Identifying Serum Cytokine Profiles of Distinct Inflammatory Phenotypes in Severe Asthma

Serum Cytokine Profiles of Severe Asthma

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• Turkey
  • Kayseri, Turkey, 38039
    • Erciyes University School of Medicine Division of Allergy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Asthmatic groups will be selected from the Erciyes University Allergy Clinic admisisons.

Control group wil be selected from the Erciyes University Allergy Clinic admisisons and from the volunteers.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
Atopic, eosinophilic
Atopic, non-eosinophilic
Non-atopic, eosinophilic
Chronic rhinosinusitis with/without nasal polyposis
Non-atopic, non-eosinophilic
Control; Without asthma, atopy and eosinophilia

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: TC Erciyes University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 27, 2017
• Primary Completion (ACTUAL): February 1, 2019
• Study Completion (ACTUAL): June 28, 2019

Study Registration Dates

• First Submitted: June 9, 2018
• First Submitted That Met QC Criteria: June 9, 2018
• First Posted (ACTUAL): June 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: atopy; severe asthma; eosinophilia; inflammatory phenotypes; serum cytokines; chronic rhinosinusitis with nasal polyposis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Leukocyte Disorders; Eosinophilia; Hypereosinophilic Syndrome; Asthma; Pulmonary Eosinophilia
• Other Study ID Numbers: astimsitokin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No