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NCT Number: NCT04181190

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero Universitaria Ferrara, Ferrara, Italy

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total IgE

Diagnostic Test

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

Blood cell counts

Diagnostic Test

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

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

Lung Function tests

Diagnostic Test

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

Primary outcomes

  1. IgE levels in mepolizumab group

    Time frame: 4±2 months

    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

Secondary outcomes

  1. Total leucocytes in mepolizumab group

    Time frame: 4±2 months

    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

  2. Eosinophils (number) in mepolizumab group

    Time frame: 4±2 months

    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

  3. Eosinophils (%) in mepolizumab group

    Time frame: 4±2 months

    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. Basophils (number) in mepolizumab group

    Time frame: 4±2 months

    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

  5. Basophils (%) in mepolizumab group

    Time frame: 4±2 months

    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

  6. lymphocytes (number) in mepolizumab group

    Time frame: 4±2 months

    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

  7. Lymphocytes (%) in mepolizumab group

    Time frame: 4±2 months

    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

  8. IgE levels in Benralizumab group

    Time frame: 4±2 months

    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

  9. Total leucocytes in Benralizumab group

    Time frame: 4±2 months

    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

  10. Eosinophils (number) in Benralizumab group

    Time frame: 4±2 months

    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

  11. Eosinophils (%) in Benralizumab group

    Time frame: 4±2 months

    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

  12. Basophils (number) in Benralizumab group

    Time frame: 4±2 months

    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

  13. Basophils (%) in Benralizumab group

    Time frame: 4±2 months

    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

  14. Lymphocytes (number) in Benralizumab group

    Time frame: 4±2 months

    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

  15. Lymphocites (%) in Benralizumab group

    Time frame: 4±2 months

    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

  16. respiratory function (FEV1 - liter) in Mepolizumab group

    Time frame: 4±2 months

    To evaluate FEV1 (liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab

  17. respiratory function (FEV1 - %) in Mepolizumab group

    Time frame: 4±2 months

    To evaluate FEV1 (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab

  18. respiratory function (vital capacity - liter) in Mepolizumab group

    Time frame: 4±2 months

    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

  19. respiratory function (vital capacity - %) in Mepolizumab group

    Time frame: 4±2 months

    To evaluate VC (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab

  20. respiratory function (forced vital capacity - liter) in Mepolizumab group

    Time frame: 4±2 months

    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

  21. respiratory function (forced vital capacity - % predicted) in Mepolizumab group

    Time frame: 4±2 months

    To evaluate FVC (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab

  22. respiratory function (FEV1/FVC ratio) in Mepolizumab group

    Time frame: 4±2 months

    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.

  23. respiratory function (FEV1/VC ratio) in Mepolizumab group

    Time frame: 4±2 months

    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

  24. respiratory function (FEV1 - %) in Benralizumab group

    Time frame: 4±2 months

    To evaluate FEV1 (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab

  25. respiratory function (FEV1 - lier) in Benralizumab group

    Time frame: 4±2 months

    To evaluate FEV1 (liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab

  26. respiratory function (FVC - liter) in Benralizumab group

    Time frame: 4±2 months

    To evaluate FVC (liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab

  27. respiratory function (FVC - %) in Benralizumab group

    Time frame: 4±2 months

    To evaluate FVC (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab

  28. respiratory function (VC - liter) in Benralizumab group

    Time frame: 4±2 months

    To evaluate VC (liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab

  29. respiratory function (VC - %) in Benralizumab group

    Time frame: 4±2 months

    To evaluate VC (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab

  30. respiratory function (FEV1/FVC ratio) in Benralizumab group

    Time frame: 4±2 months

    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.

  31. respiratory function (FEV1/VC ratio) in Benralizumab group

    Time frame: 4±2 months

    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

  32. Fractional exhaled nitric oxigen (FeNO) in Mepozumab group

    Time frame: 4±2 months

    To evaluate FeNO (ppb) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab

  33. Fractional exhaled nitric oxigen (FeNO) in Benralizumab group

    Time frame: 4±2 months

    To evaluate FeNO (ppb) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab

  34. Asthma control test in Mepolizumab group

    Time frame: 4±2 months

    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

  35. Asthma control test in Benralizumab group

    Time frame: 4±2 months

    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

  36. correlation between eosinophils and total IgE

    Time frame: 4±2 months

    To evaluate the correlations (Pearson correlation coefficient) between the change in total eosinophil counts and IgE levels in patients treated with Mepolizumab or Benralizumab.

  37. correlation between total IgE and lung function

    Time frame: 4±2 months

    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.

  38. correlation between total IgE and asthma control

    Time frame: 4±2 months

    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.

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Registry information

Official study title

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

Acronym: BIONIGE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 29, 2019
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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