Severe AsthmaT-ROSSNCT06487065

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

An observational study of Severe Asthma, run by AstraZeneca at 14 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Severe Asthma
How many people: 33 participants
Where: 14 sitesSpain
Study dates: 17 Jun 2024to 25 Oct 2024
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Who may be able to join

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)

Who cannot join

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.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

Spain14 sites

Research Site
Alcázar de San Juan
Research Site
Almería
Research Site
Badajoz
Research Site
Bilbao
Research Site
Coslada
Research Site
Donostia / San Sebastian
Research Site
Fuenlabrada
Research Site
Gran Canaria
Research Site
Lugo
Research Site
Madrid
Research Site
Málaga
Research Site
Talavera de la Reina
Research Site
Torrejón de Ardoz
Research Site
Valencia

Other trials in Spain

About this study

Conditions: Severe Asthma
Medical subject headings: Asthma

What is being measured

The primary outcome is the main question the study is designed to answer.

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.)
Measured: 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
Measured: 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)
Measured: 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 (%)
Measured: 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 )
Measured: 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%)
Measured: 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)
Measured: 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)
Measured: Only on the baseline (12 months prior to Index date)
Neutrophil count (10 9 /L, mm3 )
Measured: 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 (%)
Measured: 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
Measured: 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)
A short, simple, patient-based tool for identifying subjects with poorly controlled asthma. ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well controlled asthma. We will use the Spanish validation
Measured: 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)
The AIRQ® is a patient assessment tool intended to help identify patients 12 years of age and older whose health may be at risk because of uncontrolled asthma. AIRQ® is a 10-item, equally weighted, yes/no composite asthma control questionnaire that includes 7 impairment and 3 risk items. AIRQ® was validated against a standard of ACT™. The combination of selected AIRQ® items and cut points of control demonstrated a sensitivity of 0.90 to identify patients whose asthma was well-controlled (cut point of ≥2), and a specificity of 0.96 to determine patients whose asthma was very poorly controlled (cut point of ≥5)
Measured: 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)
A disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease. It is a validated, 32-question, with 2-week recall, self-administered instrument where questions are grouped into four domains: activity limitations (12 items), symptoms (11 items), emotional functions (5 items) and environmental stimuli (4 items). The questions are scored on a scale of 1-7, with higher scores indicating better quality of life
Measured: 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
This instrument has 15 questions in the same domains as the original AQLQ and takes 3-4 minutes to complete. The MiniAQLQ has very good reliability, cross-sectional validity, responsiveness and longitudinal validity. Like the AQLQ, a change in score of greater than 0.5 can be considered clinically important
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jun 202425 Oct 2024

First posted5 Jul 2024
Study start17 Jun 2024
Primary completion25 Oct 2024
Study completion25 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Severe AsthmaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Retrospective
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06487065
Sponsor's protocol ID: D5180R00028
Acronym: T-ROSS
Status last verified: Sep 2025
First submitted: 23 May 2024
Last updated: 2 Oct 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No

Publications

Garcia Moguel I, Ramos-Lima F, Alegria Llorente M, Niza Fresno G, Robles Manueco M, Monteagudo Ruiz G, Velasco Garrido JL; T-ROSS Study Investigators. Tezepelumab in the Framework of Use in Special Situations Before Commercialization: T-ROSS, a Retrospective Real-world Study in Spain. Clin Ther. 2026 Jun;48(6):495-502. doi: 10.1016/j.clinthera.2026.03.016. Epub 2026 Apr 18.
PubMed 42002456

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Severe Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06487065
Acronym / sponsor ID: T-ROSS / D5180R00028
Conditions: Severe Asthma
Study type: Observational
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 17 Jun 2024 (actual)
Primary completion: 25 Oct 2024 (actual)
Study completion: 25 Oct 2024 (actual)
First posted: 5 Jul 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Retrospective

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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

Key inclusion criteria (2 listed)

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)

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.)
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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 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 (%)
Blood Eosinophil count (109 /L, mm3 )
Time frame: 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%)
Time frame: 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)
Time frame: 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)
Time frame: Only on the baseline (12 months prior to Index date)
Neutrophil count (10 9 /L, mm3 )
Time frame: 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 (%)
Time frame: 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 )
Time frame: Only on the index date (If no information referred to index date is available, latest available data before the index date)
To describe the demographic characteristics of patients

4 secondary outcomes

Asthma Control Test (ACT)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
Derived from this study: PubMed 42002456Garcia Moguel I, Ramos-Lima F, Alegria Llorente M, Niza Fresno G, Robles Manueco M, Monteagudo Ruiz G, Velasco Garrido JL; T-ROSS Study Investigators. Tezepelumab in the Framework of Use in Special Situations Before Commercialization: T-ROSS, a Retrospective Real-world Study in Spain. Clin Ther. 2026 Jun;48(6):495-502. doi: 10.1016/j.clinthera.2026.03.016. Epub 2026 Apr 18.
CSR SynopsisLink provided by the sponsor.

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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Asthma, run by AstraZeneca at 14 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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.) (time frame: 12 months before index date and index date (date of treatment initiation with tezepelumab)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06487065, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.