-52 to 0 weeks) and 52 weeks
Secondary	Summary measures of % predicted FEV1		Baseline (-52 to 0 weeks), after 24 and 52 weeks
Secondary	Summary measures of FEV1/FVC		Baseline (-52 to 0 weeks), after 24 and 52 weeks
Secondary	Summary measures of fractional exhaled nitric oxide (FeNO, ppb)		Baseline (-52 to 0 weeks), after 24 and 52 weeks
Secondary	Change from baseline in FeNO	Absolute and relative change will be described	Baseline (-52 to 0 weeks) and 52 weeks
Secondary	Hightest FeNO level (ppb) recorded in patient record		Any time prior to tezepelumab initiation
Secondary	Summary measures of blood eosinophil count		Baseline (-52 to 0 weeks), after 24 and 52 weeks
Secondary	Change from baseline in blood eosinophil count (BEC)	Absolute and relative change will be described	Baseline (-52 to 0 weeks) and 52 weeks
Secondary	Hightest blood eosinophil count recorded in patient record		Any time prior to tezepelumab initiation
Secondary	Summary measures of IgE		Baseline (-52 to 0 weeks), after 24 and 52 weeks
Secondary	Change from baseline in IgE	Absolute and relative change will be described	Baseline (-52 to 0 weeks) and 52 weeks
Secondary	Hightest IgE level recorded in patient record		Any time prior to tezepelumab initiation
Secondary	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
Secondary	Summary measures of inhaled corticosteroid (ICS) dose	Asthma-related ICS use will be described	Baseline (-52 to 0 weeks), after 24 and 52 weeks
Secondary	Proportion of patients with previous biologic use		Baseline (-52 to 0 weeks)
Secondary	Number of previous biologics prior to tezepelumab initiation		Any time prior to tezepelumab initiation
Secondary	Reason for tezepelumab initiation		Baseline (-52 to 0 weeks)
Secondary	Time to tezepelumab discontinuation		Baseline (-52 to 0 weeks) to 52 weeks
Secondary	Number, type and rate of asthma related hospitalisation events		Baseline (-52 to 0 weeks) to 52 weeks
Secondary	Number and rate of asthma related A&E visits		Baseline (-52 to 0 weeks) to 52 weeks
Secondary	Number and rate of asthma related ICU admissions		Baseline (-52 to 0 weeks) to 52 weeks
Secondary	Number and rate of asthma related ventilator use		Baseline (-52 to 0 weeks) to 52 weeks
Secondary	Number and rate of asthma related outpatient visits		Baseline (-52 to 0 weeks) to 52 weeks