AsthmaBIONIGENCT04181190
Effects of Anti-IL5 Biological Treatments on Blood IgE Levels in Severe Asthmatic Patients
An observational study of Asthma and Asthma; Eosinophilic, run by Università degli Studi di Ferrara at 8 sites in Italy.
Trial summary
Real-life, observational, retrospective, multicenter study to evaluate the effects of anti-IL5 biological treatments on blood total IgE Levels in atopic patients with severe eosinophilic asthma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma, Asthma; Eosinophilic
- What is being tested?
- Total IgE, Blood cell counts and lung function tests
- How many people
- 130 participants
- Where
- 8 sitesItaly
- Study dates
- 11 Oct 2019to 1 Nov 2020
- 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: atopic patients with severe eosinophilic asthma treated with anti IL-5 (Mepolizumab) or anti IL5-receptor (Benralizumab) humanized monoclonal antibodies
Who may be able to join
- atopy
- severe eosinophilic asthma (according to GINA guideline - available at https://ginasthma.org)
- patients treated with monoclonal antibody anti IL-5 (Mepolizumab) or with IL-5 anti-receptor monoclonal antibody (Benralizumab).
- stable asthma (free from asthma exacerbation for at least 8 weeks)
Who cannot join
- asthma exacerbation in last 8 weeks
- patients treated for COPD
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
Azienda Ospedaliero Universitaria Ferrara
Ferrara, 44124
Professor of Respiratory Medicine Department of Medical and Surgical Sciences University of Foggia - Italy
Foggia
UOC Pneumologia Ospedale L.Sacco - Polo Univestiario ASST Fatebenefratelli - Milano
Milan
Malattie dell' Apparato Respiratorio Dipartimento di Scienza Mediche e Chirurgiche Materni-Infantili e dell'Adulto. Azienda Ospedaliero Universitaria di Modena
Modena
AOUP Giaccone Palermo, dipartimento PROMISE, Università di Palermo
Palermo
S.C di Pneumologia Ospedale S. Maria degli Angeli AAS5 Friuli Occidentale
Pordenone
Department of Medical Specialties, Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL di Reggio Emilia-IRCCS
Reggio Emilia
UOC Pneumologia Azienda Ospedaliera Univeristaria Integrata - Verona
Verona
About this study
Official title: Effects of Anti-IL5 Biological Treatments of Total Blood IgE Levels in Severe Asthmatic Patients: Real-life Retrospective Multicenter Observational Study
Real-life, observational, retrospective, multicenter study to evaluate the effects of anti-IL5 biological treatments on blood total IgE Levels in atopic patients with severe eosinophilic asthma.
Read the detailed description
Severe asthma, i.e. asthma that is not controlled despite maximal optimized therapy and/or that worsens when high dose treatment is decreased (GINA guidelines - available at https://ginasthma.or), is a major unmet medical need. Major advances in the management of severe asthma occurred in the past few years due to the new targeted biological therapies. Mepolizumab and Benralizumab are humanized monoclonal antibodies able to block interleukin (IL)-5 and the receptor for IL-5, respectively. These biological treatments block the eosinophilic driven inflammation. The effects of these treatments on an other key effector molecule of the T2-immune response, i.e. IgE, is virtually unknown.
To explore this issue, we set up a real life, observational, retrospective, multicenter study. The study will enroll patients with severe eosinophilic asthma already treated with Mepolizumab or Benralizumab. The following variable will be collected before the the biological treatment and at 4±2 months after the initiation of the pharmacological regimen:
- demographic data
- age of onset of asthma
- smoking habit
- concomitant pharmacological regimens
- number of asthma exacerbations since last visit
- concomitant diseases (particularly gastroesophageal reflux, nasal polyposis, atopic dermatitis, obesity, anxiety-depressive syndrome).
- White Blood Cell Count and Differential (and in particular the levels of total leucocytes, lymphocytes, eosinophils and basophils)
- Lung function tests (spirometry)
- Conditions
- Asthma, Asthma; Eosinophilic
- Being tested
- Total IgE, Blood cell counts, Asthma control assessment, lung function tests
- Keywords
- IgE, Eosinophils, Mepolizumab, Benralizumab, Severe Asthma
- Medical subject headings
- Asthma, Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total IgEDiagnostic test
Levels of total IgE before biological treatments and at 4±2 months of treatments
Blood cell countsDiagnostic test
White Blood Cell Count and Differential (and in particular the levels of total leucocytes, lymphocytes, eosinophils and basophils)
Asthma control assessmentDiagnostic test
Levels of asthma control assessed by asthma control questionnaire (ACT) before initiation of biological treatments and at 4± months of treatments
lung function testsDiagnostic test
Lung function tests performed before initiation of biological treatments and at 4± months of treatments
| Study group | Role | What they receive |
|---|---|---|
| Mepolizumab group | atopic patients with severe eosinophilic asthma treated with anti-IL-5 monoclonal antibody (Mepolizumab) Receives: Diagnostic Test: Total IgE; Diagnostic Test: Blood cell counts; Diagnostic Test: Asthma control assessment; Diagnostic Test: lung function tests | |
| Benralizumab group | atopic patients with severe eosinophilic asthma treated with anti-IL5 receptor monoclonal antibody (Benralizumab) Receives: Diagnostic Test: Total IgE; Diagnostic Test: Blood cell counts; Diagnostic Test: Asthma control assessment; Diagnostic Test: lung function tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgE levels in mepolizumab group
To evaluate total IgE levels (kU/l) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months after initiation of anti-IL5 monoclonal antibody Mepolizumab
Measured: 4±2 months
Secondary outcomes (38)
Total leucocytes in mepolizumab group
To evaluate total leucocytes (number of cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with anti-IL5 monoclonal antibody Mepolizumab
Measured: 4±2 months
Eosinophils (number) in mepolizumab group
To evaluate the number of blood eosinophils (cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with anti-IL5 monoclonal antibody Mepolizumab
Measured: 4±2 months
Eosinophils (%) in mepolizumab group
To evaluate the percentage of blood eosinophils (%) total blood white cells in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with anti-IL5 monoclonal antibody Mepolizumab
Measured: 4±2 months
Basophils (number) in mepolizumab group
To evaluate the number of blood basophils (cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with anti-IL5 monoclonal antibody Mepolizumab
Measured: 4±2 months
Basophils (%) in mepolizumab group
To evaluate the percentage of blood basophils (%) to totale white blood cells in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with anti-IL5 monoclonal antibody Mepolizumab
Measured: 4±2 months
lymphocytes (number) in mepolizumab group
To evaluate the number of blood lymphocytes (cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with anti-IL5 monoclonal antibody Mepolizumab
Measured: 4±2 months
Lymphocytes (%) in mepolizumab group
To evaluate the percentage of blood lymphocytes (%) to total white cells in atopic patients with severe eosinophilic asthma at 4 ± 2 months from the start of treatment with anti-IL5 monoclonal antibody Mepolizumab
Measured: 4±2 months
IgE levels in Benralizumab group
To evaluate total IgE levels (kU/l) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benralizumab
Measured: 4±2 months
Total leucocytes in Benralizumab group
To evaluate total leucocytes (number of cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benralizumab compared to the pretreatment value
Measured: 4±2 months
Eosinophils (number) in Benralizumab group
To evaluate the number of blood eosinophils (cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benralizumab
Measured: 4±2 months
Eosinophils (%) in Benralizumab group
To evaluate the percentage of blood eosinophils (%) total blood white cells in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benralizumab
Measured: 4±2 months
Basophils (number) in Benralizumab group
To evaluate the number of blood basophils (cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benralizumab
Measured: 4±2 months
Basophils (%) in Benralizumab group
To evaluate the percentage of blood basophils (%) to totale white blood cells in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benralizumab
Measured: 4±2 months
Lymphocytes (number) in Benralizumab group
To evaluate the number of blood lymphocytes (cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benralizumab
Measured: 4±2 months
Lymphocites (%) in Benralizumab group
To evaluate the percentage of blood lymphocytes (%) to total white cells in atopic patients with severe eosinophilic asthma at 4 ± 2 months from the start of treatment with Benralizumab
Measured: 4±2 months
respiratory function (FEV1 - liter) in Mepolizumab group
To evaluate FEV1 (liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab
Measured: 4±2 months
respiratory function (FEV1 - %) in Mepolizumab group
To evaluate FEV1 (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab
Measured: 4±2 months
respiratory function (vital capacity - liter) in Mepolizumab group
To evaluate vital capacity (VC - liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab
Measured: 4±2 months
respiratory function (vital capacity - %) in Mepolizumab group
To evaluate VC (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab
Measured: 4±2 months
respiratory function (forced vital capacity - liter) in Mepolizumab group
To evaluate forced vital capacity (FVC - liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab
Measured: 4±2 months
respiratory function (forced vital capacity - % predicted) in Mepolizumab group
To evaluate FVC (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab
Measured: 4±2 months
respiratory function (FEV1/FVC ratio) in Mepolizumab group
To evaluate FEV1/FVC ratio in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab compared to the pretreatment value.
Measured: 4±2 months
respiratory function (FEV1/VC ratio) in Mepolizumab group
To evaluate FEV1/VC ratio in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab
Measured: 4±2 months
respiratory function (FEV1 - %) in Benralizumab group
To evaluate FEV1 (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
Measured: 4±2 months
respiratory function (FEV1 - lier) in Benralizumab group
To evaluate FEV1 (liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
Measured: 4±2 months
respiratory function (FVC - liter) in Benralizumab group
To evaluate FVC (liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
Measured: 4±2 months
respiratory function (FVC - %) in Benralizumab group
To evaluate FVC (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
Measured: 4±2 months
respiratory function (VC - liter) in Benralizumab group
To evaluate VC (liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
Measured: 4±2 months
respiratory function (VC - %) in Benralizumab group
To evaluate VC (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
Measured: 4±2 months
respiratory function (FEV1/FVC ratio) in Benralizumab group
To evaluate FEV1/VC ratio in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab compared to the pretreatment value.
Measured: 4±2 months
respiratory function (FEV1/VC ratio) in Benralizumab group
To evaluate FEV1/FVC ratio in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
Measured: 4±2 months
Fractional exhaled nitric oxigen (FeNO) in Mepozumab group
To evaluate FeNO (ppb) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab
Measured: 4±2 months
Fractional exhaled nitric oxigen (FeNO) in Benralizumab group
To evaluate FeNO (ppb) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
Measured: 4±2 months
Asthma control test in Mepolizumab group
To evaluate asthma control test (ACT) in patients with severe eosinophilic asthma at baseline and at baseline and at 4 ± 2 months from the start of Mepolizumab
Measured: 4±2 months
Asthma control test in Benralizumab group
To evaluate asthma control test (ACT) in patients with severe eosinophilic asthma at baseline and at baseline and at 4 ± 2 months from the start of Benralizumab
Measured: 4±2 months
correlation between eosinophils and total IgE
To evaluate the correlations (Pearson correlation coefficient) between the change in total eosinophil counts and IgE levels in patients treated with Mepolizumab or Benralizumab.
Measured: 4±2 months
correlation between total IgE and lung function
To evaluate the correlations (Pearson correlation coefficient) between the change in total IgE levels and in functional parameters (FEV1, FVC and VC) in patients treated with Mepolizumab or Benralizumab.
Measured: 4±2 months
correlation between total IgE and asthma control
To evaluate the correlations (Pearson correlation coefficient) between the change in total IgE levels and the change of asthma control (measured by asthma control test - ACT) in patients treated with Mepolizumab or Benralizumab.
Measured: 4±2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start11 Oct 2019
- Primary completion1 Oct 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Papi, MD, Università degli Studi di Ferrara
- Investigators
- Marco Contoli, Prof, Principal investigator, Università di Ferrara - Azienda Ospedaliero Universitaria di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181190
- Sponsor's protocol ID
- 272/2019/Oss/AOUFe BIONIGE
- Acronym
- BIONIGE
- Status last verified
- Nov 2020
- First submitted
- 15 Nov 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- 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 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anti-IL5 Biological Treatments of Total Blood IgE Levels in Severe Asthmatic Patients: Real-life Retrospective Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT04181190
- Acronym / sponsor ID
- BIONIGE / 272/2019/Oss/AOUFe BIONIGE
- Conditions
- Asthma, Asthma; Eosinophilic
- Keywords
- IgE, Eosinophils, Mepolizumab, Benralizumab, Severe Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 29 Nov 2019 (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.
Real-life, observational, retrospective, multicenter study to evaluate the effects of anti-IL5 biological treatments on blood total IgE Levels in atopic patients with severe eosinophilic asthma.
Detailed description
Severe asthma, i.e. asthma that is not controlled despite maximal optimized therapy and/or that worsens when high dose treatment is decreased (GINA guidelines - available at https://ginasthma.or), is a major unmet medical need. Major advances in the management of severe asthma occurred in the past few years due to the new targeted biological therapies. Mepolizumab and Benralizumab are humanized monoclonal antibodies able to block interleukin (IL)-5 and the receptor for IL-5, respectively. These biological treatments block the eosinophilic driven inflammation. The effects of these treatments on an other key effector molecule of the T2-immune response, i.e. IgE, is virtually unknown.
To explore this issue, we set up a real life, observational, retrospective, multicenter study. The study will enroll patients with severe eosinophilic asthma already treated with Mepolizumab or Benralizumab. The following variable will be collected before the the biological treatment and at 4±2 months after the initiation of the pharmacological regimen:
- demographic data
- age of onset of asthma
- smoking habit
- concomitant pharmacological regimens
- number of asthma exacerbations since last visit
- concomitant diseases (particularly gastroesophageal reflux, nasal polyposis, atopic dermatitis, obesity, anxiety-depressive syndrome).
- White Blood Cell Count and Differential (and in particular the levels of total leucocytes, lymphocytes, eosinophils and basophils)
- Lung function tests (spirometry)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mepolizumab group | – | Diagnostic Test: Total IgE, Diagnostic Test: Blood cell counts, Diagnostic Test: Asthma control assessment, Diagnostic Test: lung function testsatopic patients with severe eosinophilic asthma treated with anti-IL-5 monoclonal antibody (Mepolizumab) |
| Benralizumab group | – | Diagnostic Test: Total IgE, Diagnostic Test: Blood cell counts, Diagnostic Test: Asthma control assessment, Diagnostic Test: lung function testsatopic patients with severe eosinophilic asthma treated with anti-IL5 receptor monoclonal antibody (Benralizumab) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- atopic patients with severe eosinophilic asthma treated with anti IL-5 (Mepolizumab) or anti IL5-receptor (Benralizumab) humanized monoclonal antibodies
Key inclusion criteria (4 listed)
- atopy
- severe eosinophilic asthma (according to GINA guideline - available at https://ginasthma.org)
- patients treated with monoclonal antibody anti IL-5 (Mepolizumab) or with IL-5 anti-receptor monoclonal antibody (Benralizumab).
- stable asthma (free from asthma exacerbation for at least 8 weeks)
Key exclusion criteria (2 listed)
- asthma exacerbation in last 8 weeks
- patients treated for COPD
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 |
|---|---|---|
| Total IgELevels of total IgE before biological treatments and at 4±2 months of treatments | Diagnostic test | Benralizumab group, Mepolizumab group |
| Blood cell countsWhite Blood Cell Count and Differential (and in particular the levels of total leucocytes, lymphocytes, eosinophils and basophils) | Diagnostic test | Benralizumab group, Mepolizumab group |
| Asthma control assessmentLevels of asthma control assessed by asthma control questionnaire (ACT) before initiation of biological treatments and at 4± months of treatments | Diagnostic test | Benralizumab group, Mepolizumab group |
| lung function testsLung function tests performed before initiation of biological treatments and at 4± months of treatments | Diagnostic test | Benralizumab group, Mepolizumab group |
Primary outcome
IgE levels in mepolizumab group
Time frame: 4±2 months
To evaluate total IgE levels (kU/l) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months after initiation of anti-IL5 monoclonal antibody Mepolizumab
38 secondary outcomes
Total leucocytes in mepolizumab group
Time frame: 4±2 months
Eosinophils (number) in mepolizumab group
Time frame: 4±2 months
Eosinophils (%) in mepolizumab group
Time frame: 4±2 months
Basophils (number) in mepolizumab group
Time frame: 4±2 months
Basophils (%) in mepolizumab group
Time frame: 4±2 months
lymphocytes (number) in mepolizumab group
Time frame: 4±2 months
Lymphocytes (%) in mepolizumab group
Time frame: 4±2 months
IgE levels in Benralizumab group
Time frame: 4±2 months
Total leucocytes in Benralizumab group
Time frame: 4±2 months
Eosinophils (number) in Benralizumab group
Time frame: 4±2 months
Eosinophils (%) in Benralizumab group
Time frame: 4±2 months
Basophils (number) in Benralizumab group
Time frame: 4±2 months
Basophils (%) in Benralizumab group
Time frame: 4±2 months
Lymphocytes (number) in Benralizumab group
Time frame: 4±2 months
Lymphocites (%) in Benralizumab group
Time frame: 4±2 months
respiratory function (FEV1 - liter) in Mepolizumab group
Time frame: 4±2 months
respiratory function (FEV1 - %) in Mepolizumab group
Time frame: 4±2 months
respiratory function (vital capacity - liter) in Mepolizumab group
Time frame: 4±2 months
respiratory function (vital capacity - %) in Mepolizumab group
Time frame: 4±2 months
respiratory function (forced vital capacity - liter) in Mepolizumab group
Time frame: 4±2 months
respiratory function (forced vital capacity - % predicted) in Mepolizumab group
Time frame: 4±2 months
respiratory function (FEV1/FVC ratio) in Mepolizumab group
Time frame: 4±2 months
respiratory function (FEV1/VC ratio) in Mepolizumab group
Time frame: 4±2 months
respiratory function (FEV1 - %) in Benralizumab group
Time frame: 4±2 months
respiratory function (FEV1 - lier) in Benralizumab group
Time frame: 4±2 months
respiratory function (FVC - liter) in Benralizumab group
Time frame: 4±2 months
respiratory function (FVC - %) in Benralizumab group
Time frame: 4±2 months
respiratory function (VC - liter) in Benralizumab group
Time frame: 4±2 months
respiratory function (VC - %) in Benralizumab group
Time frame: 4±2 months
respiratory function (FEV1/FVC ratio) in Benralizumab group
Time frame: 4±2 months
respiratory function (FEV1/VC ratio) in Benralizumab group
Time frame: 4±2 months
Fractional exhaled nitric oxigen (FeNO) in Mepozumab group
Time frame: 4±2 months
Fractional exhaled nitric oxigen (FeNO) in Benralizumab group
Time frame: 4±2 months
Asthma control test in Mepolizumab group
Time frame: 4±2 months
Asthma control test in Benralizumab group
Time frame: 4±2 months
correlation between eosinophils and total IgE
Time frame: 4±2 months
correlation between total IgE and lung function
Time frame: 4±2 months
correlation between total IgE and asthma control
Time frame: 4±2 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 4 Nov 2020.
- 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.
Marco Contoli, Prof principal investigator
Università di Ferrara - Azienda Ospedaliero Universitaria di Ferrara
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Asthma; Eosinophilic, run by Università degli Studi di Ferrara at 8 sites in Italy.
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 4 inclusion and 2 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 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. 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?
IgE levels in mepolizumab group (time frame: 4±2 months). 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 4 Nov 2020.