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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepolizumab group | atopic patients with severe eosinophilic asthma treated with anti-IL-5 monoclonal antibody (Mepolizumab) |
| |
| Benralizumab group | atopic patients with severe eosinophilic asthma treated with anti-IL5 receptor monoclonal antibody (Benralizumab) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total IgE | Diagnostic Test | Levels of total IgE before biological treatments and at 4±2 months of treatments |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4±2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4±2 months |
| Eosinophils (number) in mepolizumab group |
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Inclusion Criteria:
Exclusion Criteria:
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atopic patients with severe eosinophilic asthma treated with anti IL-5 (Mepolizumab) or anti IL5-receptor (Benralizumab) humanized monoclonal antibodies
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| Name | Affiliation | Role |
|---|---|---|
| Marco Contoli, Prof | Università di Ferrara - Azienda Ospedaliero Universitaria di Ferrara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Universitaria Ferrara | Ferrara | 44124 | Italy | |||
| Professor of Respiratory Medicine Department of Medical and Surgical Sciences University of Foggia - Italy |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D011657 | Pulmonary Eosinophilia |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D001772 | Blood Cell Count |
| D012129 | Respiratory Function Tests |
| ID | Term |
|---|---|
| D002452 | Cell Count |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Blood cell counts | Diagnostic Test | White Blood Cell Count and Differential (and in particular the levels of total leucocytes, lymphocytes, eosinophils and basophils) |
|
| Asthma control assessment | Diagnostic Test | Levels of asthma control assessed by asthma control questionnaire (ACT) before initiation of biological treatments and at 4± months of treatments |
|
| lung function tests | Diagnostic Test | Lung function tests performed before initiation of biological treatments and at 4± months of treatments |
|
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 |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 4±2 months |
| Foggia |
| Italy |
| UOC Pneumologia Ospedale L.Sacco - Polo Univestiario ASST Fatebenefratelli - Milano | Milan | Italy |
| Malattie dell' Apparato Respiratorio Dipartimento di Scienza Mediche e Chirurgiche Materni-Infantili e dell'Adulto. Azienda Ospedaliero Universitaria di Modena | Modena | Italy |
| AOUP Giaccone Palermo, dipartimento PROMISE, Università di Palermo | Palermo | Italy |
| S.C di Pneumologia Ospedale S. Maria degli Angeli AAS5 Friuli Occidentale | Pordenone | Italy |
| Department of Medical Specialties, Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL di Reggio Emilia-IRCCS | Reggio Emilia | Italy |
| UOC Pneumologia Azienda Ospedaliera Univeristaria Integrata - Verona | Verona | Italy |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D017681 | Hypereosinophilic Syndrome |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D003933 | Diagnosis |
| D006403 | Hematologic Tests |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D003948 | Diagnostic Techniques, Respiratory System |