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

Observational retrospective study to characterize and assess clinical outcomes of patients receiving tezepelumab after marketing approval in Spain

Characterize and assess clinical outcomes of patients receiving tezepelumab after marketing approval in Spain

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.

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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 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

Lung function measurements including spirometry (FEV1 (L))

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.

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.

This instrument has 15 questions. The questions are scored on a scale of 1- 7, with higher scores indicating better quality of life.

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.

Characterize and assess clinical outcomes of patients receiving tezepelumab after marketing approval in Spain - T-ROSS-II

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