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
NCT Number: NCT06487065
Acronym: T-ROSS
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Severe Asthma
Sponsor: AstraZeneca
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-17
Completion Date: 2024-11-30
Locations: Hospital Universitario de Gran Canario Dr Negrin, Las Palmas, Canarias, Spain|Hospital La Mancha Centro, Alcazar de San Juan, Ciudad Real, Spain|Hospital de Donostia, San Sebastián, Guipuzcua, Spain|Hospital Universitario del Henares, Coslada, Madrid, Spain|Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain|Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain|Hospital Universitario de Torrejón, Torrejón de Ardoz, Madrid, Spain|Hospital Costa del Sol, Marbella, Malaga, Spain|Hospital Quirón de Marbella, Marbella, Malaga, Spain|Hospital de Poniente, Almería, Spain|Clínica Clideba, Badajoz, Spain|Hospital de Basurto, Bilbao, Spain|Hospital Puerta del Mar, Cadiz, Spain|Hospital Lucus Augusti, Lugo, Spain|Hospital Clínico Universitario San Carlos, Madrid, Spain|Hospital Universitario 12 de Octubre, Madrid, Spain|Hospital Universitario Infanta Leonor, Madrid, Spain|Hospital Virgen de la Victoria, Malaga, Spain|Hospital Nuestra Señora de Prado, Toledo, Spain|Hospital Arnau de Vilanova, Valencia, Spain|Hospital La Fe, Valencia, Spain

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.

Primary Outcome Measures: 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)|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)
Secondary Outcome Measures: 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, 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)