NCT05366491

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

May 5, 2022

Last Update Submit

May 8, 2022

Conditions

Bronchial Asthma

Outcome Measures

Primary Outcomes (1)

  • serum IL-38 levels

    Measurement of Interleukin 38 in sera of all study subjects by ELISA

    within 6 months

Study Arms (2)

bronchial asthma patients

ACTIVE COMPARATOR

patients diagnosed with bronchial asthma

Diagnostic Test: Il-38 serum level

healthy controls

ACTIVE COMPARATOR

healthy subjects with age and sex matched to bronchial asthma patients

Diagnostic Test: Il-38 serum level

Interventions

Il-38 serum levelDIAGNOSTIC_TEST

measurement of serum levels of IL-38

bronchial asthma patientshealthy controls

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • patients fulfilled the criteria of the Global Initiative for Asthma (GINA)
  • Age group:6-14 years

You may not qualify if:

  • Malignancy
  • Chronic inflammatory diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asmaa Kamal

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Asmaa Kamal, Ass prof

    Assistant professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 5, 2022

First Posted

May 9, 2022

Study Start

August 1, 2020

Primary Completion

January 12, 2021

Study Completion

April 15, 2021

Last Updated

May 12, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)