AsthmaT-ROSS-IINCT07013760
Characterize and Assess Clinical Outcomes of Patients Receiving Tezepelumab After Marketing Approval in Spain
An observational study of Asthma, run by AstraZeneca at 12 sites in Spain.
Trial summary
Observational retrospective study to characterize and assess clinical outcomes of patients receiving tezepelumab after marketing approval in Spain Read more about this study
- Who is it for?
- Ages 12 to 105 years
- Conditions the study is for
- Asthma
- How many people
- 420 participants
- Where
- 12 sitesSpain
- Study dates
- 23 Jun 2025to 19 Dec 2025
- 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 to 105 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Research Site
Andalucia
Research Site
C. Valenciana
Research Site
C. Y Leon
Research Site
Cantabria
Research Site
Castilla La Mancha
Research Site
Cataluna
Research Site
Extremadura
Research Site
Galicia
Research Site
Islas Canarias
Research Site
Madrid
Research Site
Navarra
Research Site
Pais Vasco
About this study
Official title: Observational Retrospective Study to Characterize and Assess Clinical Outcomes of Patients Receiving Tezepelumab After Marketing Approval in Spain
Observational retrospective study to characterize and assess clinical outcomes of patients receiving tezepelumab after marketing approval in Spain
Read the 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.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Index date (treatment initiation with tezepelumab)
Exacerbation (number of exacerbations)
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)
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: 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
Measured: 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)
Measured: Only on the baseline (12 months prior to Index date)
Secondary outcomes (10)
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 seores range from 5 (poor control of asthma) to 25 (complete control of osthmo), with higher seores reflecting greater asthma control. An ACT score >19 indicates well controlled asthma. The investigators 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)
Lung function measurements
Lung function measurements including spirometry (FEV1 (L))
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)
Blood neutrophil count (109 /L, mm^3)
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)
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 score range from 1 to 10. Scores from 0-1 indicate well controlled-asthma. From 2-4 no well-controlled and ≥ 5 bad control.
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)
It is a validated scale with 32 questions. 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 (Mini Asthma Quality of Life Questionnaire)
This instrument has 15 questions. 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)
SNOT-22 (Sino-Nasal Outcome Test)
It consists of 22 items, rated from 0 ('no problem at all') to 5 ('worst possible symptom'). Possible SNOT-22 total-scores range from 0 to 110, with higher SNOT-22 total-scores indicating worse symptoms.
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 (BEC) (109 /L, mm^3)
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.
- First posted10 Jun 2025
- Study start23 Jun 2025
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
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 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
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013760
- Sponsor's protocol ID
- D5180R00038
- Acronym
- T-ROSS-II
- Status last verified
- Jan 2026
- First submitted
- 4 Apr 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Domingo C, Monteagudo G, Ramos-Lima F, Alegria M, Niza G, Robles M, Dominguez-Ortega J. Characteristics and clinical outcomes of patients with severe asthma receiving tezepelumab after marketing approval in Spain (T-ROSS II study): an observational study protocol. BMJ Open. 2026 Jun 30;16(6):e115512. doi: 10.1136/bmjopen-2025-115512.
PubMed 42379714
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. 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 After Marketing Approval in Spain
- ClinicalTrials.gov ID
- NCT07013760
- Acronym / sponsor ID
- T-ROSS-II / D5180R00038
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 10 Jun 2025 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
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
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: Index date (treatment initiation with tezepelumab)
To describe the demographic characteristics of patients
Exacerbation (number of exacerbations)
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)
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: 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
Time frame: 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)
Time frame: Only on the baseline (12 months prior to Index date)
10 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)
Lung function measurements
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)
Blood neutrophil count (109 /L, mm^3)
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)
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 (Mini Asthma Quality of Life Questionnaire)
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)
SNOT-22 (Sino-Nasal Outcome 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)
Blood eosinophil count (BEC) (109 /L, mm^3)
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 12 Jan 2026.
- Derived from this study: PubMed 42379714Domingo C, Monteagudo G, Ramos-Lima F, Alegria M, Niza G, Robles M, Dominguez-Ortega J. Characteristics and clinical outcomes of patients with severe asthma receiving tezepelumab after marketing approval in Spain (T-ROSS II study): an observational study protocol. BMJ Open. 2026 Jun 30;16(6):e115512. doi: 10.1136/bmjopen-2025-115512.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by AstraZeneca at 12 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 4 inclusion and 2 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 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
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: Index date (treatment initiation with tezepelumab)). The study lists 5 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 NCT07013760, 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 12 Jan 2026.