Dupilumab Efficacy on Bronchial Inflammation, Small Airways Disfunction and Mucous Secretion

Study Overview
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Brief Summary
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Unicentric prospective real life study designed to analyse the efficacy of Dupilumab to reduce bronchial inflammation of asthma measured by inflammatory cell counts obtained in induced sputum and other related characteristics (small airway dysfunction and mucin production) in uncontrolled severe asthma patients in the real life setting without control group

Detailed Description
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After patients signed informed consent, before (visit 1), after 4-5 months (visit 2), and after 12 months (visit 3) Dupilumab treatment began, the following techniques and measurements will be performed or collected: demographic data, blood analyses (eosinophil counts and total IgE), skin prick-test to common aeroallergens (only in the visit 1), asthma control test (ACT), sino-nasal outcome test (SNOT-22), test of adherence to inhalers (TAI), number of severe asthma exacerbations (in the previous year; in the visit 2, in the previous 4 months), oral and inhaled steroid daily doses received, spirometry, exhaled nitric oxide (FeNO), pulmonary volumes, carbon monoxide transference, oscillometry, and induced sputum (inflammatory cell counts and mucin profile [MUC1, MUC2, MUC5AC, MUC5B]). All patients will be performed at visits 1 and 3 in a 3D culture of primary nasal epithelial cells from asthmatic patients the pattern of gene and to identify new soluble biomarkers through quantitative proteomic analysis of culture supernatants. Also a chest CT scan with expiratory images will be done only in visits 1 and 3.

Official Title
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Dupilumab Efficacy on Bronchial Inflammation, Small Airways Disfunction and Mucous Secretion in the Real Life Severe Asthma Patients

Conditions
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Asthma; Eosinophilic

Intervention / Treatment
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* Biological: Dupilumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 -80 years Severe uncontrolled eosinophilic asthma by GINA (Global Initiative for Asthma) criteria Clinical indication of Dupilumab Exclusion Criteria: Smoking over 10 pack/year Treatment with monoclonal antibodies treatment during the previous three months Refuse to sign informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Dupilumab|600 mg (two 300 mg injections), followed by 300 mg monthly|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of bronchial inflammatory cells | Count of induced sputum leucocytes | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucin production from epithelial cells | Levels of MUC 1, MUC2, MUC5AC, and MUC5B | 1 year |