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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04181190
Other study ID # 272/2019/Oss/AOUFe BIONIGE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 11, 2019
Est. completion date November 1, 2020

Study information

Verified date November 2020
Source Università degli Studi di Ferrara
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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)


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date November 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Italy Azienda Ospedaliero Universitaria Ferrara Ferrara
Italy Professor of Respiratory Medicine Department of Medical and Surgical Sciences University of Foggia - Italy Foggia
Italy UOC Pneumologia Ospedale L.Sacco - Polo Univestiario ASST Fatebenefratelli - Milano Milan
Italy Malattie dell' Apparato Respiratorio Dipartimento di Scienza Mediche e Chirurgiche Materni-Infantili e dell'Adulto. Azienda Ospedaliero Universitaria di Modena Modena
Italy AOUP Giaccone Palermo, dipartimento PROMISE, Università di Palermo Palermo
Italy S.C di Pneumologia Ospedale S. Maria degli Angeli AAS5 Friuli Occidentale Pordenone
Italy Department of Medical Specialties, Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL di Reggio Emilia-IRCCS Reggio Emilia
Italy UOC Pneumologia Azienda Ospedaliera Univeristaria Integrata - Verona Verona

Sponsors (1)

Lead Sponsor Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Total leucocytes in mepolizumab group To evaluate total leucocytes (number of cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with anti-IL5 monoclonal antibody Mepolizumab 4±2 months
Secondary Eosinophils (number) in mepolizumab group To evaluate the number of blood eosinophils (cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with anti-IL5 monoclonal antibody Mepolizumab 4±2 months
Secondary Eosinophils (%) in mepolizumab group To evaluate the percentage of blood eosinophils (%) total blood white cells in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with anti-IL5 monoclonal antibody Mepolizumab 4±2 months
Secondary Basophils (number) in mepolizumab group To evaluate the number of blood basophils (cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with anti-IL5 monoclonal antibody Mepolizumab 4±2 months
Secondary Basophils (%) in mepolizumab group To evaluate the percentage of blood basophils (%) to totale white blood cells in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with anti-IL5 monoclonal antibody Mepolizumab 4±2 months
Secondary lymphocytes (number) in mepolizumab group To evaluate the number of blood lymphocytes (cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with anti-IL5 monoclonal antibody Mepolizumab 4±2 months
Secondary Lymphocytes (%) in mepolizumab group To evaluate the percentage of blood lymphocytes (%) to total white cells in atopic patients with severe eosinophilic asthma at 4 ± 2 months from the start of treatment with anti-IL5 monoclonal antibody Mepolizumab 4±2 months
Secondary IgE levels in Benralizumab group To evaluate total IgE levels (kU/l) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benralizumab 4±2 months
Secondary Total leucocytes in Benralizumab group To evaluate total leucocytes (number of cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benralizumab compared to the pretreatment value 4±2 months
Secondary Eosinophils (number) in Benralizumab group To evaluate the number of blood eosinophils (cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benralizumab 4±2 months
Secondary Eosinophils (%) in Benralizumab group To evaluate the percentage of blood eosinophils (%) total blood white cells in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benralizumab 4±2 months
Secondary Basophils (number) in Benralizumab group To evaluate the number of blood basophils (cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benralizumab 4±2 months
Secondary Basophils (%) in Benralizumab group To evaluate the percentage of blood basophils (%) to totale white blood cells in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benralizumab 4±2 months
Secondary Lymphocytes (number) in Benralizumab group To evaluate the number of blood lymphocytes (cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benralizumab 4±2 months
Secondary Lymphocites (%) in Benralizumab group To evaluate the percentage of blood lymphocytes (%) to total white cells in atopic patients with severe eosinophilic asthma at 4 ± 2 months from the start of treatment with Benralizumab 4±2 months
Secondary respiratory function (FEV1 - liter) in Mepolizumab group To evaluate FEV1 (liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab 4±2 months
Secondary respiratory function (FEV1 - %) in Mepolizumab group To evaluate FEV1 (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab 4±2 months
Secondary respiratory function (vital capacity - liter) in Mepolizumab group To evaluate vital capacity (VC - liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab 4±2 months
Secondary respiratory function (vital capacity - %) in Mepolizumab group To evaluate VC (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab 4±2 months
Secondary respiratory function (forced vital capacity - liter) in Mepolizumab group To evaluate forced vital capacity (FVC - liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab 4±2 months
Secondary respiratory function (forced vital capacity - % predicted) in Mepolizumab group To evaluate FVC (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab 4±2 months
Secondary respiratory function (FEV1/FVC ratio) in Mepolizumab group To evaluate FEV1/FVC ratio in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab compared to the pretreatment value. 4±2 months
Secondary respiratory function (FEV1/VC ratio) in Mepolizumab group To evaluate FEV1/VC ratio in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab 4±2 months
Secondary respiratory function (FEV1 - %) in Benralizumab group To evaluate FEV1 (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab 4±2 months
Secondary respiratory function (FEV1 - lier) in Benralizumab group To evaluate FEV1 (liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab 4±2 months
Secondary respiratory function (FVC - liter) in Benralizumab group To evaluate FVC (liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab 4±2 months
Secondary respiratory function (FVC - %) in Benralizumab group To evaluate FVC (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab 4±2 months
Secondary respiratory function (VC - liter) in Benralizumab group To evaluate VC (liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab 4±2 months
Secondary respiratory function (VC - %) in Benralizumab group To evaluate VC (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab 4±2 months
Secondary respiratory function (FEV1/FVC ratio) in Benralizumab group To evaluate FEV1/VC ratio in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab compared to the pretreatment value. 4±2 months
Secondary respiratory function (FEV1/VC ratio) in Benralizumab group To evaluate FEV1/FVC ratio in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab 4±2 months
Secondary Fractional exhaled nitric oxigen (FeNO) in Mepozumab group To evaluate FeNO (ppb) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab 4±2 months
Secondary Fractional exhaled nitric oxigen (FeNO) in Benralizumab group To evaluate FeNO (ppb) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab 4±2 months
Secondary Asthma control test in Mepolizumab group To evaluate asthma control test (ACT) in patients with severe eosinophilic asthma at baseline and at baseline and at 4 ± 2 months from the start of Mepolizumab 4±2 months
Secondary Asthma control test in Benralizumab group To evaluate asthma control test (ACT) in patients with severe eosinophilic asthma at baseline and at baseline and at 4 ± 2 months from the start of Benralizumab 4±2 months
Secondary correlation between eosinophils and total IgE To evaluate the correlations (Pearson correlation coefficient) between the change in total eosinophil counts and IgE levels in patients treated with Mepolizumab or Benralizumab. 4±2 months
Secondary correlation between total IgE and lung function To evaluate the correlations (Pearson correlation coefficient) between the change in total IgE levels and in functional parameters (FEV1, FVC and VC) in patients treated with Mepolizumab or Benralizumab. 4±2 months
Secondary correlation between total IgE and asthma control To evaluate the correlations (Pearson correlation coefficient) between the change in total IgE levels and the change of asthma control (measured by asthma control test - ACT) in patients treated with Mepolizumab or Benralizumab. 4±2 months
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