A Study for Observing Severe Asthma in Patients Treated With Tezepelumab

AstraZeneca

Status: Active, not recruiting

Conditions: Asthma

Treatments: Other: None (Observational Study)

Study type: Observational

Funder types: Industry

Identifiers

NCT05677139

D5180R00011

Details and patient eligibility

About

A study involving primary data collection within real-world settings of participants who initiate treatment with tezepelumab for severe uncontrolled asthma. This study will complement evidence obtained from randomized controlled trials and provide new data focusing on the holistic and patient reported outcome (PRO).

Full description

This is a 12-month, multi-country, multi-center, prospective, non-comparative and non-interventional (observational), post-reimbursement real-world evidence study that will assess asthma symptom control, lung function, and patient-reported outcomes including health-related quality of life after tezepelumab treatment initiation in participants with severe asthma in Europe and Canada. This study is planned to be conducted in several countries including but not limited to Canada, Germany, Denmark, Switzerland, and Sweden.

Participants will be followed for a maximum period of 52 weeks after tezepelumab treatment initiation, irrespective of treatment discontinuation.

Enrollment: 513 patients

Sex: All

Ages: 12 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female participants aged 12 years or older
• Provision of signed and dated written informed consent, including assent for minors
• Prescribed treatment with Tezepelumab
• Diagnosis of asthma for at least 52 weeks prior to enrolment date and symptoms confirmed by the Investigator not to be due to alternative diagnoses
• Received at least one prescription of medium-dose to high-dose inhaled corticosteroids (ICS) during the 52 weeks prior to enrolment date
• Use of additional asthma maintenance controller medication(s) for at least 52 weeks prior to enrolment date
• Documented history of at least 1 asthma exacerbations during the 52 weeks prior to enrolment date
• Individuals with ACQ-6 score ≥ 1.5 (indicating inadequate asthma symptom control) at enrolment or up to 12 weeks before enrolment
• Participants currently receiving care from pulmonologists and/or allergists
• Participants who are able to understand and complete the ePROs
• Availability of participants medical records for asthma exacerbation and Healthcare Resource Utilization (HCRU) for the 52 weeks prior to Tezepelumab initiation

Exclusion criteria

• Any contraindication to Tezepelumab
• Participants on concurrent biologics for asthma at the time of receiving the first dose of Tezepelumab will be excluded except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment)
• Participation in an observational study that might, in the Investigator's opinion, influence the assessment for the current study, or participation in an interventional clinical trial in the last 3 months
• Pregnancy or lactation period.

Trial design

513 participants in 1 patient group

Prospective Cohort

Description:

Participants with severe uncontrolled asthma will receive tezepelumab. Relevant demographics, baseline clinical data, and asthma control questionnaire-6 (ACQ-6) will be retrospectively collected. All patient reported outcomes (PROs) will be prospectively collected. Other outcomes of interest (tezepelumab patterns of utilization, lung function, asthma exacerbations, medication use, and healthcare resource utilization \[HRU\]) will be collected at baseline (retrospective collection for 52-week pre-index period during enrolment) and prospectively collected during enrolment for participants who enroll into the study before the first dose of tezepelumab, and for a period of up to 52 weeks (at Weeks 4, 12, 24, and 52) after the index date. The index date is defined as the date when participants receive the first dose of tezepelumab.

Treatment:

Other: None (Observational Study)