Clinical trial NCT04181190: Effects of Anti-IL5 Biological Treatments on Blood IgE Levels in Severe Asthmatic Patients
Official title: Effects of Anti-IL5 Biological Treatments of Total Blood IgE Levels in Severe Asthmatic Patients: Real-life Retrospective Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Asthma; Eosinophilic
Keywords: IgE
Eosinophils
Mepolizumab
Benralizumab
Severe Asthma
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2019-11-29
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: atopic patients with severe eosinophilic asthma treated with anti IL-5 (Mepolizumab) or anti IL5-receptor (Benralizumab) humanized monoclonal antibodies

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)

Eligibility criteria: 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

Primary outcomes:
measure: IgE levels in mepolizumab group
timeFrame: 4±2 months
Secondary outcomes:
measure: Total leucocytes in mepolizumab group
timeFrame: 4±2 months
measure: Eosinophils (number) in mepolizumab group
timeFrame: 4±2 months
measure: Eosinophils (%) in mepolizumab group
timeFrame: 4±2 months
measure: Basophils (number) in mepolizumab group
timeFrame: 4±2 months
measure: Basophils (%) in mepolizumab group
timeFrame: 4±2 months
measure: lymphocytes (number) in mepolizumab group
timeFrame: 4±2 months
measure: Lymphocytes (%) in mepolizumab group
timeFrame: 4±2 months
measure: IgE levels in Benralizumab group
timeFrame: 4±2 months
measure: Total leucocytes in Benralizumab group
timeFrame: 4±2 months
measure: Eosinophils (number) in Benralizumab group
timeFrame: 4±2 months
measure: Eosinophils (%) in Benralizumab group
timeFrame: 4±2 months
measure: Basophils (number) in Benralizumab group
timeFrame: 4±2 months
measure: Basophils (%) in Benralizumab group
timeFrame: 4±2 months
measure: Lymphocytes (number) in Benralizumab group
timeFrame: 4±2 months
measure: Lymphocites (%) in Benralizumab group
timeFrame: 4±2 months
measure: respiratory function (FEV1 - liter) in Mepolizumab group
timeFrame: 4±2 months
measure: respiratory function (FEV1 - %) in Mepolizumab group
timeFrame: 4±2 months
measure: respiratory function (vital capacity - liter) in Mepolizumab group
timeFrame: 4±2 months
measure: respiratory function (vital capacity - %) in Mepolizumab group
timeFrame: 4±2 months
measure: respiratory function (forced vital capacity - liter) in Mepolizumab group
timeFrame: 4±2 months
measure: respiratory function (forced vital capacity - % predicted) in Mepolizumab group
timeFrame: 4±2 months
measure: respiratory function (FEV1/FVC ratio) in Mepolizumab group
timeFrame: 4±2 months
measure: respiratory function (FEV1/VC ratio) in Mepolizumab group
timeFrame: 4±2 months
measure: respiratory function (FEV1 - %) in Benralizumab group
timeFrame: 4±2 months
measure: respiratory function (FEV1 - lier) in Benralizumab group
timeFrame: 4±2 months
measure: respiratory function (FVC - liter) in Benralizumab group
timeFrame: 4±2 months
measure: respiratory function (FVC - %) in Benralizumab group
timeFrame: 4±2 months
measure: respiratory function (VC - liter) in Benralizumab group
timeFrame: 4±2 months
measure: respiratory function (VC - %) in Benralizumab group
timeFrame: 4±2 months
measure: respiratory function (FEV1/FVC ratio) in Benralizumab group
timeFrame: 4±2 months
measure: respiratory function (FEV1/VC ratio) in Benralizumab group
timeFrame: 4±2 months
measure: Fractional exhaled nitric oxigen (FeNO) in Mepozumab group
timeFrame: 4±2 months
measure: Fractional exhaled nitric oxigen (FeNO) in Benralizumab group
timeFrame: 4±2 months
measure: Asthma control test in Mepolizumab group
timeFrame: 4±2 months
measure: Asthma control test in Benralizumab group
timeFrame: 4±2 months
measure: correlation between eosinophils and total IgE
timeFrame: 4±2 months
measure: correlation between total IgE and lung function
timeFrame: 4±2 months
measure: correlation between total IgE and asthma control
timeFrame: 4±2 months
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Azienda Ospedaliero Universitaria Ferrara
city: Foggia
country: Italy
facility: Professor of Respiratory Medicine Department of Medical and Surgical Sciences University of Foggia - Italy
city: Milan
country: Italy
facility: UOC Pneumologia Ospedale L.Sacco - Polo Univestiario ASST Fatebenefratelli - Milano
city: Modena
country: Italy
facility: Malattie dell' Apparato Respiratorio Dipartimento di Scienza Mediche e Chirurgiche Materni-Infantili e dell'Adulto. Azienda Ospedaliero Universitaria di Modena
city: Palermo
country: Italy
facility: AOUP Giaccone Palermo, dipartimento PROMISE, Università di Palermo
city: Pordenone
country: Italy
facility: S.C di Pneumologia Ospedale S. Maria degli Angeli AAS5 Friuli Occidentale
city: Reggio Emilia
country: Italy
facility: Department of Medical Specialties, Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL di Reggio Emilia-IRCCS
city: Verona
country: Italy
facility: UOC Pneumologia Azienda Ospedaliera Univeristaria Integrata - Verona
Study officials:
affiliation: Università di Ferrara - Azienda Ospedaliero Universitaria di Ferrara
name: Marco Contoli, Prof
role: PRINCIPAL_INVESTIGATOR
References: