Identifying Serum Cytokine Profiles of Distinct Inflammatory Phenotypes in Severe Asthma

Chronic Rhinosinusitis (Diagnosis) Clinical Trial

Official title:

Serum Cytokine Profiles of Severe Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03563521
• Other study ID #: astimsitokin
• Status: Completed
• Start date: November 27, 2017
• Est. completion date: June 28, 2019

Study information

• Verified date: July 2019
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: June 28, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma Persistent
• Asthma, Allergic
• Chronic Disease
• Chronic Rhinosinusitis (Diagnosis)
• Eosinophilic Asthma
• Pulmonary Eosinophilia
• Sinusitis

Locations

Country	Name	City	State
Turkey	Erciyes University School of Medicine Division of Allergy	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Nasal brush sample PCR	Detecting pharyngeal pathogens with PCR taken during exacerbated state	10 months