Effects of Anti-IL5 Biological Treatments on Blood IgE Levels in Severe Asthmatic Patients
- Conditions
- Asthma; EosinophilicAsthma
- Interventions
- Diagnostic Test: Total IgEDiagnostic Test: Blood cell countsDiagnostic Test: Asthma control assessmentDiagnostic Test: lung function tests
- Registration Number
- NCT04181190
- Lead Sponsor
- Università degli Studi di Ferrara
- Brief 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.
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- 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)
- asthma exacerbation in last 8 weeks
- patients treated for COPD
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Mepolizumab group lung function tests atopic patients with severe eosinophilic asthma treated with anti-IL-5 monoclonal antibody (Mepolizumab) Mepolizumab group Blood cell counts atopic patients with severe eosinophilic asthma treated with anti-IL-5 monoclonal antibody (Mepolizumab) Benralizumab group Total IgE atopic patients with severe eosinophilic asthma treated with anti-IL5 receptor monoclonal antibody (Benralizumab) Benralizumab group Blood cell counts atopic patients with severe eosinophilic asthma treated with anti-IL5 receptor monoclonal antibody (Benralizumab) Mepolizumab group Total IgE atopic patients with severe eosinophilic asthma treated with anti-IL-5 monoclonal antibody (Mepolizumab) Mepolizumab group Asthma control assessment atopic patients with severe eosinophilic asthma treated with anti-IL-5 monoclonal antibody (Mepolizumab) Benralizumab group Asthma control assessment atopic patients with severe eosinophilic asthma treated with anti-IL5 receptor monoclonal antibody (Benralizumab) Benralizumab group lung function tests atopic patients with severe eosinophilic asthma treated with anti-IL5 receptor monoclonal antibody (Benralizumab)
- Primary Outcome Measures
Name Time Method IgE levels in mepolizumab group 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
- Secondary Outcome Measures
Name Time Method Total leucocytes in mepolizumab group 4±2 months 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
Eosinophils (number) in mepolizumab group 4±2 months 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
Eosinophils (%) in mepolizumab group 4±2 months 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
Basophils (number) in mepolizumab group 4±2 months 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
Basophils (%) in mepolizumab group 4±2 months 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
lymphocytes (number) in mepolizumab group 4±2 months 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
Lymphocytes (%) in mepolizumab group 4±2 months 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
IgE levels in Benralizumab group 4±2 months 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
Total leucocytes in Benralizumab group 4±2 months 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
Eosinophils (number) in Benralizumab group 4±2 months 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
Eosinophils (%) in Benralizumab group 4±2 months 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
Basophils (number) in Benralizumab group 4±2 months 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
Basophils (%) in Benralizumab group 4±2 months 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
Lymphocytes (number) in Benralizumab group 4±2 months 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
Lymphocites (%) in Benralizumab group 4±2 months 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
respiratory function (FEV1 - liter) in Mepolizumab group 4±2 months To evaluate FEV1 (liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab
respiratory function (FEV1 - %) in Mepolizumab group 4±2 months To evaluate FEV1 (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab
respiratory function (vital capacity - liter) in Mepolizumab group 4±2 months 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
respiratory function (vital capacity - %) in Mepolizumab group 4±2 months To evaluate VC (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab
respiratory function (forced vital capacity - liter) in Mepolizumab group 4±2 months 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
respiratory function (forced vital capacity - % predicted) in Mepolizumab group 4±2 months To evaluate FVC (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab
respiratory function (FEV1/FVC ratio) in Mepolizumab group 4±2 months 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.
respiratory function (FEV1/VC ratio) in Mepolizumab group 4±2 months 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
respiratory function (FEV1 - %) in Benralizumab group 4±2 months To evaluate FEV1 (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
respiratory function (FEV1 - lier) in Benralizumab group 4±2 months To evaluate FEV1 (liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
respiratory function (FVC - liter) in Benralizumab group 4±2 months To evaluate FVC (liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
respiratory function (FVC - %) in Benralizumab group 4±2 months To evaluate FVC (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
respiratory function (VC - liter) in Benralizumab group 4±2 months To evaluate VC (liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
respiratory function (VC - %) in Benralizumab group 4±2 months To evaluate VC (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
respiratory function (FEV1/FVC ratio) in Benralizumab group 4±2 months 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.
respiratory function (FEV1/VC ratio) in Benralizumab group 4±2 months 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
Fractional exhaled nitric oxigen (FeNO) in Mepozumab group 4±2 months To evaluate FeNO (ppb) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab
Fractional exhaled nitric oxigen (FeNO) in Benralizumab group 4±2 months To evaluate FeNO (ppb) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
Asthma control test in Mepolizumab group 4±2 months 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
Asthma control test in Benralizumab group 4±2 months 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
correlation between eosinophils and total IgE 4±2 months To evaluate the correlations (Pearson correlation coefficient) between the change in total eosinophil counts and IgE levels in patients treated with Mepolizumab or Benralizumab.
correlation between total IgE and lung function 4±2 months 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.
correlation between total IgE and asthma control 4±2 months 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.
Trial Locations
- Locations (8)
Azienda Ospedaliero Universitaria Ferrara
🇮🇹Ferrara, Italy
Professor of Respiratory Medicine Department of Medical and Surgical Sciences University of Foggia - Italy
🇮🇹Foggia, Italy
Malattie dell' Apparato Respiratorio Dipartimento di Scienza Mediche e Chirurgiche Materni-Infantili e dell'Adulto. Azienda Ospedaliero Universitaria di Modena
🇮🇹Modena, Italy
UOC Pneumologia Azienda Ospedaliera Univeristaria Integrata - Verona
🇮🇹Verona, Italy
UOC Pneumologia Ospedale L.Sacco - Polo Univestiario ASST Fatebenefratelli - Milano
🇮🇹Milan, 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