EU Clinical Trial Information System (CTIS)

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

D5180R00028_CSR_Synopsis.pdf

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.

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

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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 (%)

To describe the demographic characteristics of patients

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

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)

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

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

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 - T-ROSS

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