Asthma PersistentNCT03563521
Identifying Serum Cytokine Profiles of Distinct Inflammatory Phenotypes in Severe Asthma
An observational study of Asthma Persistent and Asthma, Allergic, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma Persistent, Asthma, Allergic, Eosinophilic Asthma
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Nov 2017to 28 Jun 2019
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
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- Serum eosinophil count <300/cells
- <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: COPD, bronchiectasis, interstitial lung diseases, pulmonary thromboemboli
- Without consent
Who cannot join
- <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
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University School of Medicine Division of Allergy
Kayseri, 38039
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma Persistent, Asthma, Allergic, Eosinophilic Asthma, Chronic Rhinosinusitis (Diagnosis)
- Keywords
- severe asthma, inflammatory phenotypes, serum cytokines, eosinophilia, atopy, chronic rhinosinusitis with nasal polyposis
- Medical subject headings
- Asthma, Pulmonary Eosinophilia, Disease, Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Atopic, eosinophilic | Not described | |
| Atopic, non-eosinophilic | Not described | |
| Non-atopic, eosinophilic | Not described | |
| Chronic rhinosinusitis with/without nasal polyposis | Not described | |
| Non-atopic, non-eosinophilic | Not described | |
| Control | Without asthma, atopy and eosinophilia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 10 months
Secondary outcomes (1)
Nasal brush sample PCR
Detecting pharyngeal pathogens with PCR taken during exacerbated state
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start27 Nov 2017
- Primary completion1 Feb 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma PersistentStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Türk, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563521
- Sponsor's protocol ID
- astimsitokin
- Status last verified
- Jul 2019
- First submitted
- 9 Jun 2018
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Cytokine Profiles of Severe Asthma
- ClinicalTrials.gov ID
- NCT03563521
- Acronym / sponsor ID
- astimsitokin
- Conditions
- Asthma Persistent, Asthma, Allergic, Eosinophilic Asthma, Chronic Rhinosinusitis (Diagnosis)
- Keywords
- severe asthma, inflammatory phenotypes, serum cytokines, eosinophilia, atopy, chronic rhinosinusitis with nasal polyposis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 20 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Atopic, eosinophilic | – | – |
| Atopic, non-eosinophilic | – | – |
| Non-atopic, eosinophilic | – | – |
| Chronic rhinosinusitis with/without nasal polyposis | – | – |
| Non-atopic, non-eosinophilic | – | – |
| Control | – | –Without asthma, atopy and eosinophilia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (12 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
Nasal brush sample PCR
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma Persistent and Asthma, Allergic, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum cytokine levels (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.