Identifying Serum Cytokine Profiles of Distinct Inflammatory Phenotypes in Severe Asthma

Study Overview
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Brief Summary
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The aim of this study is to determine and compare serum cytokine levels of six different severe asthma inflammatory phenotypes differentiated by their atopy, peripheral eosinophilia and/or chronic rhinosinusitis and/or nasal polyposis status.

Detailed Description
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A prospective observational study of 90 adults diagnosed with severe asthma and on regular follow-up and 15 control subjects will be investigated. Stable (controlled or partly-controlled) status (of all) and exacerbated-status (if any) serum cytokine levels [IL-4, IL-5, IL-10, IL-13, IL-25, IL-33, thymic stromal lymphopoietin (TSLP), IL-17A, periostin) will be evaluated. Also nasopharyngeal brush samples will be obtained for respiratory tract panel work-up with PCR in exacerbated patients. Effect of viral infections' on cytokine response in different inflammatory phenotypes will be evaluated.

Official Title
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Serum Cytokine Profiles of Severe Asthma

Conditions
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Asthma Persistent, Asthma, Allergic, Eosinophilic Asthma, Chronic Rhinosinusitis (Diagnosis)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (for disease groups): Patients diagnosed with severe asthma and followed-up at least 6 months at our clinic Asthma that can only be complete or partly controlled with Global Initiative for Asthma (GINA) 4-5 treatment Asthmatics that are eligible for the defined phenotypes At least one perennial allergen sensitivity for the atopic groups Inclusion Criteria (for control group): Non-asthmatics (without clinical and pulmonary function test evidence) Non-atopics (proved by skin prick tests) Serum eosinophil count <300/cells Exclusion Criteria (for disease groups): <18 year-old Smoking history within the last 1 year prior to the study Asthmatics with inadequate inhaler technique and/or adherence problems Comorbidities: malignancy history, connective tissue disorders, rheumatological disorders, hyperthyroidism, coronary heart diseases, diabetes mellitus, active hepatic diseases, akut kidney injury, any autoimmune diseases Organ transplantation history Pregnancy Other pulmonary problems: chronic obstructive pulmonary disease (COPD), bronchiectasis, interstitial lung diseases, pulmonary thromboemboli During stable period investigation Asthma control test <20 Upper respiratory tract infections within 1 month before admission Exacerbation and/or systemic steroid use within 1 month before admission Atopic patients that only have seasonal allergen sensitivity Inclusion Criteria (for control group): <18 year-old Smoking history within the last 1 year prior to the study Asthmatics with inadequate inhaler technique and/or adherence problems Comorbidities: malignancy history, connective tissue disorders, rheumatological disorders, hyperthyroidism, coronary heart diseases, diabetes mellitus, active hepatic diseases, akut kidney injury, any autoimmune diseases Organ transplantation history Pregnancy Other pulmonary problems: COPD, bronchiectasis, interstitial lung diseases, pulmonary thromboemboli Without consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Atopic, eosinophilic<br> | |
| Atopic, non-eosinophilic<br> | |
| Non-atopic, eosinophilic<br> | |
| Chronic rhinosinusitis with/without nasal polyposis<br> | |
| Non-atopic, non-eosinophilic<br> | |
| Control<br>Without asthma, atopy and eosinophilia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum cytokine levels | Measurement of stable state and exacerbation state levels of serum cytokines (IL-4, IL-5, IL10, IL-13, IL-17, IL-25, IL-33, TSLP, periostin) | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal brush sample PCR | Detecting pharyngeal pathogens with PCR taken during exacerbated state | 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe asthma, inflammatory phenotypes, serum cytokines, eosinophilia, atopy, chronic rhinosinusitis with nasal polyposis