Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
4±2 months |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|