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

NCT04181190 | Completed

• 1 other identifier: 272/2019/Oss/AOUFe BIONIGE
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 8

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.

Conditions

Asthma; Asthma; Eosinophilic

Keywords

IgE; Eosinophils; Mepolizumab; Benralizumab; Severe Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (38)

• Total leucocytes in mepolizumab group

  4±2 months

• Eosinophils (number) in mepolizumab group

  4±2 months

• Eosinophils (%) in mepolizumab group

  4±2 months

• Basophils (number) in mepolizumab group

  4±2 months

• Basophils (%) in mepolizumab group

  4±2 months

Study Arms (2)

Mepolizumab group

atopic patients with severe eosinophilic asthma treated with anti-IL-5 monoclonal antibody (Mepolizumab)

Diagnostic Test: Total IgE; Diagnostic Test: Blood cell counts; Diagnostic Test: Asthma control assessment; Diagnostic Test: lung function tests

Benralizumab group

atopic patients with severe eosinophilic asthma treated with anti-IL5 receptor monoclonal antibody (Benralizumab)

Diagnostic Test: Total IgE; Diagnostic Test: Blood cell counts; Diagnostic Test: Asthma control assessment; Diagnostic Test: lung function tests

Interventions

Total IgE DIAGNOSTIC_TEST

Levels of total IgE before biological treatments and at 4±2 months of treatments

Benralizumab group; Mepolizumab group

Blood cell counts DIAGNOSTIC_TEST

White Blood Cell Count and Differential (and in particular the levels of total leucocytes, lymphocytes, eosinophils and basophils)

Benralizumab group; Mepolizumab group

Asthma control assessment DIAGNOSTIC_TEST

Levels of asthma control assessed by asthma control questionnaire (ACT) before initiation of biological treatments and at 4± months of treatments

Benralizumab group; Mepolizumab group

lung function tests DIAGNOSTIC_TEST

Lung function tests performed before initiation of biological treatments and at 4± months of treatments

Benralizumab group; Mepolizumab group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• asthma exacerbation in last 8 weeks
• patients treated for COPD

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (8)

Azienda Ospedaliero Universitaria Ferrara

Ferrara, 44124, Italy

Location

Professor of Respiratory Medicine Department of Medical and Surgical Sciences University of Foggia - Italy

Foggia, Italy

Location

UOC Pneumologia Ospedale L.Sacco - Polo Univestiario ASST Fatebenefratelli - Milano

Milan, Italy

Location

Malattie dell' Apparato Respiratorio Dipartimento di Scienza Mediche e Chirurgiche Materni-Infantili e dell'Adulto. Azienda Ospedaliero Universitaria di Modena

Modena, Italy

Location

AOUP Giaccone Palermo, dipartimento PROMISE, Università di Palermo

Palermo, Italy

Location

S.C di Pneumologia Ospedale S. Maria degli Angeli AAS5 Friuli Occidentale

Pordenone, Italy

Location

Department of Medical Specialties, Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL di Reggio Emilia-IRCCS

Reggio Emilia, Italy

Location

UOC Pneumologia Azienda Ospedaliera Univeristaria Integrata - Verona

Verona, Italy

Location

MeSH Terms

Conditions

Asthma; Pulmonary Eosinophilia

Interventions

Blood Cell Count; Respiratory Function Tests

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Diagnostic Techniques, Respiratory System

Study Officials

• Marco Contoli, Prof

  Università di Ferrara - Azienda Ospedaliero Universitaria di Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Respiratory Unit

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 29, 2019
• Study Start: October 11, 2019
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

IT (8)