Status:
COMPLETED
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
Lead Sponsor:
Value Outcomes Ltd.
Collaborating Sponsors:
AstraZeneca
Conditions:
Asthma; Eosinophilic
Asthma Chronic
Eligibility:
All Genders
Brief Summary
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 desc...
Detailed Description
According to WHO, asthma bronchiale (AB) is the most frequent non-infectious disease in adults. There are 340 million patients with AB in the world. Approximately 500 000 patients in the Czech Republi...
Eligibility Criteria
Inclusion
- \> Group 1 \<
- 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
- 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
Key Trial Info
Start Date :
August 16 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT05270278
Start Date
August 16 2022
End Date
March 31 2023
Last Update
February 23 2024
Active Locations (1)
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1
Fakultní nemocnice Hradec Králové
Hradec Králové, Královehradecký Kraj, Czechia, 50005