Identifying Serum Cytokine Profiles of Distinct Inflammatory Phenotypes in Severe Asthma

Completed

• Conditions: Chronic Rhinosinusitis (Diagnosis); Asthma Persistent; Asthma, Allergic; Eosinophilic Asthma

• Registration Number: NCT03563521
• Lead Sponsor: TC Erciyes University

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.

Study Timeline

• Study Start: 2017-11-27
• Study First Submitted: 2018-06-09
• Study First Submitted QC: 2018-06-09
• Study First Posted: 2018-06-20
• Primary Completion: 2019-02-01
• Study Completion: 2019-06-28
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-17
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Nasal brush sample PCR	10 months	Detecting pharyngeal pathogens with PCR taken during exacerbated state

Trial Locations

Locations (1)

Erciyes University School of Medicine Division of Allergy; 🇹🇷 Kayseri, Turkey