Asthma; EosinophilicBASEASNCT04742504
Interaction Between Benralizumab and Basophils in Eosinophilic Asthma
An observational study of Asthma; Eosinophilic, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
In this study, investigators want to evaluation of the impact of benralizumab (Fasenra®, Astra Zeneca) on different cell populations, including basophils and innate lymphoid cells, and several biomarkers, such as miRNAs, cadena α dek receptor pra la interleukin % (IL5Rα) and soluble IL5Rα in patients with severe… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma; Eosinophilic
- What is being tested?
- BENRALIZUMAB
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 7 Sep 2021to 13 Oct 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Group A: f patients with severe eosinophilic uncontrolled asthma treated with Benralizumab Those will be patients with severe eosinophilic asthma who are being treated with benralizumab and who want to participate in a volunteer manner in the study after signing informed consent. The decision of the patients treatment with benralizumab included in the study will not come in any case influenced by their participation in the study but will be made in accordance with the clinical criteria established by the Asthma Multidisciplinary Unit (UMA). Group B:patients with allergic asthma without indication of treatment with biological therapy.
Who may be able to join
- .It is mandatory that all patients can comprehend the study requirements and provide informed consent for their participation in MEGA.
- Group A:
- Adult people (≥ 18 and ≤ 80 years old) with eosinophilic severe asthma requiring high-dose inhaled corticosteroids plus long-acting beta agonists (with or without long-acting muscarinic antagonist or Montelukast or oral corticosteroids)
- Benralizumab treatment approved.
- Group B:
- .Patients with allergic asthma (prick test or RAST positive).
Who cannot join
- Patients with continuous OCS treatment
- Patients with Immunosuppressive drugs
- Patients with primary or secondary immune deficiency,
- Patients with chronic or/and concomitant disease, presence of severe systemic disease or cancer,
- Patients with possible infestation by parasites.
- Patients with other acute or chronic active lung disorders Patients with significant psychiatric disorders
- Patients with biological treatment will be excludes for group B
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interaction Between Benralizumab and Basophils in Eosinophilic Asthma. Discovering a New Role of an Old Asthma Player: BASEAS STUDY (Basophils in Eosinophilic Asthma)
In this study, investigators want to evaluation of the impact of benralizumab (Fasenra®, Astra Zeneca) on different cell populations, including basophils and innate lymphoid cells, and several biomarkers, such as miRNAs, cadena α dek receptor pra la interleukin % (IL5Rα) and soluble IL5Rα in patients with severe eosinophilic asthma. For this, basophil and innate cells type 2 (ILC2) populations will be monitored in different point-time of treatment: 8 week (V1), 6 months (V2) and 1 year (V3) in blood and sputum samples. Also, follow-up IL5Rα expression on a cell surface of eosinophils, basophils and ILC2 from peripheral blood and sputum of patients treated with or or without benralizumab. Determination of IL5Rα levels will be performed by flow cytometry
Read the detailed description
For this:
- Investigators will monitor basophil miRNAs changes with benralizumab analyzing miRNAS profile of isolated basophil before and after benralizumab treatment.
- Also, in vitro characterization of benralizumab effects on functionality of human basophils (isolated from allergic asthmatic patients) and human cell line KU812, measuring apoptosis, activation, degranulation and histamine release will be performed.
- Conditions
- Asthma; Eosinophilic
- Being tested
- BENRALIZUMAB
- Keywords
- Asthma, Basophils, anti-receptor de interleukin 5, microRNAs, Benralizumab
- Medical subject headings
- Pulmonary Eosinophilia, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BENRALIZUMABBiological
The decision of the patients treatment with benralizumab (Fasenra®, Astra Zeneca) included in the study will not come in any case influenced by their participation in the study but will be made in accordance with the clinical criteria established by the Asthma Multidisciplinary Unit (UMA).
| Study group | Role | What they receive |
|---|---|---|
| BENRA Treated Patients | Patients with severe eosinophilic asthma who will be treated with benralizumab (Fasenra®, Astra Zeneca) will be able to participate in a volunteer manner in the study after sing informed consent. Receives: Biological: BENRALIZUMAB | |
| Non BENRA TREATED PATIENTSP | patients with controlled severe asthma requiring high-dose inhaled corticosteroids plus long-acting beta agonists (with or without oral corticosteroids) but without request of benralizumab (Fasenra®, Astra Zeneca) treatment will be recruited |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fold changes in number of basophils
Fold changes in number of basophils after 8 week, 6 months and 1 year of benralizumab treatment (Fasenra®, Astra Zeneca) in blood and sputum in patients with severe eosinophilic asthma
Measured: From 1 to 12 months
Fold changes in number of innate inmmune cells
Fold changes in number of innate immune cells s after 8 week, 6 months and 1 year of benralizumab treatment (Fasenra®, Astra Zeneca) in blood and sputum in patients with severe eosinophilic asthma
Measured: From 1 to 12 months
The fold changes of IL-5R expression in basophils
The fold changes of IL-5R expression in basophils after 8 week, 6 months and 1 year of benralizumab treatmen
Measured: From 1 to 12 months
The fold changes of f IL-5R expression in innate lymphoid cells
The fold changes of f IL-5R expression in innate lymphoid cells after 8 week, 6 months and 1 year of benralizumab treatment
Measured: From 1 to 12 months
Secondary outcomes (8)
Fold changes of miRNAs profile in basophils
- Fold changes of miRNAs profile in basophils after tratment of Benralizumab in in patients with severe eosinophilic asthma treatment.
Measured: From 6 to 18
Fold changes of serum IL-5R
Fold changes of serum IL-5R (microg/ml) in patients treated with benralizumab
Measured: Fromm 6 to 12
Effect of benralizumab in basophil apoptosis
The effect of benralizumab in basophil apoptosis isolated from from allergic asthmatic patients will be measure by fold change of annexin V
Measured: From 12 to 24 months
Effect of benralizumab in KU812 apoptosis
The effect of benralizumab in KU812 apoptosis will be measure by fold change of annexin V in KU812 cultures
Measured: From 12 to 24 months
Effect of benralizumab in basophil activation
The effect of benralizumab in basophil activation isolated from from allergic asthmatic patients will be measur by fold change of CD63, and CD203C on membrane by flow cytometry
Measured: From 12 to 24 months
Effect of benralizumab in KU812 activation
The effect of benralizumab in KU812 activation will be measurie by fold change of CD63, and CD203C on membrane by flow cytometry
Measured: From 12 to 24 months
Effect of benralizumab in basophil degranulation
The effect of benralizumab in basophil degranulation will be measure by histamine releasing in isolated basophils from from allergic asthmatic patients
Measured: From 12 to 24 months
Effect of benralizumab in KU812 degranulation
The effect of benralizumab in basophil degranulation will be measure by histamine releasing in KU812 cultured cells
Measured: From 12 to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start7 Sep 2021
- Primary completion1 Oct 2023
- Study completion13 Oct 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- VICTORIA DEL POZO, PhD, Principal investigator, IIS-FUNDACIÓN JIMENEZ DIAZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742504
- Sponsor's protocol ID
- ESR-20-20764
- Acronym
- BASEAS
- Status last verified
- Oct 2023
- First submitted
- 7 Jan 2021
- Last updated
- 17 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction Between Benralizumab and Basophils in Eosinophilic Asthma. Discovering a New Role of an Old Asthma Player: BASEAS STUDY (Basophils in Eosinophilic Asthma)
- ClinicalTrials.gov ID
- NCT04742504
- Acronym / sponsor ID
- BASEAS / ESR-20-20764
- Conditions
- Asthma; Eosinophilic
- Keywords
- Asthma, Basophils, anti-receptor de interleukin 5, microRNAs, Benralizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 8 Feb 2021 (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.
In this study, investigators want to evaluation of the impact of benralizumab (Fasenra®, Astra Zeneca) on different cell populations, including basophils and innate lymphoid cells, and several biomarkers, such as miRNAs, cadena α dek receptor pra la interleukin % (IL5Rα) and soluble IL5Rα in patients with severe eosinophilic asthma. For this, basophil and innate cells type 2 (ILC2) populations will be monitored in different point-time of treatment: 8 week (V1), 6 months (V2) and 1 year (V3) in blood and sputum samples. Also, follow-up IL5Rα expression on a cell surface of eosinophils, basophils and ILC2 from peripheral blood and sputum of patients treated with or or without benralizumab. Determination of IL5Rα levels will be performed by flow cytometry
Detailed description
For this:
- Investigators will monitor basophil miRNAs changes with benralizumab analyzing miRNAS profile of isolated basophil before and after benralizumab treatment.
- Also, in vitro characterization of benralizumab effects on functionality of human basophils (isolated from allergic asthmatic patients) and human cell line KU812, measuring apoptosis, activation, degranulation and histamine release will be performed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BENRA Treated Patients | – | Biological: BENRALIZUMABPatients with severe eosinophilic asthma who will be treated with benralizumab (Fasenra®, Astra Zeneca) will be able to participate in a volunteer manner in the study after sing informed consent. |
| Non BENRA TREATED PATIENTSP | – | –patients with controlled severe asthma requiring high-dose inhaled corticosteroids plus long-acting beta agonists (with or without oral corticosteroids) but without request of benralizumab (Fasenra®, Astra Zeneca) treatment will be recruited |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Group A: f patients with severe eosinophilic uncontrolled asthma treated with Benralizumab Those will be patients with severe eosinophilic asthma who are being treated with benralizumab and who want to participate in a volunteer manner in the study after signing informed consent. The decision of the patients treatment with benralizumab included in the study will not come in any case influenced by their participation in the study but will be made in accordance with the clinical criteria established by the Asthma Multidisciplinary Unit (UMA). Group B:patients with allergic asthma without indication of treatment with biological therapy.
Key inclusion criteria (6 listed)
- .It is mandatory that all patients can comprehend the study requirements and provide informed consent for their participation in MEGA.
- Adult people (≥ 18 and ≤ 80 years old) with eosinophilic severe asthma requiring high-dose inhaled corticosteroids plus long-acting beta agonists (with or without long-acting muscarinic antagonist or Montelukast or oral corticosteroids)
- Benralizumab treatment approved.
- .Patients with allergic asthma (prick test or RAST positive).
Key exclusion criteria (7 listed)
- Patients with continuous OCS treatment
- Patients with Immunosuppressive drugs
- Patients with primary or secondary immune deficiency,
- Patients with chronic or/and concomitant disease, presence of severe systemic disease or cancer,
- Patients with possible infestation by parasites.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BENRALIZUMABThe decision of the patients treatment with benralizumab (Fasenra®, Astra Zeneca) included in the study will not come in any case influenced by their participation in the study but will be made in accordance with the clinical criteria established by the Asthma Multidisciplinary Unit (UMA). | Biological | BENRA Treated Patients |
Primary outcome
Fold changes in number of basophils
Time frame: From 1 to 12 months
Fold changes in number of basophils after 8 week, 6 months and 1 year of benralizumab treatment (Fasenra®, Astra Zeneca) in blood and sputum in patients with severe eosinophilic asthma
Fold changes in number of innate inmmune cells
Time frame: From 1 to 12 months
Fold changes in number of innate immune cells s after 8 week, 6 months and 1 year of benralizumab treatment (Fasenra®, Astra Zeneca) in blood and sputum in patients with severe eosinophilic asthma
The fold changes of IL-5R expression in basophils
Time frame: From 1 to 12 months
The fold changes of IL-5R expression in basophils after 8 week, 6 months and 1 year of benralizumab treatmen
The fold changes of f IL-5R expression in innate lymphoid cells
Time frame: From 1 to 12 months
The fold changes of f IL-5R expression in innate lymphoid cells after 8 week, 6 months and 1 year of benralizumab treatment
8 secondary outcomes
Fold changes of miRNAs profile in basophils
Time frame: From 6 to 18
Fold changes of serum IL-5R
Time frame: Fromm 6 to 12
Effect of benralizumab in basophil apoptosis
Time frame: From 12 to 24 months
Effect of benralizumab in KU812 apoptosis
Time frame: From 12 to 24 months
Effect of benralizumab in basophil activation
Time frame: From 12 to 24 months
Effect of benralizumab in KU812 activation
Time frame: From 12 to 24 months
Effect of benralizumab in basophil degranulation
Time frame: From 12 to 24 months
Effect of benralizumab in KU812 degranulation
Time frame: From 12 to 24 months
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 17 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
VICTORIA DEL POZO, PhD principal investigator
IIS-FUNDACIÓN JIMENEZ DIAZ
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, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
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 6 inclusion and 7 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 17 Oct 2023. 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 Spain. 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?
Fold changes in number of basophils (time frame: From 1 to 12 months). The study lists 4 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 17 Oct 2023.