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

NCT07013760 | Completed

• 1 other identifier: D5180R00038
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (5)

• 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

  Index date (treatment initiation with tezepelumab)

• Exacerbation (number of exacerbations)

  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)

• 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.)

  From 12 months before index date until index date (defined as the date of treatment initiation with tezepelumab)

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

  From 12 months before index date until index date (defined as the date of treatment initiation with tezepelumab)

• Number of participants with an Allergy test (Prick test, RAST or similar, clinical relevance of allergy, etc.) (only baseline)

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

Secondary Outcomes (10)

• 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)

• Lung function measurements

  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)

• Blood neutrophil count (109 /L, mm^3)

  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)

  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 - 105 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 patients ≥ 12 years old who have received tezepelumab according to the usual clinical practice under the discretion of the physician according with the European SmPc and the reimbursement conditions in Spain between October 1st 2023 and 12 months before the site initiation, who meet all the inclusion criteria and none of the exclusion criteria

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (12)

Research Site

Andalucia, Spain

Location

Research Site

C. Valenciana, Spain

Location

Research Site

C. Y Leon, Spain

Location

Research Site

Cantabria, Spain

Location

Research Site

Castilla La Mancha, Spain

Location

Research Site

Cataluna, Spain

Location

Research Site

Extremadura, Spain

Location

Research Site

Galicia, Spain

Location

Research Site

Islas Canarias, Spain

Location

Research Site

Madrid, Spain

Location

Research Site

Navarra, Spain

Location

Research Site

Pais Vasco, Spain

Location

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: April 4, 2025
• First Posted: June 10, 2025
• Study Start: June 23, 2025
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

ES (12)