Loading clinical trials...

Characterize and Assess Clinical Outcomes of Patients Receiving Tezepelumab After Marketing Approval in Spain | Clinical Trials | Clareo Health

COMPLETED

Characterize and Assess Clinical Outcomes of Patients Receiving Tezepelumab After Marketing Approval in Spain

Observational Retrospective Study to Characterize and Assess Clinical Outcomes of Patients Receiving Tezepelumab After Marketing Approval in Spain

NCT07013760•AstraZeneca

View on ClinicalTrials.gov

Summary

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

Detailed 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.

Eligibility

Age

12 - 105 years

Sex

ALL

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).

Locations (12)

Research Site

Andalucia, Spain

Research Site

C. Valenciana, Spain

Research Site

C. Y Leon, Spain

Research Site

Cantabria, Spain

Research Site

Castilla La Mancha, Spain

Research Site

Cataluna, Spain

Research Site

Extremadura, Spain

Research Site

Galicia, Spain

Research Site

Islas Canarias, Spain

Research Site

Madrid, Spain

Key Dates

Start Date

June 23, 2025

Primary Completion Date

December 19, 2025

Completion Date

December 19, 2025

Last Updated

January 12, 2026

Enrollment

420

ACTUAL participants

Conditions

Asthma

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

View study

RECRUITING

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Characterize and Assess Clinical Outcomes of Patients Receiving Tezepelumab After Marketing Approval in Spain

Inclusion Criteria

Exclusion Criteria

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma