Identifying Serum Cytokine Profiles of Distinct Inflammatory Phenotypes in Severe Asthma

NCT03563521 | Completed

• 1 other identifier: astimsitokin
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

severe asthma; inflammatory phenotypes; serum cytokines; eosinophilia; atopy; chronic rhinosinusitis with nasal polyposis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Nasal brush sample PCR

  10 months

Study Arms (6)

Atopic, eosinophilic

Atopic, non-eosinophilic

Non-atopic, eosinophilic

Chronic rhinosinusitis with/without nasal polyposis

Non-atopic, non-eosinophilic

Control

Without asthma, atopy and eosinophilia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients diagnosed with severe asthma and followed-up at least 6 months at our clinic
• Asthma that can only be complete or partly controlled with Global Initiative for Asthma (GINA) 4-5 treatment
• Asthmatics that are eligible for the defined phenotypes
• At least one perennial allergen sensitivity for the atopic groups
• Non-asthmatics (without clinical and pulmonary function test evidence)
• Non-atopics (proved by skin prick tests)
• Serum eosinophil count \<300/cells

You may not qualify if:

• \<18 year-old
• Smoking history within the last 1 year prior to the study
• Asthmatics with inadequate inhaler technique and/or adherence problems
• Comorbidities: malignancy history, connective tissue disorders, rheumatological disorders, hyperthyroidism, coronary heart diseases, diabetes mellitus, active hepatic diseases, akut kidney injury, any autoimmune diseases
• Organ transplantation history
• Pregnancy
• Other pulmonary problems: chronic obstructive pulmonary disease (COPD), bronchiectasis, interstitial lung diseases, pulmonary thromboemboli
• During stable period investigation
• Asthma control test \<20
• Upper respiratory tract infections within 1 month before admission
• Exacerbation and/or systemic steroid use within 1 month before admission
• Atopic patients that only have seasonal allergen sensitivity
• \<18 year-old
• Smoking history within the last 1 year prior to the study
• Asthmatics with inadequate inhaler technique and/or adherence problems

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University School of Medicine Division of Allergy

Kayseri, 38039, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum nasopharyngeal brush (to detect pharyngeal tract pathogens with PCR)

MeSH Terms

Conditions

Asthma; Pulmonary Eosinophilia; Disease; Eosinophilia

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Hypereosinophilic Syndrome; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2018
• First Posted: June 20, 2018
• Study Start: November 27, 2017
• Primary Completion: February 1, 2019
• Study Completion: June 28, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

TU (1)