Some Biomarkers in Bronchial Asthma in Children
A Study on Some Biomarkers in Bronchial Asthma in Children
1 other identifier
observational
105
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2019
CompletedFirst Posted
Study publicly available on registry
November 22, 2019
CompletedStudy Start
First participant enrolled
November 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 21, 2021
CompletedNovember 25, 2019
November 1, 2019
12 months
November 20, 2019
November 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Mild persistent asthma
• Group I, patients with mild persistent asthma.
Moderate persistent asthma
• Group II, patients with moderate persistent asthma.
Severe persistent asthma
• Group III ,patients with severe persistent asthma.
Interventions
measurement by ELISA of asymmetric dimethylarginine
Eligibility Criteria
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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
November 20, 2019
First Posted
November 22, 2019
Study Start
November 29, 2019
Primary Completion
November 21, 2020
Study Completion
November 21, 2021
Last Updated
November 25, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share