Asthma; EosinophilicNCT05270278
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
An observational study of Asthma; Eosinophilic and Asthma Chronic, run by Value Outcomes Ltd. at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma; Eosinophilic, Asthma Chronic, Bronchial Asthma
- How many people
- 89 participants
- Where
- 1 siteCzechia
- Study dates
- 16 Aug 2022to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients with severe AB type 2 - high (eosinophilic) and type 2- low (non-eosinophilic)
Who may be able to join
- 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
Show all 23Show fewer
- 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
- 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
- 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
Who cannot join
- 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
Show all 26Show fewer
- Group 2 <
- 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 <
- 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 <
- active smoker
- BMI higher than 40kg/m2
- ongoing oncological disease or oncological disease during the last 12 months
- severe cardiovascular disease
- uncontrolled diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Fakultní nemocnice Hradec Králové
Hradec Králové, Královehradecký Kraj, 50005
About this study
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.
Read the 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 Republic are suffering from AB and 2,1 % have severe AB with the indication for conventional anti-inflammatory treatment. This subgroup of patients represents significantly high costs for the healthcare system.
There are many clinical phenotypes and molecular endotypes of AB and each of these groups has a different response to treatment. In the Czech republic is recommended classification into two main groups: eosinophil AB (type 2- high) and non-eosinophil AB (type 2- low). Eosinophil AB is furthered classified into two groups: eosinophil allergic (Th2-high) and eosinophil non-allergic (ILC2-high).
New biologicals, indicated for patients with the most severe form of AB, have entered the market during the last 15 years. These biologicals have confirmed their potential in randomized controlled studies. It can be assumed that there are 4 000 - 5000 patients suffering from this type of AB who could be indicated to this treatment in the Czech republic but, unfortunately, only 10 % of them have the access to such therapies in real practice.
Recommended markers of type 2- high AB don´t have strictly set critical values that are often unspecific, unstable in time, and often affected by other diseases or treatments. Some of the widely accepted predictors of response to biological treatment are eosinophilia, allergic reactivity, level of total and allergic-specific IgE, NO production in inhaled air (FeNO), gender, number of previous exacerbations, and duration of disease. Some of these predictors are used as decision criteria also in Global Initiative for Asthma (GINA) guidelines.
With respect to these facts, enormous efforts are being made worldwide to search for new biomarkers, which would be reliable, valid, easily measurable, interpretable, and useful for a more accurate description of the pathogenetic processes of asthma
- 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
- Medical subject headings
- Pulmonary Eosinophilia, Asthma, Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory parameters (peripheral blood) - blood count
Measured: Baseline
Laboratory parameters (peripheral blood) - atopy
Measured: Baseline
Laboratory parameters (peripheral blood) - rheumatology
ANF, ENA, RF, ANCA (if not in the last 12 months)
Measured: Baseline
Laboratory parameters (peripheral blood) - immunology
IgE, ECP, IgG, IgA, IgM, classes IgG
Measured: Baseline
Laboratory parameters (peripheral blood) - flow cytometry (FACS)
The evaluation of eosinophil surface charakteristics per MFI
Measured: Baseline
Clinical parameters (exhaled air) - FeNO
Measured: Baseline
Clinical parameters (exhaled air) - alveolar NO
Measured: Baseline
Clinical parameters (exhaled air) - eNOSE
The examination with "the electronical nose"
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start16 Aug 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma; EosinophilicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Value Outcomes Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Jakub Novosad, MUDr.,Ph.D., Principal investigator, Fakultní nemocnice Hradec Králové
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270278
- Sponsor's protocol ID
- eNOSE
- Other IDs
- D3250L00044
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05270278
- Acronym / sponsor ID
- eNOSE
- Keywords
- airway inflammation, airway obstruction, airway disease, serious asthma, pulmonary, biological therapy, omalizumab, dupilumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Value Outcomes Ltd.University, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Republic are suffering from AB and 2,1 % have severe AB with the indication for conventional anti-inflammatory treatment. This subgroup of patients represents significantly high costs for the healthcare system.
There are many clinical phenotypes and molecular endotypes of AB and each of these groups has a different response to treatment. In the Czech republic is recommended classification into two main groups: eosinophil AB (type 2- high) and non-eosinophil AB (type 2- low). Eosinophil AB is furthered classified into two groups: eosinophil allergic (Th2-high) and eosinophil non-allergic (ILC2-high).
New biologicals, indicated for patients with the most severe form of AB, have entered the market during the last 15 years. These biologicals have confirmed their potential in randomized controlled studies. It can be assumed that there are 4 000 - 5000 patients suffering from this type of AB who could be indicated to this treatment in the Czech republic but, unfortunately, only 10 % of them have the access to such therapies in real practice.
Recommended markers of type 2- high AB don´t have strictly set critical values that are often unspecific, unstable in time, and often affected by other diseases or treatments. Some of the widely accepted predictors of response to biological treatment are eosinophilia, allergic reactivity, level of total and allergic-specific IgE, NO production in inhaled air (FeNO), gender, number of previous exacerbations, and duration of disease. Some of these predictors are used as decision criteria also in Global Initiative for Asthma (GINA) guidelines.
With respect to these facts, enormous efforts are being made worldwide to search for new biomarkers, which would be reliable, valid, easily measurable, interpretable, and useful for a more accurate description of the pathogenetic processes of asthma
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients with severe AB type 2 - high (eosinophilic) and type 2- low (non-eosinophilic)
Key inclusion criteria (23 listed)
- 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
Key exclusion criteria (26 listed)
- active smoker
- BMI higher than 40kg/m2
- ongoing oncological disease or oncological disease during the last 12 months
- severe cardiovascular disease
- uncontrolled diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Laboratory parameters (peripheral blood) - blood count
Time frame: Baseline
Laboratory parameters (peripheral blood) - atopy
Time frame: Baseline
Laboratory parameters (peripheral blood) - rheumatology
Time frame: Baseline
ANF, ENA, RF, ANCA (if not in the last 12 months)
Laboratory parameters (peripheral blood) - immunology
Time frame: Baseline
IgE, ECP, IgG, IgA, IgM, classes IgG
Laboratory parameters (peripheral blood) - flow cytometry (FACS)
Time frame: Baseline
The evaluation of eosinophil surface charakteristics per MFI
Clinical parameters (exhaled air) - FeNO
Time frame: Baseline
Clinical parameters (exhaled air) - alveolar NO
Time frame: Baseline
Clinical parameters (exhaled air) - eNOSE
Time frame: Baseline
The examination with "the electronical nose"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakub Novosad, MUDr.,Ph.D. principal investigator
Fakultní nemocnice Hradec Králové
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma; Eosinophilic and Asthma Chronic, run by Value Outcomes Ltd. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory parameters (peripheral blood) - blood count (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.