Observational Retrospective Study To Characterize and Assess Clinical Outcomes of Patients Receiving Tezepelumab in the Framework Of Use in Special Situations Prior to Commercialisation in Spain

NCT ID: NCT06487065

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-17

Study Completion Date

2024-10-25

Brief Summary

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The aim of this study is to provide the first results on the use of tezepelumab under clinical practice conditions in severe asthma patients who participated in the "foreign medication supply" program in Spain.

Detailed Description

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Conditions

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Severe Asthma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Subjects 12 years and older with severe asthma who were inadequately controlled with high dose inhaled corticosteroids plus another medicinal product
* Received at least one dose of tezepelumab under the FMS program, established according to Royal Decree 1015 / 2009 (prior to commercialization)

Exclusion Criteria

* Subjects having received tezepelumab or any other biologic for the treatment of asthma in the context of a clinical trial at any time during the 12 months prior to the index date.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Alcázar de San Juan, , Spain

Site Status

Research Site

Almería, , Spain

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Badajoz, , Spain

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Research Site

Bilbao, , Spain

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Research Site

Coslada, , Spain

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Research Site

Donostia / San Sebastian, , Spain

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Research Site

Fuenlabrada, , Spain

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Research Site

Gran Canaria, , Spain

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Research Site

Lugo, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Talavera de la Reina, , Spain

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Research Site

Torrejón de Ardoz, , Spain

Site Status

Research Site

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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D5180R00028

Identifier Type: -

Identifier Source: org_study_id

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