Asthma, Allergic, Asthma Persistent, Chronic Rhinosinusitis (Diagnosis), Eosinophilic Asthma
Conditions
Keywords
severe asthma, inflammatory phenotypes, serum cytokines, eosinophilia, atopy, chronic rhinosinusitis with nasal polyposis
Brief summary
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
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.
Interventions
None listed
Sponsors
TC Erciyes University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum cytokine levels | 10 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nasal brush sample PCR | 10 months | Detecting pharyngeal pathogens with PCR taken during exacerbated state |
Countries
Turkey (Türkiye)
Outcome results
None listed