Characterize and Assess Clinical Outcomes of Patients Receiving Tezepelumab After Marketing Approval in Spain (T-ROSS-II)

AstraZeneca

Status: Completed

Conditions: Asthma

Study type: Observational

Funder types: Industry

Identifiers

NCT07013760

D5180R00038

Details and patient eligibility

About

Observational retrospective study to characterize and assess clinical outcomes of patients receiving tezepelumab after marketing approval in Spain

Full description

T-ROSS-II has been designed to conduct a new observational study to generate additional evidence on the use of tezepelumab in severe asthma patients in routine clinical practice in Spain after its launch.

This is an observational, multi-centre, retrospective, single-arm study in patients 12 years and older with severe asthma.

Approximately 400 patients meeting the study eligibility criteria will be included in the T-ROSS-II.

Enrollment: 420 patients

Sex: All

Ages: 12 to 105 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients who received at least 1 tezepelumab dose after commercialization in Spain diagnosed with severe asthma who are inadequately controlled with high-dose inhaled corticosteroids and a long-acting β2-agonist ± additional medications for asthma control.

• Patients aged ≥12 years at the index date.
• Patients with continuous enrolment in the data source for at least 12-months before the index date.
• Patients with at least three months of continuous enrolment in the data source after the index date.

Exclusion criteria

Patients who received tezepelumab or any biologic drug for the treatment of asthma in a clinical trial at any time during the 12-months prior to the index date*.

• Patients who had initiated 3 or more non-tezepelumab biologic treatment (omalizumab, mepolizumab, reslizumab, benralizumab and dupilumab) for severe asthma at any time prior to the index date).