Identifying Serum Cytokine Profiles of Distinct Inflammatory Phenotypes in Severe Asthma

TC Erciyes University95 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria (for disease groups): 1. Patients diagnosed with severe asthma and followed-up at least 6 months at our clinic 2. Asthma that can only be complete or partly controlled with Global Initiative for Asthma (GINA) 4-5 treatment 3. Asthmatics that are eligible for the defined phenotypes 4. At least one perennial allergen sensitivity for the atopic groups Inclusion Criteria (for control group): 1. Non-asthmatics (without clinical and pulmonary function test evidence) 2. Non-atopics (proved by skin prick tests) 3. Serum eosinophil count \<300/cells Exclusion Criteria (for disease groups): 1. \<18 year-old 2. Smoking history within the last 1 year prior to the study 3. Asthmatics with inadequate inhaler technique and/or adherence problems 4. Comorbidities: malignancy history, connective tissue disorders, rheumatological disorders, hyperthyroidism, coronary heart diseases, diabetes mellitus, active hepatic diseases, akut kidney injury, any autoimmune diseases 5. Organ transplantation history 6. Pregnancy 7. Other pulmonary problems: chronic obstructive pulmonary disease (COPD), bronchiectasis, interstitial lung diseases, pulmonary thromboemboli 8. During stable period investigation 1. Asthma control test \<20 2. Upper respiratory tract infections within 1 month before admission 3. Exacerbation and/or systemic steroid use within 1 month before admission 9. Atopic patients that only have seasonal allergen sensitivity Inclusion Criteria (for control group): 1. \<18 year-old 2. Smoking history within the last 1 year prior to the study 3. Asthmatics with inadequate inhaler technique and/or adherence problems 4. Comorbidities: malignancy history, connective tissue disorders, rheumatological disorders, hyperthyroidism, coronary heart diseases, diabetes mellitus, active hepatic diseases, akut kidney injury, any autoimmune diseases 5. Organ transplantation history 6. Pregnancy 7. Other pulmonary problems: COPD, bronchiectasis, interstitial lung diseases, pulmonary thromboemboli 8. Without consent

Locations (1)

Erciyes University School of Medicine Division of Allergy

Kayseri, Turkey (Türkiye)

Outcomes

Primary Outcomes

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)

Time frame: 10 months

Secondary Outcomes

Nasal brush sample PCR

Detecting pharyngeal pathogens with PCR taken during exacerbated state

Time frame: 10 months

Data from ClinicalTrials.gov

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