Clinical trial NCT07013760: Characterize and Assess Clinical Outcomes of Patients Receiving Tezepelumab After Marketing Approval in Spain
Official title: Observational Retrospective Study to Characterize and Assess Clinical Outcomes of Patients Receiving Tezepelumab After Marketing Approval in Spain
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-06-10
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Maximum age (years): 105
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

Brief 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 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).

Primary outcomes:
measure: 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 )
timeFrame: Index date (treatment initiation with tezepelumab)
measure: Exacerbation (number of exacerbations)
timeFrame: 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)
measure: 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.)
timeFrame: From 12 months before index date until index date (defined as the date of treatment initiation with tezepelumab)
measure: Number of respiratory infections and diseases in the previous 12 months and index date
timeFrame: From 12 months before index date until index date (defined as the date of treatment initiation with tezepelumab)
measure: Number of participants with an Allergy test (Prick test, RAST or similar, clinical relevance of allergy, etc.) (only baseline)
timeFrame: Only on the baseline (12 months prior to Index date)
Secondary outcomes:
measure: Asthma Control Test (ACT)
timeFrame: 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)
measure: Lung function measurements
timeFrame: 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)
measure: FeNO (ppb)
timeFrame: 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)
measure: Blood neutrophil count (109 /L, mm^3)
timeFrame: 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)
measure: IgE (IU/mL)
timeFrame: 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)
measure: Asthma Impairment and Risk Questionnaire (AIRQ)
timeFrame: 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)
measure: Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: 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)
measure: MiniAQLQ (Mini Asthma Quality of Life Questionnaire)
timeFrame: 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)
measure: SNOT-22 (Sino-Nasal Outcome Test)
timeFrame: 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)
measure: Blood eosinophil count (BEC) (109 /L, mm^3)
timeFrame: 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)
Other outcomes:
Locations:
city: Cadiz
country: Spain
facility: Research site
state: Andalucia
city: Cordoba
country: Spain
facility: Research site
state: Andalucia
city: Granada
country: Spain
facility: Research site
state: Andalucia
city: Malaga
country: Spain
facility: Research site
state: Andalucia
city: Sevilla
country: Spain
facility: Research site
state: Andalucia
city: Alicante
country: Spain
facility: Research site
state: C. Valenciana
city: Valencia
country: Spain
facility: Research site
state: C. Valenciana
city: Segovia
country: Spain
facility: Research site
state: C. Y Leon
city: Santander
country: Spain
facility: Research site
state: Cantabria
city: Albacete
country: Spain
facility: Research site
state: Castilla La Mancha
city: Guadalajara
country: Spain
facility: Research site
state: Castilla La Mancha
city: Barcelona
country: Spain
facility: Research site
state: Cataluña
city: Badajoz
country: Spain
facility: Research site
state: Extremadura
city: Caceres
country: Spain
facility: Research site
state: Extremadura
city: A Coruña
country: Spain
facility: Research site
state: Galicia
city: Tenerife
country: Spain
facility: Research site
state: Islas Canarias
city: Pamplona
country: Spain
facility: Research site
state: Navarra
city: Bilbao
country: Spain
facility: Research site
state: Pais Vasco
city: Madrid
country: Spain
facility: Research site
Study officials:
References: