NCT04181190

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 130 (actual)
• Sponsor: Università degli Studi di Ferrara · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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)

Conditions

• Asthma
• Asthma; Eosinophilic

Interventions

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

Timeline

• Start date: 2019-10-11
• Primary completion: 2020-10-01
• Completion: 2020-11-01
• First posted: 2019-11-29
• Last updated: 2020-11-04

Locations

8 sites across 1 country: Italy