Effects of Anti-IL5 Biological Treatments on Blood IgE Levels in Severe Asthmatic Patients

Asthma Clinical Trial

— BIONIGE  

Official title:

Effects of Anti-IL5 Biological Treatments of Total Blood IgE Levels in Severe Asthmatic Patients: Real-life Retrospective Multicenter Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04181190
• Other study ID #: 272/2019/Oss/AOUFe BIONIGE
• Status: Completed
• Start date: October 11, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: November 2020
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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 information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: November 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• asthma exacerbation in last 8 weeks

• patients treated for COPD

Related Conditions & MeSH terms

• Asthma
• Asthma; Eosinophilic
• Pulmonary Eosinophilia

Intervention

Diagnostic Test:
• Total IgE
Levels of total IgE before biological treatments and at 4±2 months of treatments
• Blood cell counts
White Blood Cell Count and Differential (and in particular the levels of total leucocytes, lymphocytes, eosinophils and basophils)
• Asthma control assessment
Levels of asthma control assessed by asthma control questionnaire (ACT) before initiation of biological treatments and at 4± months of treatments
• lung function tests
Lung function tests performed before initiation of biological treatments and at 4± months of treatments

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Ferrara	Ferrara
Italy	Professor of Respiratory Medicine Department of Medical and Surgical Sciences University of Foggia - Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

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