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Identifying Serum Cytokine Profiles of Distinct Inflammatory Phenotypes in Severe Asthma

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ClinicalTrials.gov Identifier: NCT03563521
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Murat Türk, 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.

Condition or disease
Asthma Persistent Asthma, Allergic Eosinophilic Asthma Chronic Rhinosinusitis (Diagnosis)

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 [Patient Registry]
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Serum Cytokine Profiles of Severe Asthma
Actual Study Start Date : November 27, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Serum cytokine levels [ Time Frame: 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 :
  1. Nasal brush sample PCR [ Time Frame: 10 months ]
    Detecting pharyngeal pathogens with PCR taken during exacerbated state


Biospecimen Retention:   Samples Without DNA
Serum nasopharyngeal brush (to detect pharyngeal tract pathogens with PCR)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563521


Locations
Turkey
Erciyes University School of Medicine Division of Allergy Recruiting
Kayseri, Turkey, 38039
Contact: İnsu Yılmaz    00905056690640    insu2004@yahoo.com   
Sponsors and Collaborators
TC Erciyes University

Responsible Party: Murat Türk, Principal Investigator, TC Erciyes University
ClinicalTrials.gov Identifier: NCT03563521     History of Changes
Other Study ID Numbers: astimsitokin
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Murat Türk, TC Erciyes University:
severe asthma
inflammatory phenotypes
serum cytokines
eosinophilia
atopy
chronic rhinosinusitis with nasal polyposis

Additional relevant MeSH terms:
Asthma
Pulmonary Eosinophilia
Sinusitis
Chronic Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hypereosinophilic Syndrome
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes