Ignite Creation Date:
2024-05-06 @ 2:00 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04181190
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2019-11-15
Brief Title:
Effects of Anti-IL5 Biological Treatments on Blood IgE Levels in Severe Asthmatic Patients
Sponsor:
Università degli Studi di Ferrara
Organization:
Università degli Studi di Ferrara
Study Overview
Official Title:
Effects of Anti-IL5 Biological Treatments of Total Blood IgE Levels in Severe Asthmatic Patients Real-life Retrospective Multicenter Observational Study
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIONIGE
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 ie asthma that is not controlled despite maximal optimized therapy andor that worsens when high dose treatment is decreased GINA guidelines - available at httpsginasthmaor 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 ie 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 42 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
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 42 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None