Some Biomarkers in Bronchial Asthma in Children

A Study on Some Biomarkers in Bronchial Asthma in Children

Asthma, a disease characterized by chronic airway inflammation and hyper -responsiveness, is a common disease that affects all age groups. Asthma may be manifested as irreversible airflow obstruction in some patients. Although the pathogenesis of asthma is not well understood, increased oxidative stress due to an imbalance of oxidants and antioxidants has been found to be associated with asthma. In asthma, inflammation-related oxidative stress is driven by exposure to a variety of triggers, including allergens and viruses, which activate components of both the innate and acquired immune responses. Protection by escaping from triggering factors or standardization of asthma medication is difficult and usually is not enough for effective treatment. On the other hand, correction of antioxidative systems may be more efficacious in the control of asthmatic inflammation and asthma symptoms.

Little is known about the role of asymmetric dimethylarginine in the pathogenesis of asthmatic airway inflammation. The lung is a major source of asymmetric dimethylarginine that can promote oxidative stress by a reduction in nitric oxide synthesis which would result in higher levels of peroxynitrite, that causes oxidative cell damage, and exacerbate airway inflammation. asymmetric dimethylarginine can modify lung function, increase airway hyper-reactivity even in non-inflamed airways, and promote lung collagen production and deposition. Increased asymmetric dimethylarginine in serum has been found to be associated with the severity of symptoms of asthma in obese adults.

Malondialdehyde is an oxidant marker of pulmonary oxidative stress, and lipid peroxidation. Paraoxonase, an antioxidant enzyme may play a protective role in asthma. It hydrolyzes lipid peroxides and prevents low-density lipoprotein oxidation.

Study Overview

• Status: Unknown
• Conditions: Bronchial Asthma
• Intervention / Treatment: Diagnostic test: asymmetric dimethylarginine

• Study Type: Observational
• Enrollment (Anticipated): 105

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All the children included in the study will be exposed to full clinical examination and history for assessment of severity of asthma in patient groups according to the guidelines for diagnosis and managemt of asthma 2007.

Description

• All known asthmatic patients aged six years or more who will be regularly attending Assuit University Children's Hospital Outpatient clinic.

Exclusion criteria include

• Obese children,
• The presence of chronic heart, liver and kidney diseases, concomitant chronic inflammatory disease and autoimmune disorders, and Diabetes mellitus.
• Patients taking antioxidant drugs, vitamins, diuretics, hormone replacement therapy will be also excluded.
• Children aged less than six years. 5-children who have symptoms of lower or upper respiratory tract infection or asthma exacerbation within the previous four weeks.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mild persistent asthma; • Group I, patients with mild persistent asthma.	Diagnostic test: asymmetric dimethylarginine; measurement by ELISA of asymmetric dimethylarginine
Moderate persistent asthma; • Group II, patients with moderate persistent asthma.	Diagnostic test: asymmetric dimethylarginine; measurement by ELISA of asymmetric dimethylarginine
Severe persistent asthma; • Group III ,patients with severe persistent asthma.	Diagnostic test: asymmetric dimethylarginine; measurement by ELISA of asymmetric dimethylarginine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of asymmetric dimethylarginine in the study groups	measurement from serum samples by competitive ELISA with a standard range from 0.1 to 5.0 μmol/L.	24 hours

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 29, 2019
• Primary Completion (Anticipated): November 21, 2020
• Study Completion (Anticipated): November 21, 2021

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): November 25, 2019
• Last Update Submitted That Met QC Criteria: November 21, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; N,N-dimethylarginine
• Other Study ID Numbers: BRASTHMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No