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Characteristics of Type 2- High Inflammatory Endotype of Asthma Using New Biomarkers From Peripheral Blood and Exhaled Air and Its Effect on the Outcome of Therapy

NCT05270278

CompletedN/A

Sponsor: Value Outcomes Ltd.

Conditions: Asthma; Eosinophilic, Asthma Chronic, Bronchial Asthma, Asthma, Bronchial

Countries: Czechia

The goal of this study is to identify reliable, valid, easily measurable, interpretable, and useful biomarkers in peripheral blood and exhaled air by people with severe asthma for a more accurate description of the pathogenetic processes of asthma-related to the inflammatory endotype and the choice of biologic therapy.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

\> Group 1 \<

Inclusion Criteria:

* severe persistent eosinophilic AB (type 2- high)
* initiated biological treatment against IL-5 or IL-5R (mepolizumab, benralizumab) on this study visit
* judged by the treating physician, the patient cannot be indicated to treatment against anti IgE or anti IL-4R (omalizumab, dupilumab)
* signed informed consent
* signed consent to the processing of personal data
* willingness and ability to undergo examination

Exclusion Criteria:

* active smoker
* BMI higher than 40kg/m2
* ongoing oncological disease or oncological disease during the last 12 months
* severe cardiovascular disease
* uncontrolled diabetes mellitus
* contraindication of choosen biological treatment per SPC

  * Group 2 \<

Inclusion Criteria:

* severe persistent eosinophil AB (type 2- high)
* initiated biological treatment against IgE or IL-4R (omalizumab, dupilumab) at this study visit
* judged by the treating physician, a patient cannot be indicated to treatment against anti IL-5 or anti IL-5R (mepolizumab, benralizumab)
* signed informed consent
* signed consent to the processing of personal data
* willingness and ability to undergo examination

Exclusion Criteria:

* active smoker
* BMI higher than 40kg/m2
* ongoing oncological disease or oncological disease during the last 12 months
* severe cardiovascular disease
* uncontrolled diabetes mellitus
* contraindication of choosen biological treatment per SPC

  * Group 3 \<

Inclusion Criteria:

* severe persistent eosinophil AB (type 2- high)
* initiated biological treatment against IgE or IL-4R (omalizumab, dupilumab) or against IL-5 or IL-5R (mepolizumab, benralizumab) at this study visit was
* judged by the treating physician, the patient could be potentially indicated to treatment with all 4 alternatives
* signed informed consent
* signed consent to the processing of personal data
* willingness and ability to undergo examination

Exclusion Criteria:

* active smoker
* BMI higher than 40kg/m2
* ongoing oncological disease or oncological disease during the last 12 months
* severe cardiovascular disease
* uncontrolled diabetes mellitus
* contraindication of choosen biological treatment per SPC

  * Group 4 \<

Inclusion Criteria:

* severe persistent non-eosinophil AB (type 2- low)
* judged by the treating physician, the patient cannot be indicated for biological treatment
* signed informed consent
* signed consent to the processing of personal data
* willingness and ability to undergo examination

Exclusion Criteria:

* active smoker
* BMI higher than 40kg/m2
* ongoing oncological disease or oncological disease during the last 12 months
* severe cardiovascular disease
* uncontrolled diabetes mellitus

Locations (1)

Hradec Králové, Královehradecký Kraj, Czechia