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 | Completed DMC

• 2 other identifiers: eNOSED3250L00044
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

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 description of the pathogenetic processes of asthma-related to the inflammatory endotype and the choice of biologic therapy.

Conditions

Asthma; Eosinophilic; Asthma Chronic; Bronchial Asthma; Asthma, Bronchial

Keywords

airway inflammation; airway obstruction; airway disease; serious asthma; pulmonary; biological therapy; omalizumab; dupilumab; mepolizumab; benralizumab; biomarkers; Exhaled Nitric Oxide Levels (FeNO); alveolar NO; cross-sectional study; exploratory analysis; conservative treatment

Outcome Measures

Primary Outcomes (8)

• Laboratory parameters (peripheral blood) - blood count

  Baseline

• Laboratory parameters (peripheral blood) - atopy

  Baseline

• Laboratory parameters (peripheral blood) - rheumatology

  ANF, ENA, RF, ANCA (if not in the last 12 months)

  Baseline

• Laboratory parameters (peripheral blood) - immunology

  IgE, ECP, IgG, IgA, IgM, classes IgG

  Baseline

• Laboratory parameters (peripheral blood) - flow cytometry (FACS)

  The evaluation of eosinophil surface charakteristics per MFI

  Baseline

• Clinical parameters (exhaled air) - FeNO

  Baseline

• Clinical parameters (exhaled air) - alveolar NO

  Baseline

• Clinical parameters (exhaled air) - eNOSE

  The examination with "the electronical nose"

  Baseline

Study Arms (4)

1. Eosinophilic AB - initiated biological treatment against IL-5 or IL-5R

* initiated biological treatment - mepolizumab or benralizumab * judged by the treating physician, the patient cannot indicated treatment of type anti IgE or anti IL-4R

2. Eosinophilic AB - initiated biological treatment against IgE or IL-4R

* initiated biological treatment - omalizumab or dupilumab * judged by the treating physician, patient cannot indicated treatment type anti IL-5 or anti IL-5R

3. Eosinophilic AB - initiated biological treatment against IgE or IL-4R, or against IL-5 or IL-5R

* initiated biological treatment - omalizumab or dupilumab, or mepolizumab or benralizumab * judged by the treating physician, the patient could be potentially indicated to treatment with all 4 alternatives

4. Non-eosinophilic AB - without indication for biological treatment

* no biological treatment initiated * judged by the treating physician, the patient cannot be indicated to biological treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients with severe AB type 2 - high (eosinophilic) and type 2- low (non-eosinophilic)

You may qualify if:

• 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

You may not qualify if:

• 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 \<
• 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
• active smoker
• BMI higher than 40kg/m2

Sponsors & Collaborators

• Value Outcomes Ltd.: lead
• AstraZeneca: collaborator

Study Sites (1)

Fakultní nemocnice Hradec Králové

Hradec Králové, Královehradecký Kraj, 50005, Czechia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

peripheral blood for evaluation of laboratory parameters

MeSH Terms

Conditions

Pulmonary Eosinophilia; Asthma; Airway Obstruction

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Insufficiency; Respiration Disorders

Study Officials

• Jakub Novosad, MUDr.,Ph.D.

  Fakultní nemocnice Hradec Králové

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 8, 2022
• Study Start: August 16, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

CZ (1)