Bronchial AsthmaNCT05366491
IL-38 Evaluation as a Biomarker in Pediatric Asthma
A study testing Il-38 serum level in people with Bronchial Asthma, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to investigate the associations between serum IL-38 levels and different variables of asthma in children such as laboratory variables, pulmonary function test results, the diagnosis of asthma, and in correlation with disease severity. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- Il-38 serum level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 15 Apr 2021
- Phase
- Interventional
- 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 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- patients fulfilled the criteria of the Global Initiative for Asthma (GINA)
- Age group:6-14 years
Who cannot join
- Malignancy
- Chronic inflammatory diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Human IL-38 Levels in Asthmatic Children
The aim of this study is to investigate the associations between serum IL-38 levels and different variables of asthma in children such as laboratory variables, pulmonary function test results, the diagnosis of asthma, and in correlation with disease severity.
- Conditions
- Bronchial Asthma
- Being tested
- Il-38 serum level
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Il-38 serum levelDiagnostic test
measurement of serum levels of IL-38
| Study group | Role | What they receive |
|---|---|---|
| bronchial asthma patients | Active comparator | patients diagnosed with bronchial asthma Receives: Diagnostic Test: Il-38 serum level |
| healthy controls | Active comparator | healthy subjects with age and sex matched to bronchial asthma patients Receives: Diagnostic Test: Il-38 serum level |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum IL-38 levels
Measurement of Interleukin 38 in sera of all study subjects by ELISA
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 Aug 2020
- Primary completion12 Jan 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mohamed Kamal, Cairo University
- Investigators
- Asmaa Kamal, Ass prof, Principal investigator, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366491
- Sponsor's protocol ID
- MS-25-2020
- Status last verified
- May 2022
- First submitted
- 5 May 2022
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Human IL-38 Levels in Asthmatic Children
- ClinicalTrials.gov ID
- NCT05366491
- Acronym / sponsor ID
- MS-25-2020
- Conditions
- Bronchial Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 12 Jan 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 9 May 2022 (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 investigate the associations between serum IL-38 levels and different variables of asthma in children such as laboratory variables, pulmonary function test results, the diagnosis of asthma, and in correlation with disease severity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bronchial asthma patients | Active comparator | Diagnostic Test: Il-38 serum levelpatients diagnosed with bronchial asthma |
| healthy controls | Active comparator | Diagnostic Test: Il-38 serum levelhealthy subjects with age and sex matched to bronchial asthma patients |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- patients fulfilled the criteria of the Global Initiative for Asthma (GINA)
- Age group:6-14 years
Key exclusion criteria (2 listed)
- Malignancy
- Chronic inflammatory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Il-38 serum levelmeasurement of serum levels of IL-38 | Diagnostic test | bronchial asthma patients, healthy controls |
Primary outcome
serum IL-38 levels
Time frame: within 6 months
Measurement of Interleukin 38 in sera of all study subjects by ELISA
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 12 May 2022.
- Individual participant dataSharing planned: No
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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.
Asmaa Kamal, Ass prof principal investigator
Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Il-38 serum level in people with Bronchial Asthma, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 2 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 12 May 2022. 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 Egypt. 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 IL-38 levels (time frame: within 6 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 12 May 2022.