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

Università degli Studi di Ferrara

Status

Completed

Conditions

Asthma

Asthma; Eosinophilic

Treatments

Diagnostic Test: lung function tests

Diagnostic Test: Asthma control assessment

Diagnostic Test: Total IgE

Diagnostic Test: Blood cell counts

Study type

Observational

Funder types

Other

Identifiers

NCT04181190

272/2019/Oss/AOUFe BIONIGE

Details and patient eligibility

About

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.

Full 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)

Enrollment

130 patients

Sex

All

Volunteers

No Healthy Volunteers

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