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NCT07013760 | RECRUITING | Asthma

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

AstraZeneca

Brief Summary:

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

Condition or disease

Asthma

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 400 participants
Official Title : Observational Retrospective Study to Characterize and Assess Clinical Outcomes of Patients Receiving Tezepelumab After Marketing Approval in Spain
Actual Study Start Date : 2025-06-23
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 12 Years to 105 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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).
Characterize and Assess Clinical Outcomes of Patients Receiving Tezepelumab After Marketing Approval in Spain

Location Details

NCT07013760

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

Spain, Spain

Research Site

Andalucia, Spain, Spain,

ACTIVE NOT RECRUITING

Spain, Spain

Research Site

Andalucia, Spain, Spain,

RECRUITING

Spain, Spain

Research Site

Valencian C., Spain, Spain,

ACTIVE NOT RECRUITING

Spain, Spain

Research Site

Valencian C., Spain, Spain,

NOT YET RECRUITING

Spain, Spain

Research Site

C. Y Leon, Spain, Spain,

NOT YET RECRUITING

Spain, Spain

Research Site

Cantabria, Spain, Spain,

NOT YET RECRUITING

Spain, Spain

Research Site

Castile La Mancha, Spain, Spain,

NOT YET RECRUITING

Spain, Spain

Research Site

Catalonia, Spain, Spain,

ACTIVE NOT RECRUITING

Spain, Spain

Research Site

Catalonia, Spain, Spain,

NOT YET RECRUITING

Spain, Spain

Research Site

Estremadura, Spain, Spain,

NOT YET RECRUITING

Spain, Spain

Research Site

Galicia, Spain, Spain,

NOT YET RECRUITING

Spain, Spain

Research Site

Canary Islands, Spain, Spain,

NOT YET RECRUITING

Spain, Spain

Research Site

Navarra, Spain, Spain,

NOT YET RECRUITING

Spain, Spain

Research Site

Vasco Country, Spain, Spain,

NOT YET RECRUITING

Spain,

Research Site

Madrid, Spain,

ACTIVE NOT RECRUITING

Spain,

Research Site

Madrid, Spain,