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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Alcázar de San Juan | Spain | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42002456 | Derived | 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. |
| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| 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) |
| 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) | 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 | 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 | 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) |
| Almería |
| Spain |
| Research Site | Badajoz | Spain |
| Research Site | Bilbao | Spain |
| Research Site | Coslada | Spain |
| Research Site | Donostia / San Sebastian | Spain |
| Research Site | Fuenlabrada | Spain |
| Research Site | Gran Canaria | Spain |
| Research Site | Lugo | Spain |
| Research Site | Madrid | Spain |
| Research Site | Málaga | Spain |
| Research Site | Talavera de la Reina | Spain |
| Research Site | Torrejón de Ardoz | Spain |
| Research Site | Valencia | Spain |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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