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

NCT06487065 | Completed

• 1 other identifier: D5180R00028
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Severe Asthma

Outcome Measures

Primary Outcomes (11)

• Comorbidities (e.g., allergic rhinitis, nasal polyposis, gastroesophageal reflux, chronic obstructive pulmonary disease (COPD), atopic dermatitis and other eosinophilic conditions, conditions related to OCS chronic use, etc.)

  12 months before index date and index date (date of treatment initiation with tezepelumab)

• Number of respiratory infections and diseases in the previous 12 months and index date

  In the previous 12 months and index date (date of treatment initiation with tezepelumab)

• Exacerbations in the previous 12 months and Exacerbations from index date until all available follow-up (number and dates for each exacerbation episode)

  From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)

• When available, lung function measurements including spirometry, Inspiratory Capacity, and bronchodilator reversibility test.

  Lung function measurements including spirometry (FEV1(L), FVC(L), PEF(L/s), FEF25-75%(L/s), Inspiratory Capacity (IC) (L)), and bronchodilator reversibility test. From the spirometry measurements, the following will be calculated: FEV1/FVC ratio (%) and FEV1 % predicted (%)

  From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)

• Blood Eosinophil count (109 /L, mm3 )

  From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)

• IgE (IU/mL; kU/mL; ng/mL (mg/L); ng/dL (ng/100mL); ng%)

  From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)

• FeNO (ppb)

  From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)

• Allergy status (Prick test, RAST or similar, clinical relevance of allergy, etc.) (only baseline)

  Only on the baseline (12 months prior to Index date)

• Neutrophil count (10 9 /L, mm3 )

  From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)

• Sputum biomarkers: sputum eosinophils (%); sputum neutrophils (%)

  From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)

• Socio-demographic variables: Age (years), Gender (male, female, other); Smoking status (Current smoker, Ex-smoker, Non-smoker) and cumulative index (packs/year); Height (cm) and weight (kg); Body Mass Index (BMI) (kg/m 2 )

  To describe the demographic characteristics of patients

  Only on the index date (If no information referred to index date is available, latest available data before the index date)

Secondary Outcomes (4)

• Asthma Control Test (ACT)

  From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)

• Asthma Impairment and Risk Questionnaire (AIRQ)

  From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)

• Asthma Quality of Life Questionnaire (AQLQ)

  From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)

• MiniAQLQ

  From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will consist of all the subjects ≥ 12 years old who have received tezepelumab in the "Foreign medication supply" (FMS) program in Spain. However, some patients may have received tezepelumab under "Foreign medication supply" program as well as marketed tezepelumab, but all of them started while FMS program was in place

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (14)

Research Site

Alcázar de San Juan, Spain

Location

Research Site

Almería, Spain

Location

Research Site

Badajoz, Spain

Location

Research Site

Bilbao, Spain

Location

Research Site

Coslada, Spain

Location

Research Site

Donostia / San Sebastian, Spain

Location

Research Site

Fuenlabrada, Spain

Location

Research Site

Gran Canaria, Spain

Location

Research Site

Lugo, Spain

Location

Research Site

Madrid, Spain

Location

Research Site

Málaga, Spain

Location

Research Site

Talavera de la Reina, Spain

Location

Research Site

Torrejón de Ardoz, Spain

Location

Research Site

Valencia, Spain

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: July 5, 2024
• Study Start: June 17, 2024
• Primary Completion: October 25, 2024
• Study Completion: October 25, 2024
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

ES (14)