Back to resultsIL-38 Evaluation as a Biomarker in Pediatric Asthma
Primary Purpose
Bronchial Asthma
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Il-38 serum level
Sponsored by
About this trial
This is an interventional diagnostic trial for Bronchial Asthma
Eligibility Criteria
Inclusion Criteria:
- patients fulfilled the criteria of the Global Initiative for Asthma (GINA)
- Age group:6-14 years
Exclusion Criteria:
- Malignancy
- Chronic inflammatory diseases
Sites / Locations
- Asmaa Kamal
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
bronchial asthma patients
healthy controls
Arm Description
patients diagnosed with bronchial asthma
healthy subjects with age and sex matched to bronchial asthma patients
Outcomes
Primary Outcome Measures
serum IL-38 levels
Measurement of Interleukin 38 in sera of all study subjects by ELISA
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05366491
Brief Title
IL-38 Evaluation as a Biomarker in Pediatric Asthma
Official Title
Serum Human IL-38 Levels in Asthmatic Children
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
January 12, 2021 (Actual)
Study Completion Date
April 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Asthma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bronchial asthma patients
Arm Type
Active Comparator
Arm Description
patients diagnosed with bronchial asthma
Arm Title
healthy controls
Arm Type
Active Comparator
Arm Description
healthy subjects with age and sex matched to bronchial asthma patients
Intervention Type
Diagnostic Test
Intervention Name(s)
Il-38 serum level
Intervention Description
measurement of serum levels of IL-38
Primary Outcome Measure Information:
Title
serum IL-38 levels
Description
Measurement of Interleukin 38 in sera of all study subjects by ELISA
Time Frame
within 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients fulfilled the criteria of the Global Initiative for Asthma (GINA)
Age group:6-14 years
Exclusion Criteria:
Malignancy
Chronic inflammatory diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asmaa Kamal, Ass prof
Organizational Affiliation
Assistant professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asmaa Kamal
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
IL-38 Evaluation as a Biomarker in Pediatric Asthma
We'll reach out to this number within 24 hrs