BIOmarkers in Severe AsthMa Patients on Omalizumab Treatment

Study Overview
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Brief Summary
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Eosinophil infiltration and degranulation in airways has been implicated in the pathology of asthma. Periostin is considered to be a marker of eosinophilic inflammation and is one of the highly expressed genes in epithelial cells and lung fibroblasts in asthma. Omalizumab is approved as add-on therapy in the treatment of severe allergic asthma. The aim of the study is to assess inflammatory biomarkers including: blood and sputum eosinophilia, periostin and IL-6 as long-term clinical outcomes of omalizumab therapy.

Detailed Description
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Anti-IgE (omalizumab) has been shown to be an effective add-on therapy for patients with allergic severe asthma. In this observational study patients aged over 18 year with uncontrolled severe persistent asthma are selected for add-on therapy with omalizumab. Patients were on high dose of ICS and had a documented history of 2-6 exacerbations requiring treatment with systemic corticosteroids ( with >15 mg/day prednisone or other medications at similar dose, for at least 3 days). The individual dose and frequency of omalizumab administration is assessed from the dosing table. Lung function tests and asthma questionnaires (ACQ, AQLQ and RQLQ) are used in the aim of assessing clinical improvement after omalizumab treatment. Induced sputum (IS) and exhaled breath condensate (EBC) are used as a simple non-invasive methods for monitoring cellular and biochemical changes in the airways. Total blood eosinophil count, IS cytology, IS and EBC periostin and IL-6 concentrations are measured. Analyses are performed at entry and after 16, 52 and 104,156 weeks of omalizumab treatment.

Official Title
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Utility of Biomarkers in Evaluating Responsiveness to Anti-IgE (Omalizumab) in Severe Asthma Patients

Conditions
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Severe Asthma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: positive history of atopy serum total IgE level between 30 and 700 IU/ml body weight not more than 150 kg high dose of ICS and LABA a documented history of 2-6 exacerbations requiring treatment with systemic corticosteroids ( with >15 mg/day prednisone or other medications at similar dose, for at least 3 days). Exclusion Criteria: smoking pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in selected biomarkers in induced sputum | eosinophil count | baseline and after 156 weeks of omalizumab treament | 
| Change in selected biomarkers in peripheral blood | eosinophil count | baseline and after 156 weeks of omalizumab treament | 
| Change in selected biomarkers in induced sputum | periostin | baseline and after 156 weeks of omalizumab treament | 
| Change in selected biomarkers in exhaled breath condensate | periostin | baseline and after 156 weeks of omalizumab treament | 
| Change in selected biomarkers in induced sputum | IL-6 | baseline and after 156 weeks of omalizumab treament | 
| Change in selected biomarkers in exhaled breath condensate | IL-6 | baseline and after 156 weeks of omalizumab treament | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in selected biomarkers in induced sputum | eosinophils, periostin, IL-6 | baseline and after at 16,52,104 weeks of omalizumab treament | 
| Change in selected biomarkers in exhaled breath condensate | periostin, IL-6 | baseline and after at 16, 52, 104 weeks of omalizumab treament | 
| Change in selected biomarkers in peripheral blood | eosinophil count | baseline and after at 16, 52, 104 weeks of omalizumab treament | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe asthma, anti-IgE, periostin, induced sputum,, exhaled breath condensate